EMA Archives - Page 2 of 3 - Xtalks

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A Rare Behind-the-Scenes Look at CHMP Meetings – Challenges, Opportunities, and the One Shot You Have at Winning

November 23, 2020

A Comparison of FDA, EMA & PMDA Regulatory Guidance for In Vitro Drug-Drug Interaction (DDI) Assessments

September 10, 2020

Life Science News

Researchers Call For ‘Radical Innovation’ in Cancer Drug Development and Review

February 4, 2020

Risk Management Plans: GVP Module V Revision 2 and Its Local Impact in the EU

February 06, 2020

Winning from the Beginning: Best Practices to Increase Your Chances for Successful CHMP Meetings

November 14, 2019

Study: How Dependable Are Surrogate Endpoints?

September 13, 2019

Winning From the Beginning: Best Practices to Increase Your Chances for First-Pass Approvals in Key Markets

October 23, 2019

An Overview & Comparison of US and EU Pediatric Drug Development Regulations and Processes

Life Science News

How a No-Deal Brexit Could Impact the Flow of Pharmaceuticals in the UK

December 13, 2018

Who Will Replace Ian Hudson as CEO of UK’s MHRA?

November 22, 2018

How Will EMA’s Third Phase of Its Brexit Preparedness Plan Impact the Pharma Industry?

October 12, 2018

Sarepta Therapeutics Gets Clinical Hold Lifted by FDA While CHMP Rejects Exondys 51 Application

September 25, 2018

Preparing for Brexit: EMA Limits Activities and Pharma Companies Build Up Drug Surplus UK

August 24, 2018

Amgen and Allergan Hopeful that Herceptin Biosimilar Approval Will Be Around the Corner

Post-Brexit UK Wants to Stay in EMA. What Will the EU Say?

Business & Finance News

EMA’s Temporary Amsterdam Headquarters Will Be Half the Size of Current London Site

January 31, 2018

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