概要

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

特集トピック

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参加対象

Professionals from biopharmaceutical and device companies, regulatory authorities, CROs, and consulting agencies involved in:

Labeling
Clinical Safety/Pharmacovigilance
Pharmacoepidemiology
Regulatory Affairs/Drug review and approval process
Medical Affairs and Communications
Medical Writing
Clinical Research and Development
Product research and development alliances
Quality Control/Quality Assurance

学習目的

At the conclusion of this conference, participants should be able to:

Discuss new labeling-related developments in Canada, European Union, Japan, Asia, and the US
Compare and contrast packaging regulations/guidance among global regions including the US, EU, Asia, and Canada
Describe the new US initiatives with structured product labeling
Describe the impact of proposed changes to regional and global patient labeling requirements
Analyze the impact of current and proposed global and region-specific labeling policies for combination products, biosimilars, and generic drugs on labeling development and product life cycle practices
Discuss how labeling groups can work effectively and increase their impact within a variety of organization structures

Short Course or Primer

To keep you at the forefront.

2016年9月11日 (日)

Course 1:

From Investigator's Brochure to Worldwide Labeling

2016年9月11日 (日)

Course 2:

Pharmacovigilance Inspections and the Impact on Labeling

2016年9月11日 (日)

Course 1:

From Investigator's Brochure to Worldwide Labeling

2016年9月11日 (日)

Course 2:

Pharmacovigilance Inspections and the Impact on Labeling

プログラム委員会

Steven Bass, PhD President
Bass Biopharm Consulting Group LLC, United States
Su-Yueh Lin Sr. Labeling Consultant, Regulatory Affairs
SYL Regulatory Consulting, Taiwan
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, Regional Labeling Head for APAC, International Labeling
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