[EQ] CDER Forum for International Drug Regulatory Authorities

CDER Forum for International Drug Regulatory Authorities

October 5 - 9, 2009, Silver Spring, MD

International Programs -Center for Drug Evaluation and Research (CDER)

U.S. Food and Drug Administration

Website:  http://www.fda.gov/Drugs/NewsEvents/ucm167039.htm

 

 

We will place a greater emphasis on the regulatory review process and have added a panel of review discipline experts that will discuss a product review that is posted on Center for Drug Evaluation and Research  CDER’s DRUGS@FDA website. 

 

We will also have in depth presentations on drug product quality (both small molecule and biologics) and the GMP inspection process. 

 

The Center for Drug Evaluation and Research CDER values the Forum as a mechanism to meet Drug Regulatory Authorities from around the world.

 

Please forward this email to your colleagues who would benefit from our regulatory training. 

 

Please direct any questions to our CDER Forum mailbox:  cderforum@fda.hhs.gov .

Justina A. Molzon, M.S. Pharm, J.D. Associate Director for International Programs
Center for Drug Evaluation and Research (CDER)

U.S. Food and Drug Administration

 

 

Monday 05 October, 2009

Overview of Processes and Structure

 

8:30  – 9:00	REGISTRATION
9:00 – 10:00	CAPT Justina Molzon, M.S., Pharm, J.D. Associate Director International Programs CDER FDA	Welcome and Introduction	Overview of the program and Participant Introductions
10:00 – 10:30	Walter Batts Deputy Director Office of International Programs Office of the Commissioner FDA	FDA’s International Program	Overview of FDA’s International Programs, including Organization, Activities and Foreign Offices
10:30 -10:45	BREAK
10:45 – 11:15	CDR Mary Kremzner, Pharm.D. Associate Director Div of Drug Information CDER FDA	Role of CDER	Overview of the Process and Structure of CDER FDA including the Orphan drugs
11:15 – 12:15	CAPT Justina Molzon, M.S., Pharm, J.D. Associate Director International Programs CDER FDA	ICH and the Common Technical Document	The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
12:15 – 1:30	LUNCH on Your Own
	OVERVIEW OF APPLICATIONS AND REVIEWS
1:30 – 2:15	Nancy Derr, M.A. Policy Analyst Write Editor Office of Regulatory Policy CDER/FDA	Good Guidance Practices and  CDER’s Manual of Policies and Procedures	In 2000, GGPs became the law. This presentation reviews the development and implementation of good guidance practices at FDA.
2:15 – 3:00	Beth Duvall-Miller, B.S. Chem. Team Leader Regulatory Affairs Office of New Drugs CDER FDA	Drug Development in the 21st Century: The Role of OND	Phases of Drug Development OND’s organizational structure OND’s role in the review process 21st Century Review Process OND’s interactions with regulated industry OND-led programs and initiatives
3:00 – 3:15	BREAK
3:15 – 4:00	Jayne Peterson Advisors and Consultants CDER FDA	Advisory Committees	Role of Advisory Committees in the drug review and approval process
4:00 – 4:30	CDR Rita Shapiro, M.A., D.P.T. Office of Executive Programs Div. of Training & Development CDER FDA	Skill Building for Reviewers in CDER	The steps CDER takes to ensure appropriate training is provided to all reviewers at entry level as well as advanced updates.
4:30 – 5:00	Monica Unger, M.L.S. Web Project Manger Div. of Information Services Office of Training and Communication, CDER FDA	CDER Public Transparency through WWW	An overview of CDER webpage on the FDA website and  information available to the public.

 

Tuesday 06 October, 2009

Review of New Molecular Entities

 

9:00 – 10:15	Ann Farrell, M.D. Office of New Drugs Div. of Drug Oncology Products CDER FDA	Drug Review Process	An overview of safety and efficacy of  new drugs
10:15 – 10:30	BREAK
10:30 – 12:00	Renmeet Grewal, Pharm. D. – Project Management/Moderator Audrey Gassman, M.D. – Med. Officer Angelica Dorantes, Ph.D. Daphne Ty Lin, Ph.D. – Statistician Amy L. Ellis, Ph.D. – Pharm. Tox. Cindy Kortepeter, Pharm. D. – Safety		Regulatory Drug Review: A panel of CDER Review Disciplines will discuss the drug review process
12:30 – 1:00	GROUP PHOTO
1:00 – 2:00	LUNCH on Your Own
2:00 – 2:45	Norman R. Schmuff, Ph.D. Branch Chief Office of New Drug Quality Assessment Office of Pharmaceutical Science CDER FDA	Quality Review (Chemistry)	A review of drug law and the quality controls with chemistry and manufacturing perspectives.
2:45 – 3:30	Patrick Swann, Ph.D. Deputy Director Div. of Monoclonal Antibodies Office of Biotechnology Products CDER FDA	Quality Review (Biologics)	An overview of biologics quality review and regulation at CDER
3:30 – 4:15	Elizabeth Durmowicz, M.D. Team Leader Pediatric and Maternal Health Office of New Drugs CDER FDA	Specialty Reviews (Pediatrics)	History of drug development in pediatric patients, pediatric legislation and outcomes of legislation
4:15-4:30	BREAK
4:30 – 5:30	CAPT Justina Molzon, M.S., Pharm, J.D. Associate Director International Programs CDER FDA	Labeling Overview	A label for the drug as a result of the review process

 

Wednesday 07 October, 2009

Review of Over the Counter and Generic Drugs

 

9:00 – 9:45	Leah Christl, Ph.D. Associate Director for Regulatory Affairs Office of Non-prescription Products CDER FDA	Regulation of Over-The-Counter (OTC) Drugs	How the OTCs are regulated and how the labeling of the OTCs is regulated to protect public health.
9:45 – 10:30	CDR Spencer Salis, Pharm. D. Regulatory Operations Officer (OTC) Div. of New Drugs and Labeling Compliance Office of Compliance CDER FDA	Overview of the OTC Drugs Team- Compliance Issues	An overview of OTC drugs enforcement and current OTC priorities
10:30 – 10:45	BREAK
10:45 – 12:15	Edward Sherwood Management Analyst Office of Pharmaceutical Science CDER FDA	Overview of the Generic Drug Process	Discussion on when generic drugs are eligible to enter the market and how CDER ensures that they are safe, effective and quality products
12:15 – 1:30	LUNCH on Your Own
1:30 – 3:00	Suhas Patankar, Ph.D. Division of Chemistry Office of Generic Drugs Office of Pharmaceutical Sciences CDER FDA	ANDA Review Process CMC Perspective	Discussion will cover assessment of critical points addressed in Chemistry Manufacturing and Controls review of ANDAs, and Office of Generic Drug's new initiatives
3:00 – 3:15	BREAK
3:15 – 4:45	Leah N. Williamson, Ph.D. Kuldeep R. Dhariwal, Ph.D. Division of Bioequivalence Office of Generic Drugs CDER FDA	Bioequivalence Recommendations	Discussion will provide an Overview of Bioequivalence Testing in the U.S. for Generic Drugs

 

Thursday 08 October, 2009

Compliance

 

9:00 – 9:30	CAPT Jason J.Y. Woo, M.D. Associate Director of Scientific and Medical Affairs Office of Compliance, CDER, FDA	Compliance Overview	Overview of the Drug Lifecycle and role of Compliance in ensuring Drug Product Safety and Integrity, as well as impact of Globalization on drug regulation.
	SCIENTIFIC INVESTIGATIONS
9:30 –10:15	Connie Lewin, MD Medical Officer Division of Scientific Investigations, Office of Compliance, CDER, FDA	Role of CDER in Bioresearch Monitoring Program	Description of FDA's Bioresearch Monitoring Program as carried out by CDER and how CDER assesses sponsor and clinical investigator compliance with pertinent regulations.
10:15 – 11:00	Jacqueline O'Shaughnessy, Ph.D. Pharmacologist Division of Scientific Investigations, Office of Compliance, CDER, FDA	Bioequivalence and Good Laboratory Practice	Overview of BE and GLP inspectional activities and their impact on the review process
11:00 – 11:15	BREAK
11:15 – 12:45	PANEL:  DIVISION OF NEW DRUGS and LABELING,  OFFICE of COMPLIANCE, CDER, FDA
	Kathleen R. Anderson, Pharm. D. Deputy Director   Elizabeth Miller, Pharm. D. Pharmacist - Acting Team Leader Internet and Health Fraud Team   Karen Rothschild, Esq. Regulatory Counsel New Drugs and Labeling Team   Huascar Batista, M.P.H Team Leader, Imports Exports Team,   Sudha Shukla, Pharm. D. Pharmacist, Compounding Team	Overview     Internet and Health Fraud     New Drugs and Labeling     Imports Exports     Pharmacy Compounding	Overview of how FDA addresses and takes enforcement action against drugs marketed without FDA approval, including drugs sold via the internet, fraudulent drugs, prescription drugs, imported drugs, and compounded drugs.
12:45-1:00             DNDLC Q & A
1:00 – 2:00                                                                                       LUNCH on Your Own
2:00 – 3:30                                 DIV. of Manufacturing and Product Quality,  Office of Compliance
	Monica Caphart, M.S.   Colleen Hoyt       Yumi Hiramine       Israel Santiago     Douglas Campbell, B.S.	Case Management   Manufacturer Assessment & Pre-approval   International Compliance   Recalls, Shortages & Certificates   Inspectional Process	An overview of the roles and responsibilities of the FDA/CDER New, Generic and the Biotech Manufacturing Teams. Overview of the roles/responsibilities of FDA/CDER International Compliance Team An overview of the Recalls, Shortages and Certificates Branch and its functions   Quality System Approach to Inspections. Examples of records to review during inspections
3:30 –3:45	DMPQ:  Qs and As

 

Friday 09 October, 2009

Postmarketing

 

9:00 – 10:00	Gerald Dal Pan, M.D. M.H.S. Director Office of Surveillance and Epidemiology CDER FDA	Overview of Drug Safety	An overview of drug safety with emphasis on public health
10:00-10:15	BREAK
10:15- 11:30	John Coburn and Suzanne Barone, Ph.D. Div. of Compliance Risk Management and Surveillance	Compliance Risk Management and Surveillance	Drug Registration and Listing, Surveillance of Adverse Event Reporting, Drug Quality Reporting, and Risk Evaluation and Mitigation Strategies
11:30 – 1:00	LUNCH on Your Own
1:00 – 2:00	Gerald Dal Pan, M.D. M.H.S. Director Office of Surveillance and Epidemiology CDER FDA	Overview of Drug Safety	How the drug safety is monitored and enforced in the market
2:00 – 2:15	BREAK
2:15 – 2:45	Barbara Chong, Pharm. D., BCPS Team Leader Div. of Drug Marketing, Advertising, and Communications Office of Medical Policy CDER FDA	Drug Marketing, Advertising, and Communications	An overview of the regulations pertaining to prescription drug promotion and recent enforcement actions
2:45 – 3:15	Denise Toyer, Pharm. D. Div. of Medication Errors Prevention and Analysis Office of Surveillance and Epidemiology CDER FDA	Medication Errors	Medication errors reporting and subsequent management, review of MED-WATCH
3:15 – 4:30	OPEN FORUM Discussion by all Participants, Program Evaluation, Awarding Of Certificates and Review of the Contents on the Flash Drive à Farewell and future plans

 

 

Lou Valdez, MSM  Associate Commissioner for International Programs
Office of the Commissioner  U.S. Food and Drug Administration
Parklawn Building Room 15A-55
(301) 827-4480 Office  (301) 335-5562 BB

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