Behind the Scenes at the FDA: Revelations of a Former Statistical Reviewer -- MBC Biostatistics & Data Management Committee

Tue, November 13 12:00 pm – 2:00 pm

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Biostatistics/Data Management

You are invited to join the MBC Biostatistics and Data Management Committee for a presentation on
"Behind the Scenes at the FDA: Revelations of a Former Statistical Reviewer"

When: Tuesday November 13th, 2007

Time: 12:00-2:00 PM

Where: MBC Office, One Cambridge Center, 9th Floor, Cambridge, MA
Topic Overview: Behind the Scenes at the FDA: Revelations of a Former Statistical Reviewer
Learn how to improve collaboration and make your next submission a success from a former FDA Statistical Reviewer and current Sponsor Statistician.

You will be taken behind the scenes at “The Agency” to learn what really happens in the drug development and submission review processes. The authority wielded by Statistical Reviewers in new drug approvals will be revealed. Learn how the FDA Statisticians are organized, their roles and responsibilities, review practices, and thought processes.

Perspectives of FDA and Sponsor Statisticians will be compared and contrasted. Unique challenges faced by each group will be highlighted. Common misconceptions and mythology held by FDA and sponsors will be debunked.

Gain insight into current and future directions for statistical advancement and collaboration between the FDA and industry.

Learning Objectives:

(1) Understanding of the authority, roles, responsibilities, and organizational structure of the FDA Statistical Reviewers.
(2) Awareness of how FDA Statistical Reviewers assesses a new drug application, with an emphasis on tips to make your next submission a success.
(3) Insight into how to partner with the FDA to advance new statistical methods.

Speaker:

AJ Sankoh Ph.D., Senior Director Biometrics, Vertex Pharmaceuticals
(and former FDA Statistical Reviewer)


We look forward to seeing you there!

Lunch will be served.
TO REGISTER:
email your name, title and company to register@massbio.org. Please include "BDM 11/13" in the subject line.
This event is free of charge and open to MBC Member companies and their employees only.

For more information on Membership, contact Lori Gold at lori.gold@massbio.org or 617-674-5149.

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