Overview

Parallel Scientific Advice: FDA-EMA Parallel Scientific Advice (PSA) Program

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Event Agenda

 

DATE: Wednesday, 20 July 2022

TIME:    6:00 – 6:05 PM   Welcome and Announcements

               6:05 – 7:05 PM   Program Presentation

               7:05 – 7:30 PM   Q & A

LOCATION:  This is an ONLINE event on zoom virtual platform       

Program Details

 

The Parallel Scientific Advice (PSA) Program is a program shared by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) that provides a mechanism for experts from both the agencies to concurrently engage in scientific discourse with sponsors on key issues during the development phase of new medicinal products.

Speaker Biography

Valmik Doshi, MS is a US Regulatory Lead for Neurocrine’s clinical stage schizophrenia disease compounds. In his role, he lead as well participate in the development and execution of US and Global regulatory strategies in conjunction with Global Regulatory Lead (GRL) and cross-functional team members. Prior to joining Neurocrine, he spent ~7+ years in regulatory affairs at Alkermes, Takeda, Infinity Pharmaceuticals and worked in Central Nervous System (CNS) and Oncology therapeutic areas. He has a BS in Pharmacy and MS in Drug Regulatory Affairs and Health Policies from Massachusetts College of Pharmacy and Health Sciences, Boston.

 

Contact

[email protected]

 

Pricing – Online – Registration (June 20, 2022 – July 19, 2022)

Registrant Type Price
Member $10.00
Lifetime $10.00
Non-Member $15.00

 OCRA Member

 

$10.00

 

Cancellation Policy

 

There will be no refunds for cancellations.