Upcoming Events - 2016 GPhA Workshop
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Upcoming Events – 2016 GPhA Workshop
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Events

Bethesda North Marriott Hotel and Conference Center
North Bethesda,
May 17 – 18, 2016


 

GPhA is pleased to announce the 2016 two-day CMC workshop devoted solely for the purpose of fostering in-depth discussions on the FDA’s CMC expectations for ANDAs, enhanced regulatory filing requirements, and many other important topics as CMC moves firmly into the Office of Pharmaceutical Quality (OPQ).

Attend this interactive workshop, where experts from the FDA, industry and academia will provide you with the opportunity to learn the most up-to-date information regarding CMC regulatory quality requirements, and how generic applicants can more effectively meet the challenges of first cycle approval.

• OPQ Update
• Clinical relevance – dissolution specification
• Transparency and Communication
• Lifecycle Management of Drug Products and Regulatory Commitment or Established Conditions (ICH Q12)
• Risk Based Review
• API (ICH Q11)
• Stability Update
• Quality Metrics
• Compliance Update

GPhA Member: $1,725.00
Nonmember: $2,070.00

Cancellations must be received in writing either faxed to 202-249-7105 or emailed to aagee@gphaonline.org by Tuesday, May 3, and confirmed by GPhA. All cancellations are subject to a $300 processing fee. No refunds after May 3, 2016.

GPhA is offering sponsorship opportunities that include significant exposure to the workshop attendees throughout the program. For more information, or contact Jennifer Nguyen at jnguyen@gphaonline.org.

Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852

Reservations must be made directly with the Bethesda North Marriott Hotel and Conference Center by calling 1-800-228-9290. Please refer to the meeting name: “GPhA CMC Workshop” to obtain the preferred rate. Only a limited number of preferred rate rooms are available. The preferred rate cut off date is April 25, 2016. After this date or after the preferred rate rooms are sold out, rooms are subject to hotel rates and availability.



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