Courses target Chinese drug makers

Industry group ISPE is partnering with the China Centre for Pharmaceutical International Exchange (CCPIE) to bring training courses tailored to the needs of the Chinese pharmaceutical industry. Industry leader Gordon Farquharson will be presenting courses on sterile drug manufacturing facilities and pharmaceutical water systems.

The Sterile Drug Manufacturing Facilities: Applying ISPE Baseline Guide, FDA, EU/PICS and WHO Principles to Design and Operation course will review ISPE's sterile manufacturing facilities baseline guide, the FDA's 2004 Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice, and the March 2009 implementation of Annex 1 of the EU GMP, according to an announcement. The course is intended to help participants understand the key requirements and GMPs for sterile product manufacturing facilities.

In the second course, Pharmaceutical Water Systems: Regulation, Purification, Distribution and Validation, participants will review the principles of design and operation of water systems used in pharmaceutical manufacturing, including the regulatory requirements, concepts, and principles for systems used to generate, store and distribute both compendial and non-compendial waters.

- read the course descriptions


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.