Invitation to
PDA Discussion Meeting
Organized by Raphy Bar

Review of the new draft ICH Q11 Guide
By Dr. Alex Weisman,
Vice president R&D, Chemagis

Current Practices and Regulatory Expectations
for API and DMF

By Dr. Ori Lerman
Chief Chemist, Institute for Standardization and Control of Pharmaceuticals, Ministry of Health

Discussion and Comments
Speakers and
Karen Ginsbury (PCI)
Raphy Bar (BR Consulting)

Get ready for the NEW ICH Q11!

Tuesday, July 26, 15:30h – 18:30h
Lev Hakongressim, Weizmann Science Park, Ness Ziona

At last, it sees light! After the ICH Q8 guide which is dedicated to the drug product, the newly issued draft ICH Q11 deals with drug substances (pharmaceuticals and biopharmaceuticals).
If you are a chemist, engineer, regulatory personnel or QA personnel, you should get ready to this guide in order to know how to:

  • incorporate the principles of quality by design in manufacturing process development of a drug substance.
  • develop a control strategy
  • compile a file application in CTD format
  • implement continuous verification to a manufacturing process of a drug substance

This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in certain CTD sections. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance.
All attendants are invited to make comments to this new draft. The collected comments will be forwarded to Global PDA for consideration and possible inclusion in the final package of comments that will be submitted to EMA.
Disclaimer: Unexpected changes in the program may occur and Israel PDA Chapter board will not be held for liable.

for map please click here

International PDA members - 80 NIS
Non members - 160 NIS

Registration is mandatory, please register here

Organized & Produced by
Bioforum - Applied Knowledge Center
Lev Hakongressim, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071



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