Meet the FDA!
PDA SEMINAR
Organized by
Dr. Raphy Bar
On

With the participation of a special guest Speaker from the FDA
Dr. David Jacobson-Kram

Ph.D., D.A.B.T. Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration

July 15-16, 2008, Kfar Hamaccabiah, Ramat Gan

PROGRAM FOR PDA SEMINAR
All presentations will be given in English

NEW AND GENERIC DRUGS - July 15, 2008

Duration Topic Speaker 09.15 – 09:30 Opening remarks President, Israel Chapter of PDA Dr. Raphy Bar BR Consulting 09:30 – 10:00 Regulation of impurities in drug substances and products Dr. David Jacobson-Kram FDA 10:00 – 10:30 Evaluation of impurities in API batches: a perspective of a regulator Dr. Ori Lerman MOH 10.30 – 11.00 Detection of impurities in drugs by LC-MS and LC-MS /MS Dr. Ran Rosen Agentek 11.00 – 11:30 Coffee Break 11:30 – 12.00 Minimizing process-related impurities in API synthesis: a Quality By Design approach Dr. Lior Zelikovich Chemagis Ltd. 12.00 – 12:30 Detection and quantitation of an unknown impurity in stability samples: A case study Dr. Yoram Cohen Taro 12.30 – 13:00 Solid impurities: Detection and quantitation Dr. Judith Aronhime Teva 13:00– 14:00 Lunch 14:00– 14.30 Leachables as impurities: Analytical methodologies Dr. Raphy Bar BR Consulting 14:30 – 15:00 Safety qualification of impurities in biopharmaceutical drugs Dr. David Jacobson-Kram FDA 15.00– 15:45 Coffee Break 15:45 – 17.00 Meet The Regulators: Questions and Answers Moderated by: Karen Ginsbury Dr. David Jacobson-Kram FDA (USA) Dr. Mimi Kaplan MOH (Israel)

INVESTIGATIONAL DRUGS - July 16, 2008

Duration Topic Speaker 09.15 – 09:30 Opening remarks President, Israel Chapter of PDA Dr. Raphy Bar BR Consulting 9:30 - 10:00 Selection of clinical drug candidates: From a hit to a lead Dr. Iris Alroy Pharmos 10:00 – 10:30 Overview of exploratory INDs Dr. David Jacobson-Kram FDA 10.30 – 11:15 Coffee Break 11.15 – 11.45 GMPs in drug development Phases 1 and 2 Karen Ginsbury PCI SYMPOSIUM on Drug safety Evaluation: From preclinical studies to first human doses 11:45 – 12.15 Preclinical safety testing of drugs Dr. David Jacobson-Kram FDA 12.15 – 12:45 Regulation of genotoxic and carcinogenic impurities 12:45 – 13:45 Lunch 13:45 – 14:15 Calculating clinical start dose from toxicology studies Dr. David Jacobson-Kram FDA 14.15 – 15:00 Coffee Break 15:00 – 16.00 Meet The Regulator: Questions and Answers Moderated by: Raphy Bar Dr. David Jacobson-Kram FDA (USA) * Please see the website for any last minute changes * All presentations will be given in English * You may register for each day separately * The binder of the handouts may not include all slides presented, due to limitations imposed on some speakers.

David Jacobson-Kram, Ph.D, DABT
David Jacobson-Kram received his Ph.D. in embryology from the University of Connecticut in 1976. He joined BioReliance in 1988. Currently, he serves as the Associate Director of Pharmacology and Toxicology in FDA’s Office of New Drugs. Over the past twenty five years he has served as principal and co-principal investigator on several N.I.H. grants and government contracts. Since 1976 Dr. Jacobson-Kram has published over 80 abstracts, 57 original articles in peer reviewed journals, and 30 review articles or book chapters. Dr. Jacobson-Kram has served as council member, treasurer and chairman of the Genetic Toxicology Association, executive council member to the Environmental Mutagen Society, Editor of Cell Biology and Toxicology, President of National Capital Area Chapter of the SOT and as a member of N.I.H. special study sections. In 1996 he became a Diplomate of the American Board of Toxicology (DABT).

Participation:

Non-members:	* Members:
1150 NIS	950 NIS	One Day July 15 or 16
1950 NIS	1750 NIS	Two Days  July 15 and 16

DISCOUNT:
For every 5 participants registered per company, one may attend free of charge.

* Please note that the cost for members is only for paid members of the International PDA.