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CHALLENGES IN POSTMARKING STUDIES OF BIOLOGICAL DRUGS IN THE ERA OF BIOSIMILAR Sponsored types 2019 MIDYEAR MEETINGREGISTRATION FORMAL 69, 2019 | RADISSON BLU ES. HOTEL | ROME, ITALY Use one form

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What is challenges in post-marketing studies?

Challenges in post-marketing studies refer to the difficulties or obstacles faced when conducting studies after a product has been approved and marketed.

Who is required to file challenges in post-marketing studies?

The sponsors or researchers conducting the post-marketing studies are required to file challenges.

How to fill out challenges in post-marketing studies?

Challenges in post-marketing studies can be filled out by detailing the specific obstacles encountered, the impact on the study, and any proposed solutions.

What is the purpose of challenges in post-marketing studies?

The purpose of challenges in post-marketing studies is to ensure transparency, document obstacles faced during the study, and address them appropriately.

What information must be reported on challenges in post-marketing studies?

Information reported on challenges in post-marketing studies should include the specific obstacles faced, their impact on the study, and any proposed solutions.

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