Overview
Short Course : April 1
Short Course : April 1
Conference: April 4-5
DIA is offering a virtual conference for the Global Labeling Conference that allows you to view all the session recordings from the comfort of your own home/office. Can't make all the sessions live? You will receive access to the On Demand library with your registration for 2 months post-conference.
DIA’s Global Labeling Conference is designed for professionals in medical product labeling and related disciplines as they work to develop and manage clear and accurate labeling information for the safe and effective use of prescription drugs, biologics, and medical devices. The efforts of these professionals are key to providing essential information needed by providers, patients, and payers to make decisions about product access, prescription, and use. Influences such as digital technology, patient centricity, evolving product classes, and changing regulations require the use of informed, systematic approaches throughout the labeling cycle to ensure the development and availability of current, compliant information in all regions where products are marketed.
This conference provides a forum for exchange among regulators and industry peers to update their knowledge of key local and global labeling policies and to examine the impact of changes on regulatory compliance. Most importantly, through interactive discussions with expert panels and peer-to-peer exchange, participants will share approaches, processes, and tools to ensure the availability of effective labeling content meeting the needs of patients, consumers, and prescribers.
Featured
Short Course or Primer
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Apr 01, 2022
Global Labeling – The Basics of Core Datasheet
Learn more -
Apr 01, 2022
Beyond the Basics of the Core Data Sheet: A Practical Approach to Regional Considerations
Learn more
Who should attend?
Professionals from biopharmaceutical and device companies, regulatory authorities, CROs, and consulting agencies involved in:
- Labeling
- Regulatory Affairs/Drug Review and Approval Process
- Clinical Safety/Pharmacovigilance
- Pharmacoepidemiology
- Medical Affairs and Communications
- Medical Writing
- Clinical Research and Development
- Product Research and Development Alliances
- Quality Control/Quality Assurance
- Marketing/Advertising/Promotion
Learning objectives
- Identify the key labeling requirements in major markets
- Discuss the concept of digital labeling and forms it may take in making product information available to patients and prescribers
- Examine the regulations supporting drug prescribing information in Latin America and the Caribbean and identify the changes in
- UK MHRA regulations as a result of Brexit – both those that are new and still in transition
- Explain how labeling operations governance groups can be used to monitor submission and implementation metrics and oversee and influence labeling compliance
- Explain the value of labeling during drug development from a global and local perspective
- Describe the opportunities and challenges of patient-centric drug labeling for all stakeholders
- Describe the different types of non-traditional data and the possibility and pros/cons for inclusion in labeling or promotional materials
- Describe the latest information regarding the current regulations and guidance for combination product and medical device labeling in the US and EU
Program Committee
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Su-Yueh Lin • Sr. Labeling Consultant, Regulatory Affairs
Taiwan -
Kathy Salazar, MA, MBA • Head, Global Labeling Implementation, Global Labeling COE
Janssen Research & Development/Johnson & Johnson, United States -
Deborah Bebbington • Head Global Labeling
Bayer Plc, United Kingdom -
Theresa Brunone, MA, MS • Head-Labelling Compliance and Implementation, Global Labeling
GlaxoSmithKline, United States -
Lauren Brunke, PharmD, RPh • Senior Director – GRA-NA Global Labeling Department (GoLD)
Eli Lilly and Co, United States -
Megann Looker • Executive Director, Head of Global Labeling
Jazz Pharmaceuticals, United Kingdom -
Rie Matsui, RPh • Senior Director, Regional Labeling Head for APAC
Pfizer Inc, Japan -
Gerrit Nijveldt, MSc • Global Labeling Consultant
Opus Regulatory Inc., United States -
Hayley Parker, PhD, MSc • Vice President Regulatory Affairs
PepGen, United States -
Steven Bass, PhD • President
Bass Biopharm Consulting Group LLC, United States -
A. Leander Fontaine, MD • President
Pharmiceutics, LLC., United States
Contact us
Registration Questions?
Preconference Short Courses
Short Course 1: Global Labeling – The Basics of Core Datasheet
Additional Information
Live Meeting PoliciesDiscover DIA’s Live In-Person and Live Virtual Events
DIA’s Global Labeling Conference Infographic
