Regulatory/GMP Compliance, Europe

Revision Process for Global/National Pharmacopoeias

December 15, 2019

The revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world are described.

Revision Process for Global/National Pharmacopoeias (eBook)

December 15, 2019

This article describes the revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world.

Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions

December 15, 2019

An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.

Detailed Consideration of Global and National Pharmacopoeias

December 15, 2019

An understanding of global and national pharmacopoeias is crucial to understanding change processes and access to different markets.

Industry Pharmacopoeia Surveillance Process in Detail

December 15, 2019

The process used to monitor and participate in pharmacopoeial changes is described.

Regulatory and Standard Setting Organizations

December 15, 2019

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Resources, Guidelines, and Guidance Documents

December 15, 2019

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions (eBook)

December 15, 2019

An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.

Italian Biopharm Requests Type A FDA Meeting to Discuss Statistical Plan

December 12, 2019

Newron Pharmaceuticals has received communications from the United States Food and Drug Administration (FDA) suggesting it discusses its proposed statistical plan in a Type A meeting.

Galderma Receives Breakthrough Therapy Designation for Nemolizumab

December 12, 2019

Galderma, a Swiss-based dermatology company that the United States Food and Drug Administration (FDA) has granted breakthrough therapy designation to its investigational therapy, nemolizumab.