Events

Bethesda North Marriott Hotel and Conference Center

North Bethesda, MD

May 22 - 23, 2012

Agenda │ Sponsorship Opportunities │ Tip Sheet

The 2012 GPhA/FDA CMC Workshop is now sold out! Please join us for the 2012 Fall Tehnical Conference in October. Click here for more information.

GPhA is pleased to announce its partnership with FDA in hosting this two-day workshop devoted solely for the purpose of fostering in-depth discussion between FDA and the generic industry on the expectations for regulatory filing and review of stability for drug products.

Attend this interactive workshop and have the opportunity to meet FDA attendees including OGD staff directly responsible for reviewing your company’s regulatory filings.

Key Conference Objectives Include:

• To discuss FDA OGD's new review process and filing expectations of Type II DMF for drug substance.

• To detail FDA OGD's expectations for regulatory filing and review of stability for drug products.

• To describe the use of risk assessment, DOEs, and other approaches in the determination of critical quality attributes, critical material attributes, and critical process parameters and their relationships.

• To report the FDA OGD's progress in revising QbR questions to incorporate quality target product profile, product and process design and understanding, and control strategy.

Meeting Registration

GPhA Member: $1550
Nonmember: $1895

Cancellations:

Cancellations must be received in writing either faxed to 202-249-7105 or emailed to jnguyen@gphaonline.org by April 22, and confirmed by GPhA. All cancellations are subject to a $300 processing fee. No refunds after May 10, 2012.

Hotel Information

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

To reserve a room at the Bethesda North Marriott Hotel & Conference Center, call 1-800-228-9290. To receive GPhA’s preferred rate, mention the “GPhA Meeting.” A limited number of rooms are available at the preferred rate until Monday, April 30, 2012. After these rooms sell out, or after April 30, rooms are subject to standard hotel rates and availability. GPhA’s preferred rate is only available to registered attendees.

Sponsorship:

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

GPhA Thanks the Sponsors of the 2012 GPhA/FDA CMC Workshop to Date:

Host Sponsors:
     

Reception Sponsor:

Publication Partners: