Name: #271: Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products
Start: 2025-06-17T16:00:00-0400
End: 2025-06-17T17:00:00-0400

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

147AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-603-L04-P; CME 1.00; RN 1.00

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
Kowid Ho, PharmD

Panelist
Julia Djonova

Panelist
Dianliang Lei

Panelist
Caroline Pothet, PharmD, RPh, RAC

Panelist
Yasuhiro Kishioka, PhD

Panelist
Renata Miranda Parca, AHIP

Speakers

Julia Djonova

Head Division ATMP, Swissmedic, Switzerland

Kowid Ho

Pharma Technical Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland

Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for >10 years. He was previously a quality assessor for biological products at Agence nationale de sécurité du médicament et des produits santé (ANSM... Read More →

Yasuhiro Kishioka

Review 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 regenerative medical products (gene/cell therapy products). Since joining PMDA in 2008, Dr. Kishioka has been involved in various international... Read More →

Dianliang Lei

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

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.

Caroline Pothet

Head of advanced therapies and haemato-oncology, European Medicines Agency, Netherlands

Caroline Pothet is head of the office for advanced therapies and haemato-oncology at the European Medicines Agency. Caroline joined EMA in 2020; prior to this, Caroline worked in the Industry for 20 years in a variety of sectors such as regulatory policy, regulatory science and drug... Read More →

Maria Antonieta Roman

Head Regulatory Policy LaCan, 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
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulatory Collaboration, Regulatory Convergence and Harmonization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Collaboration ,Regulatory Convergence and Harmonization
Tags Session

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