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Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

Global key initiatives towards harmonization, convergence and collaborative efforts in advancing the development and accessibility of advanced therapy medicinal products (ATMPs) will be explored, with a special focus on supporting MICs.

Learning Objectives

Outline global efforts on collaboration and harmonization initiatives for ATMPs; Identify and discuss efforts to build regulatory capacity, provide technical assistance, and facilitate access to ATMPs in middle-income countries (MICs); Discuss strategies for achieving convergence and harmonization for ATMPs.

Chair

Maria Antonieta Tony Roman, MPharm

Speaker

Global Efforts to Build Regulatory Capacity and Facilitate Access to ATMPs in Middle-Income Countries
Sarah Adam

Collaborative and Harmonization Initiatives Advancing the Development and Accessibility of Advanced Therapy Medicinal Products
Dianliang Lei

Panelist
Yasuhiro Kishioka, PhD

ANVISA Perspective
Renata Miranda Parca, AHIP


Speakers
avatar for Sarah Adam

Sarah Adam

Associate Director, Regulatory Affairs, IFPMA, Switzerland
Sarah Adam coordinates IFPMA activities in the Regulatory field focussing on policy, regulatory system strengthening and harmonisation. She also leads Regulatory Science Policy for Africa. Prior, Sarah worked for many years, for ICH, supporting the harmonisation of ICH technical Guidelines... Read More →
avatar for Yasuhiro Kishioka

Yasuhiro Kishioka

Reviewer Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of gene therapy products and the quality of biotechnological/biological products. Since joining PMDA in 2008, Dr. Kishioka has been involved... Read More →
DL

Dianliang Lei

Scientist of Technology, Standard and Norm, World Health Organization (WHO), Switzerland
RP

Renata Parca

Health regulatory specialist, ANVISA, Brazil
I hold a degree in Biology from the University of Brasília, where I also completed my master’s degree. I work as a health specialist at Anvisa since 2005, in the office of blood, tissues, cells, and advanced therapy medicinal products.
avatar for Maria Antonieta Roman

Maria Antonieta Roman

Head Regulatory Policy Emerging Markets LATAM, Novartis, Mexico
Degree in Pharmacy, Master of Science (pharmacy) UNAM; Diploma in Clinical development and regulatory affairs, Universidad Anahuac; diploma in public health by the Swiss School of Public Health. 32 years of experience in various areas in the Pharmaceutical industry like R&D, quality... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

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