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Ms. Huo Xiumin, formerly responsible for drug product review at CDE (Center for Drug Evaluation, NMPA), shared her understanding of Technical Guideline …. She highlighted that compatibility studies are the responsibility of pharmaceutical companies, and that they should work closely with packaging components suppliers. Ms. Lynn Yao, Scientific Affairs Manager at West, presented on the overseas regulatory landscape for extractables and leachables, focusing on regulatory requirements, safety risk assessments, general approaches and case studies. The other presenters comprised experts from domestic pharmaceutical packaging materials manufacturers, pharmaceutical companies, and government agencies.
The West Scientific Affairs and Technical Customer Support (TCS) teams constantly monitor the regulatory landscape worldwide, in order to help customers navigate the regulations and select components that meet the unique needs of their drug products. For more information, contact an Account Manager or TCS representative.