ALEXANDRIA, Va. -- The American Association of Pharmaceutical Scientists (AAPS) will present the AAPS Workshop on Successful U.S. and EU Registrations: Chemistry and Manufacturing Controls (CMC) Trials and Tribulations, May 3-5, 2000 at the Crystal Gateway Marriott in Arlington, Va.
"This will be a great opportunity for scientists in the pharmaceutical industry and in various government agencies to exchange information on what is working well and what needs to be improved in the CMC area," said Christopher Riley, Ph.D., DuPont Pharmaceuticals. "This unique workshop will give equal time to regulators from Europe and the U.S. and to industrial scientists from the innovator and generic companies."
The workshop will bring together pharmaceutical scientists and regulators from the U.S. and Europe to discuss factors that have resulted in successful drug product registrations from the perspective of Chemistry and Manufacturing Controls. The workshop will also explore what issues have caused problems in this regard, as well as contrasting International Conference on Harmonization (ICH) Quality Guidelines with "total requirements." Topics of focus include drug substances and drug product specifications, test methods and validation, and stability data.
Although there will be formal presentations from the four participating groups (EU, FDA, innovator and generic companies), the main focus of the workshop will be on the break-out groups where participants will have an opportunity to share their experiences and develop recommendations for change.
For more information on this workshop, including a complete preliminary program, registration fees, and accommodations, visit AAPS Online at http://www.aaps.org/edumeet/ tribulations/index.html.
AAPS is a professional, scientific society of more than 10,000 members employed in academia, industry, government and other research institutes worldwid
Contact: Debbie Mierke
American Association of Pharmaceutical Scientists