Regulatory Submissions, Information, and Document Management Forum

Bethesda North Marriott Hotel and Conference Center

Paediatric Regulation Ten Years On

By Christina Bucci-Rechtweg, MD

The paediatric population is primarily healthy, rendering paediatric drug development research challenging due to the limited...

Regulatory Aspects in Pharmacovigilance and Practical Examples

Holiday Inn London - Regent's Park

First Regional ICH Training on CMC

By Silke Vogel, Hozanna Ngoh

Newly formed with a purpose to more strategically oversee ICH training efforts, the ICH Training Subcommittee recently...

1st Regional Conference on Regulatory Harmonisation

Sofitel Casablanca Tour Blanche

The Company Core Data Sheet in Light of XML-Authoring and IDMP Master Data Implementation

By Stefan Hock, MDRA, PhD

Labeling decisions for core labeling and/or local labeling capture the outcome of all discussions on the product statements...

DIA EUROPE 2018

Congress Center Basel

A Comparison of PMDA and EMA Consultations for Regulatory and Scientific Matters in Drugs and Regenerative Medicine Products

By Hideyuki Kondo, MBA; Toshiki Sugita, PhD; Naoko Ida, PhD; Hiroko Fukushima, MPH, MPharm; Naoyuki Yasuda, MS

The Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA) have provided a wide range of...

Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America, and Other Emerging Markets

Mercure Paris La Défense Grande Arche

Pediatric Medicine Development An Overview and Comparison of Regulatory Processes in the European Union and United States

By Dobromir Penkov, MD; Paolo Tomasi, MD; Irmgard Eichler, MD; Dianne Murphy, MD; Lynne P. Yao, MD; Jean Temeck, MD

Pediatric legislation in the US and the EU is driving pediatric product development on an international scale. To facilitate...

Using Off-Label Communications to Responsibly Advance the Public Health

By Peter J. Pitts, BA

The debate over off-label communications doesn’t begin or end with the Caronia or Amarin decisions. It’s a continuing...

DIA 2018 Global Annual Meeting

Boston Convention and Exhibition Center