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 through leaders, 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 7 – 8, 2025
• Pre-Symposium Workshop: October 6
Course Location:
Kimpton Hotel Monaco
700 F Street NW
Washington, DC 20004
202-628-7177
Regular Course Rate: $1,975.00 USD
Early Course Rate: $1,775.00 USD
Early Deadline: August 22, 2025
Government/non-profit rates and group discounts available!
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.
Pre-Symposium Workshop
The pre-symposium workshop has been developed as a companion to the symposium and is ideal for new labeling or regulatory professionals looking to build a solid foundation.
Scheduled for Monday, October 6, this workshop will address development labeling (from TPL to submission), core labeling (CCDS), and development labeling in the EU through presentations, guided discussions, and case studies.
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
Key Topics
- Labeling Collaborations with Regulatory, Ad Promo, and more
- Unique Labeling Case Studies: Rare Diseases, Cell and Gene Therapy, Cross-Labeling for Combination Products (Oncology), Radiopharmaceuticals, Biosimilars
- Industry Human Factors Engineering and Case Studies
- US Patient Labeling Strategies
- EU Patient Labeling Strategies
- Patient-Reported Outcomes
- Clinical Studies: Impact to Labeling – Building US and EU Clinical Studies
- Clinical Case Study – Exploring One Product Across Markets
- Industry Labeling Deviations – Impact to Core
- Developmental Labeling
- Addressing Challenges with Safety Sections: DDIs, ADRs
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