Best Practices and Application of GMPs for Small Molecule Drugs in Early Development
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An IQ sponsored workshop on phase appropriate strategies for Drug Product Manufacturing Drug Substance and Drug Product Analytical Methods, Stability and Specifications
In early development, the manufacturing process is not yet fully defined and the analytical methods are not yet fully validated. Therefore, the quality system implemented during early phase should take into account the likely process changes, in-process adjustments, specification changes, scope of the stability study and continuous development of the analytical methods as intrinsic to the work being performed prior to the determination of the final process and validation of the analytical methods during later stages of development.
- Provide a broader public forum for further discussion of the application of GMPs in Early Development as outlined in the position papers published in Pharmaceutical Technology in 2012
- Build alignment with health authorities and industrial CMC stakeholders (QA, CMC development scientists, regulatory CMC) on the best practices outlined in the position papers.
- Discuss the impact of applying these concepts in early development for different therapeutic areas/disease states.
- Publish workshop proceedings integrating feedback based upon the discussions.
Plenary Session followed by consecutive tracks covering each of the four key areas DP Manufacturing Analytical Methods for DS & DP Specifications for DS & DP Stability for DS & DP
Who should attend?
Industry scientists and professionals involved in CMC development e.g. QA, CMC-regulatory, analytical and formulation development scientists, Supply Chain personnel CMC Regulatory scientists and professionals from FDA, EMA, Health Canada, etc.
Attendance is limited to the first 100 registrants. Registration fees are as follows:
- $450/IQ Member Company Attendee;
- $550/Non-IQ Member Company Attendee;
- $200/regulatory participant
WORKSHOP ORGANIZING COMMITTEE
John Skoug, AbbVie
Jackson Pellett, Genentech
Don Chambers, Merck
Pete Yehl, Genentech
Mark D. Trone, Takeda-Cambridge (US)
Eleni Dokou, Vertex
Mike Coutant, Pfizer
Jamie McElvain, Kythera Biopharma
Mike Szulc, Biogen-Idec
Chan Li, Boehringer-Ingelheim
Brent Kleintop, BMS
Steve Colgan, Pfizer
Henry Rasmussen, Vertex
Tony Mazzeo, BMS
Zhanna Yuabova, Boehringer-Ingelheim
Jessica Tan, Amgen
Dennis Joiner, Merck
Bruce Acken, Merck
Mike Kress, Merck
Pete Yehl, Genentech
Dennis O’Connor, Boehringer-Ingelheim
Rob McKean, Teva
Richard Creekmore, AstraZeneca