Course Overview
Developed and delivered in partnership with Opus Regulatory, PERI is proud to offer the a one-of-a-kind comprehensive labeling education symposium in 2024! This engaging program explores both fundamental labeling skills and specialized concepts, including current events and new regulatory initiatives. Throughout the two-day program, global experts from big pharma, small pharma, academia and regulatory agencies 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, 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 8 – 9, 2024
• Pre-Symposium Workshop: October 7
Course Location:
Kimpton Hotel Monaco Washington, DC
700 F Street NW
Washington, DC 20004
202-628-7177
Regular Course Rate: $1,945.00 USD
Early Course Rate: $1,745.00 USD
Early Deadline: August 30, 2024
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 7, the day before the symposium, sessions review in-depth adverse reactions, establishing labeling governance, and synergy between CCDS/CCSI and local labeling.
The workshop concludes with an interactive case study workshop with practical applications of the strategy and knowledge reviewed during the comprehensive presentations.
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
- Establishing Labeling
Governance - Patient Reported Outcomes
- Real World Evidence
- End-to-End Labeling
- Deviation Management
- Labeling Perspective on TPL
- Using the Label as a Driver
- FDA’s Real Time Oncology
Review - Companion Diagnostics
- Challenging Populations:
Pediatrics, Rare Disease - Oncology Safety Labeling:
Grouping CTCAE, SMQS - Instructions for Use: Human
Factors Testing, Who Owns IFU? - Labeling Negotiations
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