Events

Bethesda North Marriott Hotel & Conference Center

North Bethesda, MD

June 2 - 3, 2010

Sponsorship Form | Agenda | Tip Sheet

GPhA is pleased to announce the GPhA/FDA 2010 ANDA Basics Workshop

The GPhA/FDA ANDA Basics Workshop has become a “must attend” event for the generic pharmaceutical industry.

This two-day workshop addresses the fundamentals of preparing and submitting abbreviated new drug applications. Learn directly from FDA’s Office of Generic Drugs (OGD) staff members who are responsible for reviewing and approving your company’s applications.

OGD and industry expert instructors will focus on each of the critical sections of an ANDA, including regulatory, labeling, chemistry, manufacturing and controls, and bioequivalence. The industry experts also will share 'real world' experience related to the preparation and submission of ANDAs.

Key Learning Objectives Include:

• Organization and content of an ANDA
• Fundamentals of preparation and submission
• Key laws and regulations impacting ANDAs
• Technical information submitted in support of an ANDA
• Best practices for meeting OGD expectations

Who Should Attend

This workshop is recommended for those who would like to learn more about abbreviated new drug applications (ANDA) requirements, or would like to refresh their knowledge about ANDA content and the review process.

Continuing Education

NEW: Registered pharmacists in the United States wishing to receive pharmacy continuing education credit must preregister at the University of Wisconsin website to receive credit. Only pharmacists who have registered by June 1 and have completed the brief pre-assessment instrument will be eligible to receive credit.

To register for CE credit and complete the pre-assessment instrument go to http://ce.pharmacy.wisc.edu/courseinfo/10-052.

Extension Services in Pharmacy at the University of Wisconsin-Madison School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program has been designated as an application-based program and is approved for 12 hours (1.2 CEUs) of pharmacy continuing education credit. Pharmacists will be required to complete a pre- and post-survey regarding educational objectives and a program evaluation. Statements of credit will be mailed within 30 days of receipt of materials documenting participation of this program. The Universal Program Number: 073-999-10-052-L04-P.

IMPORTANT NOTE: The rules regarding ACPE accreditation have changed. Attendees to the 2010 ANDA Basics workshop who wish to earn ACPE credits must also register online prior to the event dates. Click here for online registration for ACPE credits.

Hotel Information:

Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road
North Bethesda, MD 20852
(301) 822-9200

Reservations must be made directly with the hotel by calling 800-228-9290.

Fees:

GPhA Member: $1495
Nonmember: $1895

Sponsorship:

GPhA is offering sponsorship opportunities that include significant exposure to the workshop attendees throughout the program. For more information, contact Katie Dysart, kdysart@gphaonline.org.

Cancellations:

Cancellations must be received in writing either faxed to 202-249-7105 or emailed to jnguyen@gphaonline.org by May 19, and confirmed by GPhA. All cancellations are subject to a $300 processing fee. No refunds after May 19, 2010.

GPhA thanks our ANDA Basics Workshop sponsor to date:

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