Overview

April 23: Short Courses
April 24-25: Conference

Labeling is a critical tool for the safe and effective use of prescription drugs, biologics, and medical devices. Its purpose is to convey the essential information needed by providers, patients, and payers to make decisions about product access, prescription, and use. Today’s environment of increasingly complex labeling regulations and guidances is especially challenging for products marketed in multiple regions, which demand worldwide consistency of prescribing and patient information. This Conference provides a forum for regulators and industry to update their knowledge of local and global labeling-related policies and to examine the impact of changes on regulatory compliance. Through expert panels and interactive discussions, participants will share approaches, processes, and tools to ensure effective labeling that meets regulatory expectations.

On-Demand Complimentary Webinar

What is Hot in Global Labeling?
This webinar will provide highlights of draft and recently approved regulations for awareness of potential impact to your global operations. This includes the revisions to the EU GVP Module IX guideline, SPL in Canada, updating of labeling in Japan and device regulations in the EU.
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Featured Topics

Global Labeling Issues and Updates
Labeling Role
Pharmacovigilance Risk Assessment
Packaging Issues
Combination Products
Biosimilars
Patient Leaflet
Plain Language Labeling
Patient Medication Information (PMI)
International Strategic Plan

Featured

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Who should attend?

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

Learning objectives

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

Discuss new labeling-related developments and regulations (e.g., Canada, EU, Japan, Asia, Latin America, Middle East, Africa, and US)
Describe the impact of proposed changes to regional and global labeling requirements and implications for labeling practice and processes
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 lifecycle practices
Assess the advantages and limitations of various labeling processes and document management systems commonly used in companies
Describe global labeling compliance expectations and best practices

Short Course or Primer

To keep you at the forefront.

Apr 23, 2018

Course 1:

EU Inspections and Audit Readiness Plans

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Apr 23, 2018

Course 2:

Writing Good Core Data Sheets and Supporting Documentation – Performing Rational Deviation Management

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Apr 23, 2018

Course 1:

EU Inspections and Audit Readiness Plans

Learn more

Apr 23, 2018

Course 2:

Writing Good Core Data Sheets and Supporting Documentation – Performing Rational Deviation Management

Learn more

Program Committee

Steven Bass, PhD President
Bass Biopharm Consulting Group LLC, United States
Su-Yueh Lin Sr. Labeling Consultant, Regulatory Affairs
SYL Regulatory Consulting, Taiwan
Mark Collins, PhD, MBA Principal Consultant
Opus Regulatory, United States
Barbara J. Fanelli, MSc Associate Adjunct Professor
Temple University School of Pharmacy, United States
A. Leander Fontaine, MD President
Pharmiceutics, LLC., United States
Paula Hudson, RPh, RAC Director, Global Labeling
Eli Lilly and Company, 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