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Webinar On FDA’s Biosimilar (Generic Biologics) Process

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(Free Press Release) This web presentation presents an overview of FDA’s requirements for approval/marketing of a Generic Biologic (Biosimilar) in the USA Scheduled On : Thursday, May 8, 2014 at 13:00 Hrs

Webinar On FDA’s Biosimilar (Generic Biologics) Process


      

This web presentation presents an overview of FDA’s requirements for approval/marketing of a Generic Biologic (Biosimilar) in the USA. This webinar covers the Biosimilar product testing requirements (clinical and nonclinical) and the Biosimilar approval pathway. The webinar also reviews the Regulatory/Scientific/Quality principles involved along with the 3 FDA Biosimilar guideline documents. The FDA Step-wise Approach and the FDA Totality of Evidence concepts will also be discuss.

Areas Covered in the Session :

BPCI Act

Define the terms Biosimilar and Interchangeability

FDA's Stepwise Approach

FDA's Totality-of-the - Evidence Approach

The Biosimilar Approval pathway

 

Who Will Benefit:

Regulatory Affairs Personnel

Quality Personnel

Clinical Personnel

Research Personnel

Manufacturing Personnel

Legal Personnel

Auditors

Clinical Research Associates

Personnel who require an understanding of the FDA Biosimilar process

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

 

$ 299

For bookings contact us:

Complaince Trainings

5939 Candlebrook Ct,
Mississauga, ON L5V 2V6,
Canada
Customer Support : 416-915-4458

Email : This e-mail address is being protected from spambots. You need JavaScript enabled to view it

For more information visit

FDA Biosimilar process




Webinar On FDA’s Biosimilar (Generic Biologics) Process

Source: Press Release

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