Course Overview
Developed and delivered in partnership with Opus Regulatory, PERI presents a one-of-a-kind comprehensive labeling education symposium exploring both fundamental labeling skills and specialized concepts, including current events and new regulatory initiatives. Throughout the two-day program, global experts from big pharma and small pharma will lead several dynamic sessions; faculty for this program also include current and former FDA representatives, academics, and consultant presenters.
The program features a blend of interactive presentations, roundtable discussions, case studies, and collaborative sessions, each meticulously planned to provide the best education experience for symposium participants. Each session includes dedicated discussion time for participants to ask questions directly of the faculty speakers and engage in meaningful dialogue.
This in-person experience has a limited capacity to foster a classroom-style learning environment and encourage networking between participants and faculty leaders.
Event Details
Course Dates: October 17 – 18, 2023
Course Location:
Kimpton Hotel Monaco Washington, DC
700 F Street NW
Washington, DC 20004
202-628-7177
Regular Course Rate: $1,945.00 USD
Please review the ticket prices carefully, as there are several options and discounts available for attending the symposium. A valid credit card is required for registration.
Benefits of Attendance
- Gain a deeper understanding of the importance of the label in the product life cycle
- Collect new ideas and strategies to support your labeling practice
- Learn best practices (and lessons learned) from real-world examples through case study scenarios
- Expand your knowledge of individual label sections and the clinical development implications on key sections
- Network with labeling and regulatory experts throughout the interactive symposium
Educational Objectives
Upon completion of the symposium, participants should be able to:
- Identify fundamental labeling principles regarding CCDS US and EU Labeling
- Discuss key regulatory principles promulgated by the FDA and EMA
- Develop a strategy for using the label as development driver
- Employ core labeling principles and downstream activities to ROW labeling and compliance activities
Course Location
The course will be held at the following hotel in downtown Washington, DC:
Washington, DC 20004 USA
+1 202-628-7177
Confirmed Faculty
Laurie Burke, MPH
Founder of LORA Group, LLC
Keynote Speaker
Shaily Arora, PharmD
Executive Regulatory Science Director, TDR
AstraZeneca
Julie Batal, MBA, JD
VP, Regulatory Labeling, Advertising & Promotion, Compliance & Operations
bluebird bio
Vishal Bhatnagar, MD
Associate Director, Patient Outcomes
Oncology Center of Excellence
US Food & Drug Administration
Karen Ciprero
Senior Director, Global Labeling
Merck & Co., Inc.
Nina El-Badry, M.S., RAC (US, EU)
Senior Regulatory Advisor
BARDA
Department of Health and
Human Services (HHS)
Mike Fahmy
Executive Director
Otsuka Pharmaceutical Development & Commercialization
Leander Fontaine, MD
Owner
pharmiceutics, LLC
Ari Gnanasakthy
Principal Scientist, Patient-Centered Outcome Assessment
RTI Health Solutions
Ilona Große-Michaelis
Senior Medical Dictionary Expert
Bayer AG
Colleen McGraw
Senior Director, Regulatory Affairs Labeling
Moderna
Donald Patrick, PhD
Professor Emeritus, Health Systems and Population Health
University of Washington School of Public Health
Gerrit-Jan Nijveldt
Principal Labeling Consultant
Opus Regulatory
Omar Perez, PhD, RAC
Head of Medical Diagnostics,
US Medical Affairs, Oncology
AstraZeneca
Peter Petrochenko, PhD, RAC
Associate Director, CMC Regulatory Affairs
Regeneron
Reena Philip, PhD
Associate Director, Biomarkers and Precision Oncology
Oncology Center of Excellence
US Food & Drug Administration
William Pierce, PharmD, MPH, BCPS
Associate Director, Oncology Labeling
Oncology Center of Excellence
US Food & Drug Administration
Jody L Roth, PMP, RAC
Vice President,
Global Regulatory Affairs
Immunovant
Vijay Sammeta, MD, MBA
Senior Director Global Labeling Strategy
Sanofi
Joe Sison
Labeling Director
Merck & Co., Inc.
Kelly Treonze
Executive Director, Global Labeling Therapeutic Areas
Merck & Co., Inc.
Mary Beth Wilusz
Head, Regulatory Labeling Operations and Compliance
Daiichi Sankyo, Inc
Key Topics
- Patient-Focused Outcome Measurements (FDA Roadmap)
- Labeling to Support Small and Large Pharma
- Populating the Adverse Reaction Section in Labeling
- CIOMS MedDRA Grouping
- Labeling During a Public Health Emergency
- Device Labeling-Instructions for Use: Development and Use in Labeling
- Oncology Labeling Initiatives
- Patient Reported Outcomes
- Secondary and Exploratory Endpoints
- Developmental Labeling as Driver
- Labeling Compliance & Audit Readiness
Who Should Attend
Pharmaceutical professionals from all levels of experience, including but not limited to:
- Regulatory Affairs and Strategy
- Labeling Strategists
- Labeling Operations
- Labeling Compliance
- Pharmacovigilance
- Medical Writers
- Clinical Safety
- Clinical Trial Professionals
Symposium Agenda
PERI Facilitator
Lauren Kirk
Education Director
571-490-8409
lkirk@peri.org
Pre-Symposium Workshops
Pre-symposium workshops have been developed as a companion to the symposium and are ideal for new labeling or regulatory professionals looking to build a solid foundation. Scheduled for Monday, October 16, the day before the symposium, participants may participate in one or both of the half-day workshops.
The morning session focuses on company core data sheets (CCDS), the CCDS during drug development, and the impact of a CCDS. Also discussed will be rest-of-world labeling deviations, and how to run successful label working group meetings. The afternoon session explores the US and EU developmental labeling process, including the target product profile (TPP), and key details about the labeling process in the US and EU.