קטגוריה: PDA - העמותה לקידום המדע והטכנולוגיה הפרמצבטית בישראל , כנסים
PDA Meeting: Impurities in Drugs

 

העמותה לקידום וטכנולוגיה הפרמצבטית בישראל - PDA
תאריך: 15, 16 יולי 2008
מיקום הקורס:  כפר המכביה, רמת גן
שפת הקורס: אנגלית
משך הפעילות: 2 ימי לימודים מלאים
שעות: 08:30-17:00
נקודות זכות: 0
מק''ט: P08003
 

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.

Registration is mandatory, please register here

 

 

Organized & Produced by
Bioforum Applied Knowledge Center


Bioforum - Applied Knowledge Center
Lev Hakongressim, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
E-mail:
bioforum@bezeqint.net
site: www.bioforum.org.il

 

 
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