RAPS Convergence 2022

Phoenix, Arizona

Phoenix Convention Center

September 11 - September 13, 2022

Phoenix, Arizona | Phoenix Convention Center |

RAPS Convergence is your regulatory meeting place to connect and interact with peers, health authorities and notified bodies across the healthcare products industry.

Compared to the complexity of a new drug application, generic medicines should be a relatively simple application. However, in pharmaceuticals sometimes it is the small things which trip us up. Even specialist generic companies can experience difficulties in securing an approval for their generic application.

This session will show the full spectrum of generics in Europe and their respective legal basis. It will walk through straightforward slam dunk applications; to applications where there are difficulties in demonstrating bioequivalence; to more complex applications involving multiple CMC changes compated to an originator product, such as a different dosage form. It will also discuss the EU legal basis for these abridged applications and cover regulatory difficulties such as correctly identifying a suitable reference product for your application.

Michael Craig.pngJoin Parexel's Michael Craig, VP Technical to hear him present on "EU Generics - When Does a Simple Procedure Become Complex?" on Monday, September 12 at 4:35pm MST in room W106C.  In that session, he will:

Describe the legal basis and critical EMA guidance for generics in Europe

Explain the importance of biowaivers and how they are applied correctly in different circumstances

Verbalize the common major objections with EU generic applications and how they can be avoided

 

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