Overview:
Early clinical trial phases are conducted to establish initial safety of a drug. The drug trial studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required.
In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has allowed early stage investigational products to be manufactured under less stringent GMP guidelines.
Why Should You Attend:
This webinar will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail.
Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.
Areas Covered in this Webinar:
FDA regulations and Guidance Documents for Phase I clinical trials
Key elements and Best practices of GMP for Phase I clinical trials
IND content and format for CMC information
Vendor selection and management for outsourcing early manufacturing
Raw material selections and considerations
Learning Objectives:
Understand the differences permitted for phase I GMP compliance regulations
Ensure that all of the right systems and procedures are in place
Who Will Benefit:
Directors
Managers/Supervisors
Regulatory Affairs
Manufacturing
Quality Assurance and Clinical Operations
For more information, please visit : https://www.complianceglobal.us/product/700524/PeggyJBerry/gmps-for-phase-i-clinical-studies/1
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile:
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).
She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book Choosing the Right Regulatory Career (RAPS, MD) and author of the 2011 book Communication & Negotiation (RAPS, MD).
Phase I GMPs - By Compliance Global Inc
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3rd Bioequivalence Summit
Every new formulation and generic drug needs to demonstrate bioequivalence to secure market approval. But each of these required tests can be complicated by innovations in drug delivery or dosing features, yielding unpredictable challenges if companies modify delivery techniques to try to improve bioavailability.
The 3rd Bioequivalence Summit is your must-attend event for achieving true interchangeability of both small molecule generics and biosimilars across multiple delivery platforms. No other conference goes into as much depth of scientific detail in order to help broaden the robustness and market uptake of your generic and biosimilar portfolio.
URLs
Booking: https://go.evvnt.com/64891-1
Brochure: https://go.evvnt.com/64891-2
Price
Conference - Early Bird Price before August 12th, 2016: USD 1895.00
Conference Standard Pricing after August 12th, 2016: USD 2095.00
Speakers: Joe Fuhr, Widener University, Sudhakar Koundinya, Dr. Reddy's Laboratories, Meena Venugopal, Alvogen Pharma, John Caminis, Baxalta, DongZhou Liu, PhD, GlaxoSmithKline, Isadore Kanfer, Leslie Dan Faculty of Pharmacy, Amitava Mitra, Merck & Co. Inc., Shrinivas Savale, Torrent Pharmaceuticals ltd., Audra Stinchcomb, University of Maryland School of Pharmacy, Magdalena Leszczyniecka, STC Biologics, Jerome Schentag, The University of Buffalo, Zahra Shahrokh, STC Biologics
Time: On Monday September 26, 2016 at 8:00 am (ends Tuesday September 27, 2016 at 4:00 pm)
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Lymphoma and Myeloma 2016
It is our pleasure to invite you to join us for Lymphoma and Myeloma 2016: An International Congress on Hematologic Malignancies. This falls congress, October 13-15, 2016, will once again be held at the beautiful and historic Waldorf Astoria Hotel in New York, New York.
For the past sixteen years, LandM has been the premier forum on the latest advances in lymphoma and myeloma. Over forty internationally-recognized leaders in molecular biology, pathology, immunology, translational and clinical research have been involved to provide expertise and guidance on recent developments in the basic science, translational medicine and clinical trials. The Congress features an interdisciplinary approach, special lectures, debates and interactive techniques to explore the controversial, the upcoming, and the exciting in myeloma, Waldenstroms macroglobulinemia, chronic lymphatic leukemia, lymphoma and Hodgkins disease.
And, for the first time ever, the Lymphoma Research Foundation will hold its National Lymphoma Rounds Summit, a conference focused on highlights and breaking news in lymphoma, directly after Lymphoma and Myeloma 2016, on Sunday, October 16 at the Waldorf Astoria Hotel.
We look forward to seeing you in New York. Its the perfect opportunity to visit this premier city and the beautiful Waldorf Astoria Hotel.
URLs:
Tickets: https://go.evvnt.com/64873-1
Facebook: https://go.evvnt.com/64873-2
YouTube: https://go.evvnt.com/64873-3
Brochure: https://go.evvnt.com/64873-4
Prices:
Early Registration - Physician, Pharmacist, Researcher (until Sept 1): USD 499.00
Discounted Registration - Physician, Pharmacist, Researcher (until Sept 29): USD 599
Regular/Onsite Registration - Physician, Pharmacist, Researcher (after Sept 29): USD 699
Early Registration - PA/NP (until Sept 1): USD 299
Discounted Registration - PA/NP (until Sept 29): USD 349
Regular/Onsite Registration - PA/NP (after Sept 29): USD 399
Early Registration - Nurse, Fellow, Resident, Student/Trainee (until Sept 1): USD 199
Discounted Registration - Nurse, Fellow, Resident, Student/Trainee (until Sept 29): USD 249
Regular/Onsite Registration - Nurse, Fellow, Resident, Student/Trainee (after Sept 29): USD 299
Pharmaceutical Industry Personnel: USD 800
Speakers: Morton Coleman MD, John P. Leonard MD, Ruben Niesvizky MD, Richard R. Furman, Jeremy Abramson MD, Ranjana Advani MD, John N. Allan MD, Kenneth C. Anderson MD, Bart Barlogie MD, Jennifer R. Brown MD PhD, George P. Canellos MD FASCO, Lewis Clayton Cantley PhD BS, Leandro Cerchietti MD, Robert W. Chen MD, Selina Chen-Kiang PhD, Bruce D. Cheson MD, Steven Coutre MD, Kieron Dunleavy MD, Scott A. Ely MD MPH, Rafael Fonseca MD, Francesca Gay MD, Peter Hillmen MB ChB PhD, Swaminathan Padmanabhan Iyer MD, Neil E. Kay MD, Ann S. LaCasce MD, C. Ola Landgren MD PhD, David G. Maloney MD PhD, Tomer M. Mark Md MSc, Peter Martin MD, Maria-Victoria Mateos MD PhD, Joseph R. Mikhael MD MEd FRCPC FACP, Phillippe Moreau MD, Alison J. Moskowitz MD, Chadi Nabhan MD FACP, Antonio Palumbo MD, Kanti Rai MD, Kristy Richards MD PhD, Paul G. Richardson MD, Adriana C. Rossi MD, Lisa G. Roth MD, Jia Ruan MD PhD, David S. Siegel MD PhD, Sonali M. Smith MD, David Straus MD, Kelly Trevino PhD, Koen van Besien MD PhD, Y. Lynn Wang MD PhD FACP, David Weinstock MD
Time: 8:00 am - 4:00 pm
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GMP Compliance for Quality Control Laboratories 2016
Overview:
Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation.
This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation.
Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, participants will work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned from the course.
Learning Objectives:
Learn about the regulatory background and GMP requirements for quality control and contract laboratories.
Understand and be able to explain your company's quality plan or laboratory compliance master plan.
Understand the difference between GMP and non-GMP laboratories.
Learn how to develop inspection ready documentation.
Be able to train others in your organization on GMP requirements.
Learn how to avoid and/or respond to the FDA inspectional observations and warning letters.
Complimentary Hand-outs:
For easy implementation, attendees will receive free access to "Laboratory Compliance Package" as Web download.
This package includes 46 SOPs, a compliance master plan, checklist and templates that help to implement GMP requirements in laboratories
50-Page primer: FDA GMP Compliance in Analytical Laboratories
Laboratory Compliance Master Plan
Worksheet - Laboratory Audits
Following Standard Operating Procedures:
Who Should Attend:
This seminar will be beneficial to the following personnel in FDA regulated laboratories:
Analysts and lab managers
QA managers and personnel
Validation specialists
Regulatory affairs
IT professionals
Human resources (HR) managers and staff
Training departments
Documentation department
Consultants& teachers
Agenda:
Day 1 Schedule:
Lecture 1: FDA Regulations and Requirements Overview
FDA 21 CFR Part 211 and 21 CFR Part 11
Most frequently cited FDA 483s and warning letters
Requirements overview from sampling to archiving
Quality system requirements, e.g., ICH Q10
The concept and practice of risk based compliance
Lecture 2: Planning for quality and cGMP compliance
Developing and using a validation master plan
Scope, objectives and key elements of the master plan
Developing and using FDA compliant SOPs
Using templates to generate inspection ready documentation
Planning for efficiency cost-effectiveness
Lecture 3: Calibration and Qualification of Laboratory Equipment
FDA requirements
USP chapter for instrument qualification
Going through examples for qualification steps(DQ, IQ, OQ, PQ)
SOPs and deliverables for three instrument categories
Developing calibration and qualification protocols
Lecture 4: Equipment Maintenance and Change control
Preventive maintenance; tasks, documentation
Planned and unplanned changes
Changing hardware, firmware, documentation
Definition and handling of like-for-like changes.
Requalification: time and event based
Lecture 5: Validation of Laboratory Computer Systems
Going through the new GAMP® guide: "A Risk based Approach to Laboratory Computerized Systems"
Going through a complete laboratory computer system validation from beginning to end
Integration the GAMP® guide with USP
Periodic evaluation to reduce revalidation efforts
Revalidation: why, what, when
Lecture 6: Validation of Analytical Methods and Procedures
Parameters and tests according to ICH Q2
Developing a validation plan, protocols and a report
Setting acceptance criteria for different applications
Verification of compendia methods according to USP
Transfer of analytical procedures according to the new USP
Day 2 Schedule:
Lecture 1: Sample Testing: Preparation, conduct, documentation
Preparing the equipment
Setting specifications and acceptance criteria
Documentation of test results
Review and approval
Not to forget: Review of electronic audit trail
Lecture 2: Handling out of specification (OOS) test results
Going through the FDA OOS guide
Learning from recent FDA warning letters
Going through an OOS checklist
Using out of trend (OOT) data to avoid OOS results
Documentation and follow-up: root cause, corrective action plan, preventive action plan
Lecture 3: Quality assurance of reference standards and other supplies
Supplier qualification vs. sample testing
Selection and assessment of suppliers
Retesting of materials
Preparing working standards from reference standards
Correct labeling of chemicals
Lecture 4: Training for GMP compliance
FDA requirements
identification of training needs
Developing a training plan
Making GMP training interesting
Documenting effectiveness of training
Lecture 5: Ensuring Integrity of Raw Data and Other records
FDA Part 11 and EU-PIC/S Annex 11 requirements
Definition of Raw Data: Electronic vs. paper
Acquisition and recording of raw data
The importance of electronic audit trail
Archiving of electronic records for 'ready retrieval'
Lecture 6: Internal audits in preparation for FDA inspection
Scheduling of audits
FDA Inspections as model for laboratory audits
Going through a typical FDA laboratory inspection
Responding to Typical inspectional/audit deviation
How to avoid FDA 483s and warning letters
Lecture 7: Wrap up - Final questions and answers
Speaker:
Dr. Ludwig Huber
Chief Advisor - Global FDA compliance, Agilent Technologies
Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.
Presenter of the Year of the Institute for Validation and Technology
Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories.
Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"
Location: Mumbai, India Date: January 23rd and 24th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: The Leela Mumbai
Address: Andheri Kurla Road, Sahar Village, Andheri-Kurla Road, Mumbai, Maharashtra 400059
Price:
Register now and save ¹ 2000. (Early Bird)
Until December 10, Early Bird Price: ¹ 14,000 from December 11 to January 21, Regular Price: ¹ 16,000
Registration Details:
NetZealous - GlobalCompliancePanel
NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka, INDIA
Phone: 1800 425 9409
Fax: 080-25149544
customersupport@globalcompliancepanel.com
http://www.globalcompliancepanel.in/
Registration Link - http://www.globalcompliancepanel.in/control/GMP-for-quality-control
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
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GMP Compliance for Quality Control Laboratories 2016
Overview:
Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation.
This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation.
Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, participants will work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned from the course.
Learning Objectives:
Learn about the regulatory background and GMP requirements for quality control and contract laboratories.
Understand and be able to explain your company's quality plan or laboratory compliance master plan.
Understand the difference between GMP and non-GMP laboratories.
Learn how to develop inspection ready documentation.
Be able to train others in your organization on GMP requirements.
Learn how to avoid and/or respond to the FDA inspectional observations and warning letters.
Complimentary Hand-outs:
For easy implementation, attendees will receive free access to "Laboratory Compliance Package" as Web download.
This package includes 46 SOPs, a compliance master plan, checklist and templates that help to implement GMP requirements in laboratories
50-Page primer: FDA GMP Compliance in Analytical Laboratories
Laboratory Compliance Master Plan
Worksheet - Laboratory Audits
Following Standard Operating Procedures:
Who Should Attend:
This seminar will be beneficial to the following personnel in FDA regulated laboratories:
Analysts and lab managers
QA managers and personnel
Validation specialists
Regulatory affairs
IT professionals
Human resources (HR) managers and staff
Training departments
Documentation department
Consultants& teachers
Agenda:
Day 1 Schedule:
Lecture 1: FDA Regulations and Requirements Overview
FDA 21 CFR Part 211 and 21 CFR Part 11
Most frequently cited FDA 483s and warning letters
Requirements overview from sampling to archiving
Quality system requirements, e.g., ICH Q10
The concept and practice of risk based compliance
Lecture 2: Planning for quality and cGMP compliance
Developing and using a validation master plan
Scope, objectives and key elements of the master plan
Developing and using FDA compliant SOPs
Using templates to generate inspection ready documentation
Planning for efficiency cost-effectiveness
Lecture 3: Calibration and Qualification of Laboratory Equipment
FDA requirements
USP chapter for instrument qualification
Going through examples for qualification steps(DQ, IQ, OQ, PQ)
SOPs and deliverables for three instrument categories
Developing calibration and qualification protocols
Lecture 4: Equipment Maintenance and Change control
Preventive maintenance; tasks, documentation
Planned and unplanned changes
Changing hardware, firmware, documentation
Definition and handling of like-for-like changes.
Requalification: time and event based
Lecture 5: Validation of Laboratory Computer Systems
Going through the new GAMP® guide: "A Risk based Approach to Laboratory Computerized Systems"
Going through a complete laboratory computer system validation from beginning to end
Integration the GAMP® guide with USP
Periodic evaluation to reduce revalidation efforts
Revalidation: why, what, when
Lecture 6: Validation of Analytical Methods and Procedures
Parameters and tests according to ICH Q2
Developing a validation plan, protocols and a report
Setting acceptance criteria for different applications
Verification of compendia methods according to USP
Transfer of analytical procedures according to the new USP
Day 2 Schedule:
Lecture 1: Sample Testing: Preparation, conduct, documentation
Preparing the equipment
Setting specifications and acceptance criteria
Documentation of test results
Review and approval
Not to forget: Review of electronic audit trail
Lecture 2: Handling out of specification (OOS) test results
Going through the FDA OOS guide
Learning from recent FDA warning letters
Going through an OOS checklist
Using out of trend (OOT) data to avoid OOS results
Documentation and follow-up: root cause, corrective action plan, preventive action plan
Lecture 3: Quality assurance of reference standards and other supplies
Supplier qualification vs. sample testing
Selection and assessment of suppliers
Retesting of materials
Preparing working standards from reference standards
Correct labeling of chemicals
Lecture 4: Training for GMP compliance
FDA requirements
identification of training needs
Developing a training plan
Making GMP training interesting
Documenting effectiveness of training
Lecture 5: Ensuring Integrity of Raw Data and Other records
FDA Part 11 and EU-PIC/S Annex 11 requirements
Definition of Raw Data: Electronic vs. paper
Acquisition and recording of raw data
The importance of electronic audit trail
Archiving of electronic records for 'ready retrieval'
Lecture 6: Internal audits in preparation for FDA inspection
Scheduling of audits
FDA Inspections as model for laboratory audits
Going through a typical FDA laboratory inspection
Responding to Typical inspectional/audit deviation
How to avoid FDA 483s and warning letters
Lecture 7: Wrap up - Final questions and answers
Speaker:
Dr. Ludwig Huber
Chief Advisor - Global FDA compliance, Agilent Technologies
Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.
Presenter of the Year of the Institute for Validation and Technology
Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories.
Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"
Location: Mumbai, India Date: January 23rd and 24th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: The Leela Mumbai
Address: Andheri Kurla Road, Sahar Village, Andheri-Kurla Road, Mumbai, Maharashtra 400059
Price:
Register now and save ¹ 2000. (Early Bird)
Until December 10, Early Bird Price: ¹ 14,000 from December 11 to January 21, Regular Price: ¹ 16,000
Registration Details:
NetZealous - GlobalCompliancePanel
NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka, INDIA
Phone: 1800 425 9409
Fax: 080-25149544
customersupport@globalcompliancepanel.com
http://www.globalcompliancepanel.in/
Registration Link - http://www.globalcompliancepanel.in/control/GMP-for-quality-control
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
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Healthcare IT Exchange
Examining Tools and Strategies that Enable Personalised Healthcare
The Healthcare IT Exchange represents the annual meeting point of the most senior and influential informatics leaders from NHS, private care providers and other similar European organizations where the intricacies surrounding the infrastructure of personalized and integrated healthcare, will be addressed with a view to uncover innovative ideas and solutions from a strategic as well as technical perspective.
This event has been designed to stimulate pioneering thinking for the leaders tasked with the complex technological challenge whilst having to manage shrinking budgets and increasing demands for capability and capacity as well as handle objections from clinical groups.
Expert speakers this year will include:
Chelsea and Westminster Hospital, Associate Medical Director for Clinical Informatics and Transformation
Sheffield Teaching Hospital, Head of Technical Architecture, Strategy and Planning
Cambridge University Hospitals NHS Foundation Trust, Chief Information Officer
Alongside cutting edge and interactive agenda sessions, attendees will have the exclusive opportunity to meet with innovative, future thinking customer experience solution providers.
Very informative and worth taking the time out to spend exchanging ideas and focused on Health issues, risks, changes and successes. Head of ICT, ABHB
For more information or to register:
Tel: +44 207 368 9484
Email: exchangeinfo@iqpc.com
Visit: http://bit.ly/2b2NHR5
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Research Use Only Products the Dos and Donts - By Compliance Global Inc
Overview:
For the past 30 plus years, the label For Research Use Only has been confusing to many medical and research professionals as well as marketing and sales personnel.
Additionally, these products remain unregulated without Food and Drug Administration (FDA) oversight. As the industry transitions into the age of molecular diagnostics to remain innovative with the pharmaceutical industry efforts to develop medical products for unmet medical needs, FDA regulatory oversight is need more than ever.
Although these products remain an important commercial class, a regulatory framework to regulate their development, manufacture and distribution for the appropriate laboratory intended use.
The topics for discussion in this webinar will be summarized to provide lists of dos and donts for marketing, sales personnel, manufacturers and research professionals to achieve their goals, remain compliant and to develop products that will be safe and effective for use in patients. An appropriate regulatory framework will promote innovation for those unmet medical needs instead of being an obstacle to it.
For medical professionals involved with clinical development of drugs and medical devices, they are well educated that the Food and Drug Administration (FDA) is the regulating agency that provides the regulatory requirements necessary for final approval.
Additionally, medical devices intended for clinical diagnostic use and the FDA also actively regulates diagnostic kits, which are intended for the same clinical use. In contrast however, Research Use Only (RUOs) products are unregulated. Research Use Only products are often discussed as medical devices but they are not devices but an important commercial class of products.
Although unregulated, RUOs are mentioned briefly in 21 Code of Federal Regulations. For the past 30 years, these important commercial products, used in both basic and clinical laboratories, have been the subject of intense discussion on how to regulate their distribution and used for the appropriate laboratory use.
One of the confusing points of discussion has been the name used as labels for these products. Some manufacturers label them research use only, others use investigational use devices (IVD) while others use investigational use only (IUO). With technology and innovation directing the development of drug products for unmet medical needs, the age of molecular diagnostics is very much a part of the clinical research industry.
Therefore it is increasingly important to provide a regulatory framework for manufacturers, marketers and sellers of these products to have guidelines to follow when approaching the clinical community. Ultimately, Congress will have to provide the amendment to the Food, Drug and Cosmetic Act that will provide that regulatory framework for an important commercial product in clinical development.
Why Should You Attend:
This webinar is an important first step for both professionals, both marketing and sales, to take as they promote and distribute Research Use Only (RUOs) for use by medical professional in clinical laboratories and investigational ones as well. RUOs are important commercially available products that have been in both basic and clinical laboratories.
With the constant change in technology in both medical devices and products used in the clinical diagnosis of diseases, marketing professionals need to have knowledge as to the regulation requirements for their specific products.
Many of the RUOs are used clinically to determine the appropriate treatment regimens to use to therapeutically resolve these medical issues.
Participates will be navigated on a chronological path of FDA attempts to regulate Research Use Only products, a path that has spanned 30 years with an increasing focus towards regulatory requirement in the past 3 years.
Areas Covered in this Webinar:
Research Use Only (RUOs) has and plays a significant role in clinical development including the drug development process clinical trials. Although unregulated by the FDA, attendees will learn about the Code of Federal Regulations which plays a major role in the regulatory and labeling requirements of RUOs that both manufactures and sales representative need to be aware of.
This webinar will also discuss the several Guidance Documents issued by the FDA in attempts to regulate RUOs and the lack by the agency to enforce the regulations outlined in them. Current thoughts and positions of the FDA to regulate will be discussed with special attention to letters written by member of Congress sent to Congressional Committee and a Bill introduced in 2013 which if enacted will change the landscape of RUOs for the future.
Learning Objectives:
Definitions of Research Use Only what are RUOs?
Code of Federal Regulations for Research Use Only Products
Guidance Documents Issued by the FDA
Labeling Requirements for RUOs
Good Manufacturing Practices
Letter from Members of Congress to the Commissioner of the FDA
Congressional Bill regarding FDAs Authority for Research Use Only Products
Who Will Benefit:
Preclinical Researchers
Clinical Researchers
Sales and Marketing Staff Personnel
Laboratory Compliance Office
Biotechnology and Pharmaceutical Professionals
Risk/Compliance Officers in the Clinical fields
Good Manufacturing Practice Managers
For more information, please visit : https://www.complianceglobal.us/product/700526/HaroldThibodeaux/research-use-only-products%E2%80%93the-dos-and-don%E2%80%99ts-pharmaceutical-industry/1
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile:
Harold Thibodeaux is a medical research scientist with in vivo pharmacological experiences in both academia and biopharmaceutical industry. During his prestigious career the focus of Mr. Thibodeauxs research efforts has been on the efficacy of cardiovascular drugs most notably Hypertension, Myocardial Infarction, Focal Ischemia (Stroke), Beyond Advair Pulmonary Research and topical antibiotics. Optimal therapeutic benefits were the goal in all of these projects but cardiovascular safety to provide safer medicines to patients was a priority.
Mr. Thibodeaux transitioned into the pharmaceutical industry when he joined the Cardiovascular Department of Genentech in 1990, as a technical lead with the Second Generation TPA Project Team. Mr. Thibodeaux is a graduate from the College of Charleston with a Bachelor of Science Degree in biology and is a member of The Safety Pharmacology Society.
During his prestigious career, Harold Thibodeauxs ambition and innovation resulted in the successful clinical development of several novel drugs. As a young scientist with Genentech, his contributions to the Second Generation TPA Project were rewarded with the FDA approval of a thrombolytic drug (TNK-TPA or Tenectaplase) that was indicated for Acute Myocardial Infarction. Another notable achievement with the same project team was the approval of Activase Alterplase for Acute Ischemic Stroke Treatment.
As a scientist at Theravance, his innovative models of cardiovascular safety were instrumental in the formation of a Theravance/GlaxoSmithKline Partnership and the development of two clinical candidates for Chronic Obstructive Pulmonary Disease (COPD). Both drugs, BREO Ellipta and ANORO Ellipta, were approved by the FDA and are currently providing therapeutic benefits with patients with COPD. In his role as an investigative scientist with Stiefel, a GlaxoSmithKline Company, Mr. Thibodeaux explored new medical research paths and using his many years of experience in the industry to support project efforts for the reformulations of topical antibiotics, development of models to study acne and writing protocols psoriasis.
During his years of academia and pharmaceutical industry provided an opportunity to authored 23 published articles and discussed his work with poster presentation at major scientific meetings. Harold is proud to have been a medical researcher in both academia and the biopharmaceutical industry and continues to support projects that lead to strategic partnerships that will develop novel drug pipelines for unmet medical needs and present webinars and seminars on drug development to assist pharmaceutical companies achieve their goals.
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Emerging Tobacco Products Update: E-cigarettes FAQS and FDA regulation - By Compliance Global Inc
Overview:
As the use of conventional tobacco products and smoking has decreased in our society, the use of electronic products has soared, especially in the past year.
Why Should You Attend:
Get an update on the current landscape of these products and what we know about safety, health issues, health-effects, smoking effects and other areas of concern including FDA regulation.
Areas Covered in this Webinar:
Following this webinar, participants will have a better understanding of electronic cigarette products, potential health effects and safety of use, information about use as a cessation device, and FDA regulatory updates regarding these products.
Learning Objectives:
Define electronic products and how they work
Identify potential health effects and safety concerns
Explore research around potential use of electronic products for smoking cessation
Explain the inclusion of e-cigarettes, hookah and other tobacco products in the new FDA regulatory decision
Who Will Benefit:
Anyone working with Patients, Employees, or Clients who are using emerging products or are involved in the production and/or marketing of these products
Social Work Organizations
Human Resources Professionals
Employee Assistance Organizations
Health Educator Organizations
Nurses
Counsellors
For more information, please visit : https://www.complianceglobal.us/product/700525/ElizabethStern/emerging-tobacco-products-update-e-cigarettes-faqs-and-fda-regulation/1
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile:
Elizabeth Stern is a licensed master level social worker and certified tobacco treatment specialist with extensive experience as an educator, clinician, and program coordinator. She has over 18 years of experience in the health care field, 15 of those providing tobacco prevention education and smoking cessation.
Her specialties include tobacco prevention and cessation, training and education, community outreach, program development and leadership, counselling, intern and social work supervision, and motivational interviewing.
She has a BS degree in Allied Health from Georgia State University and a MS in Social Work from Columbia University. She is certified as a Tobacco Treatment Specialist by Mayo Clinic and also has certifications in chronic disease self-management and social work core supervision.
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FDA and EMA Global labeling challenges faced in day-to-day operations - By Compliance Global Inc
Overview:
Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as Packet Inserts (PIs), Summaries of Product Characteristics (SmPCs) and Core Data Sheets (CDSs). The large number of product strengths, dosage forms and product presentations results in a large number of labeling records that must be maintained and kept synchronized.
The FDA and EMA are implementing a set of rules for the electronic submission of labeling content. The FDA labelling regulation requires companies to submit XML labeling content in Structured Product Labeling (SPL) format. The EMA labelling regulation requires companies to submit product information documents in QRD-compliant format.
Companies in the regulated life sciences industries must develop and implement systems and processes that will ensure compliance with these standards for their global labeling content. They must also take a longer-term view as to how best to minimize the complexity and cost of doing so.
In this webinar, we will discuss ways to overcome these pharma labelling regulatory challenges and understand how companies in the life sciences industries are doing so through best practices.
Why Should You Attend:
You should attend this webinar if you are responsible for designing, creating or implementing product labels, or maintaining labeling records.
You should also attend if you are responsible for developing and maintaining the systems required for submitting XML labeling content in Structured Product Labeling (SPL) format.
Finally, you should attend if you are responsible for ensuring compliance with labeling requirements for your company.
Areas Covered in this Webinar:
Product labeling background and rationale
Requirements for complying with FDA and EMA requirements for labeling
Converting Word documents into XML and SPL format
The essential labeling materials that are covered
Organizing and maintaining labeling records efficiently and effectively
Inspection of labeling records
Learning Objectives:
Learn what product labeling material is subject to FDA and EMA regulation
Understand the specifics of FDA and EMA regulations for product labeling and how to comply
Learn how to establish and maintain a well-organized system for product labeling, and provide quality assurance for the data included
Learn the importance of developing a consistent system for locating labeling records, and preparing them for regulatory inspection
Learn about best practices and industry standards
Who Will Benefit:
Those responsible for Designing, Creating and Maintaining Product Labels and Labeling Records,
Manufacturing and Quality Assurance Professionals responsible for labeling content, format and management,
IT Professionals involved in the conversion of label content formats for electronic labels,
Quality Assurance Personnel,
Auditors engaged in the internal inspection of labeling records and practices,
Consultants working in the life sciences industries responsible for assisting companies with FDA and EMA compliance for labeling content, format and management
For more information, please visit : https://www.complianceglobal.us/product/700501/CarolynTroiano/fda-and-ema-global-labeling-challenges-faced-in-day-to-day-operations/1
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile:
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDAs electronic record/electronic signature regulation.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the PMI, AITP, RichTech, and volunteers for the PMIs Educational Fund as a project management instructor for non-profit organizations.
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The 2nd Int'l Conference on Clinical and Experimental Hematology (ICCEH 2016)
ICCEH 2016 will be a valuable and important platform for inspiring international and interdisciplinary exchange at the forefront of Clinical and Experimental Hematology.
Conference Speakers
Dr. Abdulaziz M. A. Boker
King Abdulaziz University, Saudi Arabia
Prof. Giancarlo Cortese
U.O. of Radiology, EOSMED, Roma, Italy
Dr. Hatsadee Appassakij
Prince of Songkla University, Thailand
Prof. Limin Chen
Chinese Academy of Medical Sciences, China
Dr. MASOOR KAMALESH
Cardiology Division VA Medical Center, Indianapolis, Indiana University, USA Dr. Med. Bettina Hauswald
Univ.-HNO-Klinik Carl Gustav Carus Dresden, Germany
Dr. Mirajul H. Kazi
National Institute of Cholera & Enteric Diseases (ICMR), Kolkata, India
Prof. VINCENT GEENEN
University of Liege GIGA Research Institute, Liege, Belgium
Prof. Xiang Ma
Ophthalmology Dept. First Affiliated Hospital, Dalian Medical University, China Associate Professor Yunhai Tu
Wenzhou Medical University, China
Prof. Zhuo-Wei Hu
Chinese Academy of Medical Sciences, China
Please register through http://www.engii.org/RegistrationSubmission/default.aspx?ConferenceID=849&utm_source=P2P&utm_campaign=papersubmission&utm_medium=LJ
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Global Addiction Conference
The Global Addiction conference has always been a conference bringing together the foremost experts in the field of addiction, providing a forum for the advancement of addiction understanding and treatment globally. This year, the conference will encompass a broad range of themes, ranging from opioid addiction to non-drug addictions. There will also be a significant portion of the conference devoted to drug policy. The conference is located in a fantastic part of Venice, and will be an enjoyable and educational event for all in the field of addiction. Numerous discounts are available for individual registrations, and we ask group registrations to contact us for registration options.
Urls:
Tickets: https://go.evvnt.com/65164-1
Tickets: https://go.evvnt.com/65164-2
Price
Standard Rate: EUR 450
Discounted Rate: EUR 350
Psychologists - Nurses - Social Workers - etc: EUR 150
Student Rate: EUR 50
1 Day Pass: EUR 200
2 Day Pass: EUR 350
Speakers: Dr Luis Patricio, Dr Jürgen Rehm, Prof Jeffrey Lazarus, Prof Gabriele Fischer, Dr Andrej Kastelic, Dr Mark L Kraus, Dr Stephan Walcher, Prof Heino Stöver, Prof John Dillon, Prof Thanasios Apostolou, Dr Stefan Bourgeois, Dr Gabrielle Welle-Strand, Dr Daniele Zullino, Dr Mori Krantz, Dr Luís Mendão, Dr Liliana Ignjatova, Dr Joy Ruiz-Molleston, Dr Maja Rus
Time: 9:00 am - 2:00 pm
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Aesthetic & Dermatology Laser Operator Training Program
Nurses, beauty therapists and physicians seeking a comprehensive introductory training program pertaining to all laser procedures may enroll in the 90 hour Laser Therapist Training Program. Held in Dubai and with International affiliation through the US National Council on Laser Certification (NCLC), the program gives participants the confidence to perform procedures such as hair removal, skin rejuvenation, resurfacing and tightening.
The training is provided through a sequence of online studies, practical in class hands-on training with live patients in Dubai, and a written examination leading to a US Certification as `Laser Operator`.
The course covers:
Skin and hair biology
Fundamentals of Laser and IPL use and energy concepts
Tissue optics and laser effects
Laser hazards and safety
Laser and IPL hair removal
Light based non-ablative skin rejuvenation
Laser ablative and non-ablative skin rejuvenation
Benign pigmented lesions
Laser tattoo removal
Treatment of vascular lesions
Participants will be required to attend the course for 5 consecutive days from 9am to 6pm in Dubai. Monthly course dates are available to choose from on www.imadubai.com
Time: 9:00 am - 6:00 pm
Price:
From: USD 1795
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3rd Clinical Trials Phase I and Phase IIA Summit
With the rising cost of drugs and increasing regulations, it is essential for organizations to find ways to cut their development costs. Sponsors often focus on achieving regulatory compliance and speeding through early development so they can focus on Phase 3, where they incur the bulk of their development costs. This can cause them to sacrifice on innovative trial design and effective measures for collecting data on the safety and efficacy of a product.
The mission of the 3rd Clinical Trials Phase I and Phase IIA Summit is to provide attendees with the strategies and insight necessary to ensure early stage clinical trials are executed on time and within budget, and to help them explore how to leverage innovative approaches to managing clinical trials from the different therapeutic areas.
URLs:
Booking: https://go.evvnt.com/65126-1
Brochure: https://go.evvnt.com/65126-2
Prices:
Conference - Early Bird Price before September 9th, 2016: USD 1895.00,
Conference - Standard Price after September 9th, 2016: USD 2095.00
Speakers: William Smith, New Orleans Center for Clinical Research, Jim Nissel, Celgene Corporation, George Tonelli, Galmed, Li Zhonggai, Novartis Pharmaceutical, Tatiana Beletskaya, ARENSIA Exploratory Medicine, Tami Crumley, Merck, Mary Westrick, University of Wisconsin, Madison, Howard Greenberg, Janssen (Pharmaceutical Companies of Johnson and Johnson), Laura Vessey, Merck, Amanda Moore, Sage Therapeutics, Richard Clark, Medtronic, Samuel Volchenboum, University of Chicago Graham School, Michelle Combs, Celerion
Time: 4:00 am to 1:00 pm
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Progressing Transitional Care in your Neonatal Unit
This day is designed specifically for Consultant Neonatologists, Neonatal Nurses and Service Managers, Transitional Care Leads, Heads of Midwifery, Midwives and Commissioners of Neonatal Services. Its a case-study led, practical seminar that gives you workable strategies and unique insights into new models of transitional care, including family integrated care and neonatal outreach.
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Safety and Risk Management in the Neonatal Unit
In this interactive workshop, the workshop leaders will give their unique insights into why things go wrong in the neonatal unit. They will lead you through a series of simple, practical strategies and measures that you can put in place to minimise human error and improve safety and risk management without incurring extra cost.
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in-cosmetics Formulation Summit
In terms of what to expect this year, the Formulation Summit will include:
2 days of educational content and networking
New insights and solutions to develop products that truly protect
In-depth case studies, insightful presentations and panel discussions from industry experts
New speakers from Coty, L'Oreal, The Body Shop and Clarins to name a few
Urls:
Inquiries: https://go.evvnt.com/65312-0
Booking: https://go.evvnt.com/65312-2
Brochure: https://go.evvnt.com/65312-3
Time: 09:00 to 17:00
Price:
2 day pass EARLY BIRD: GBP 850,
2 day pass REGULAR RATE: GBP 950,
1 day pass EARLY BIRD: GBP 600,
1 day pass REGULAR RATE: GBP 650,
2 day pass GROUP BOOKING : GBP 750,
1 day pass GROUP BOOKING: GBP 500
Speakers: Clarins, L'Oreal, The Body Shop, King's College London, Neal's Yard Remedies, Coty
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8th Annual Practical Management of Acute Stroke
More than 795,000 strokes occur each year in the US, either new or recurrent, and cause significant morbidity and mortality. Approximately 1 of every 20 deaths is from stroke, making it the fourth leading cause of death in this country, after heart attack, cancer, respiratory disease, and injuries.
Stroke is preventable on many levels, both medical and lifestyle. Increased
knowledge and availability of preventive therapies along with control of
cardiovascular (CV) risk factors has led to a steady decline in the incidence of
stroke along with corresponding mortality declines of nearly 34% from 2003 to
2013. Although control of CV risk factors, especially hypertension, has lowered
incidence of stroke, these reports note that the continued need for greater primary prevention efforts to reduce the lifetime risk, severity, and 30-day mortality following stroke. Improvements in acute stroke treatments, especially early recognition and treatment with tissue plasminogen activator, also have contributed to the declines. Given the significant morbidity and mortality associated with acute strokes, education aimed at improving the knowledge and competence of practitioners to assess, diagnose, and treat this disorder in a
timely manner has the potential to substantially improve outcomes in this large patient population.
Time: 07:00 to 16:30
Price:
Physicians: USD 225,
Residents/Fellows: USD 85,
Non-Physicians: USD 125
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The 4th Conference on Rehabilitation Medicine and Health Care (CRHC 2016)
CRHC 2016 will be a valuable and important platform for inspiring international and interdisciplinary exchange at the forefront of Rehabilitation Medicine and Health Care.
Conference Speakers
Dr. Abdulaziz M. A. Boker
King Abdulaziz University, Saudi Arabia
Prof. Giancarlo Cortese
U.O. of Radiology, EOSMED, Roma, Italy
Dr. Hatsadee Appassakij
Prince of Songkla University, Thailand Prof. Limin Chen
Chinese Academy of Medical Sciences, China
Dr. MASOOR KAMALESH
Cardiology Division VA Medical Center, Indianapolis, Indiana University, USA
Dr. Med. Bettina Hauswald
Univ.-HNO-Klinik Carl Gustav Carus Dresden, Germany Dr. Mirajul H. Kazi
National Institute of Cholera & Enteric Diseases (ICMR), Kolkata, India
Prof. VINCENT GEENEN
University of Liege GIGA Research Institute, Liege, Belgium
Prof. Xiang Ma
Ophthalmology Dept. First Affiliated Hospital, Dalian Medical University, China
Associate Professor Yunhai Tu
Wenzhou Medical University, China
Prof. Zhuo-Wei Hu
Chinese Academy of Medical Sciences, China
Please register through http://www.engii.org/RegistrationSubmission/default.aspx?ConferenceID=848&utm_source=P2P&utm_campaign=papersubmission&utm_medium=LJ
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The 3rd Neurology and Neurosurgery Conference (NeuroConf 2016)
NeuroConf 2016 will be a valuable and important platform for inspiring international and interdisciplinary exchange at the forefront of Neurology and Neurosurgery.
Conference Speakers
Dr. Abdulaziz M. A. Boker
King Abdulaziz University, Saudi Arabia
Prof. Giancarlo Cortese
U.O. of Radiology, EOSMED, Roma, Italy
Dr. Hatsadee Appassakij
Prince of Songkla University, Thailand
Prof. Limin Chen
Chinese Academy of Medical Sciences, China
Dr. MASOOR KAMALESH
Cardiology Division VA Medical Center, Indianapolis, Indiana University, USA
Dr. Med. Bettina Hauswald
Univ.-HNO-Klinik Carl Gustav Carus Dresden, Germany
Dr. Mirajul H. Kazi
National Institute of Cholera & Enteric Diseases (ICMR), Kolkata, India
Prof. VINCENT GEENEN
University of Liege GIGA Research Institute, Liege, Belgium
Prof. Xiang Ma
Ophthalmology Dept. First Affiliated Hospital, Dalian Medical University, China
Associate Professor Yunhai Tu
Wenzhou Medical University, China
Prof. Zhuo-Wei Hu
Chinese Academy of Medical Sciences, China
Please register through http://www.engii.org/RegistrationSubmission/default.aspx?ConferenceID=847&utm_source=P2P&utm_campaign=papersubmission&utm_medium=LJ
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Bio-Identical Hormone Therapy Symposium Dallas
Analyze the medical evidence on BHRT, listen to experts that are actively practicing this specialty and get the information needed to merge BHRT safely into your practice. The traditional medical view of aging is a process with inevitable complications such as cardiovascular disease, diabetes, cancer, dementia and the general steady decline of quality of life.
Learning Objectives:
Review Hormone Replacement for Women
Identify the clinical signs and symptoms of Hypothyroidism
Review Insulin Resistance and the prevention of Type II Diabetes
Assess laboratory tests: Blood, Saliva and Urine
Discuss cortisol levels effect on balanced hormones
Evaluate cortisol levels and circadian rhythm
Evaluate Andropause, Testosterone Treatment and monitoring
Identify adequate HRT and improving sexual function
Understand the effects of growth hormone deficiency
Discuss the benefits of HRT and the Cardiovascular system
Evaluate HRT with neuro-psychopathology in traumatic brain injury
Understand nutritional depletions caused by medications and how hormones are affected
URL:
Booking: https://go.evvnt.com/65284-1
Price:
Early Bird: USD 699
Speakers: Pamela Smith, MD, MPH, MS, Jennifer Landa, MD, FMNM, ABAARM, Rick Rhoads, PharmD, Ron Rothenberg, MD, Mark Gordon, MD, Kris Hart-Pack, NP, RN, FNP, Filomena Trindade, MD, MPH, FMNM, ABAARM
Time: 6:00 pm - 6:00 pm
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