Global Labeling 2016: Essential Updates on Worldwide Regulations and Guidelines
Short Courses*: September 11
Conference: September 12-13
Short Course 1: From Investigator's Brochure to Worldwide Labeling
Short Course 2: Pharmacovigilance Inspections and the Impact on Labeling
*Short Courses require registration and are an additional fee
Labeling is a critical tool for the safe and effective use of prescription and non-prescription drugs, biologics, and medical devices. The labeling conveys the essential information needed by payers, providers, and patients to make decisions about access, prescription, and use of these products. In an environment of increasingly complex labeling requirements, this conference provides a forum for regulators and industry to update their knowledge of local and global labeling-related policies, and to share processes, tools, and approaches to ensure effective and compliant labeling.
This program has been developed in collaboration with the Regulatory Affairs Community-Labeling Working Group.
View Speaker Biographies and Disclosures
Want to learn more about Global Labeling 2016? You've come to the right site!
Short Course or Primer
To keep you at the forefront.
Steven Bass, PhD President
Bass Biopharm Consulting Group LLC, United States
Su-Yueh Lin Sr. Labeling Consultant, Regulatory Affairs
Barbara J. Fanelli, MSc Associate Adjunct Professor
Temple University School of Pharmacy, United States
A. Leander Fontaine, MD President
Pharmiceutics, LLC., United States
Barbara Lachmann, MD Sole Proprietor
Barbara Lachmann Labeling Consulting, Germany
Megann Looker Executive Director, Head of Global Labeling
Jazz Pharmaceuticals, United Kingdom
Rie Matsui, RPh Senior Director, International Labeling APAC
Pfizer R&D Japan G.K., Japan
Gerrit Nijveldt, MSc Global Labeling Consultant
Opus Regulatory Inc., United States
Junko Sato, PhD Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan