Loading…
← Back to schedule
#440: Harnessing International Regulatory Reliance and Collaboration to Accelerate Innovation and Patient Access to Medicines
Monday June 15, 2026 2:30pm - 3:30pm EDT
115C
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-534-L04-P; CME 1.00; RN 1.00

Sponsors are increasingly leveraging regulatory collaboration and reliance approaches. In this Forum, international regulatory and industry experts will review ongoing pilot projects and discuss future opportunities.

Learning Objectives

Discuss Industry experience with reliance initiatives; Explain ICMRA and ICH efforts to facilitate a pharmaceutical quality knowledge management capability; Identify benefits and challenges for expanding global regulatory reliance and collaboration; Outline how cloud-based platforms and harmonized regional requirements can strengthen reliance.

Chair

Amanda Roache, MS

Speaker

Reflections on ICMRA Pilots and Opportunities for International Regulatory Collaboration
Sarah Pope Miksinski, PHD

Panelist
Evdokia Korakianiti, PHD, MSC

FDA Reflection on Experiences with International Regulatory Collaboration and Opportunities
Ashley Boam, MS

Industry Experiences with Regulatory Reliance and Collaboration Initiatives
Joann M Parker, MS, RPH


Speakers
avatar for Ashley Boam

Ashley Boam

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
Sarah Pope Miksinski has been with Gilead since July 2023 and is currently an Executive Director in CMC Regulatory Affairs. She represents Gilead in various external capacities – including serving on PhRMA’s Global Quality and Manufacturing Committee, serving as chair of ISPE’s... Read More →
JP

Joann Parker

Vice President of Regulatory CMC, Pfizer, United States
avatar for Amanda Roache

Amanda Roache

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Amanda Roache, MPP, is Deputy Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Tweet Share

Get help with the event

Contact event planner Event login
View support guides Find upcoming events
Create an event you'd love to attend!
Explore why organizers choose Sched • Success stories
Event App • Event scheduling • Event registration • Event ticketing • Sched forms • Call for papers • Badges • Conferences
© 2026. SCHED LLC - All rights reserved - Helping events since 2008
Meeting Planning Software • Privacy • Terms
Share Modal

Share this link via

Or copy link