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Tuesday, June 27 • 8:30am - 9:30am
#209: International Regulatory Convergence and Collaboration

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-23-559-L04-P; CME 1.00; RN 1.00

Session participants will understand how international regulatory collaboration leads to convergence between regulators and enables faster international patient access. They will be able to understand different models of collaboration and their impact on convergence of international regulatory systems. Participants will hear case examples from Africa, Asia Pacific and LATAM regions to identify success factors and lessons learned that contribute to the successful use of international collaboration pathways for their international regulatory strategy and how it impacts on patient access.

Learning Objectives

Describe how international regulatory collaboration leads to convergence between regulators and enables faster international patient access; Describe different models of collaboration and their impact on convergence of international regulatory systems; Identify through case examples from Africa, Asia Pacific and LATAM regions to identify success factors and lessons learned.

Chair

Angelika Joos, MPharm

Speaker

ANVISA Path to Regulatory Convergence and Support for Other Countries
Leonardo Dutra Rosa

Engagement of Regulatory Authorities in Latin America on Global Convergence Initiatives
Ana Pineda Zavaleta, MSc

EMA Support for Africa
Martin Harvey Allchurch, LLM

Effective Development Relies on Global Standards
Charbel Haber, PhD, MBA, MPH

Panelist
David Mukanga, PhD, MPH


Speakers
avatar for Angelika Joos

Angelika Joos

Executive Director, Global Regulatory Policy, MSD, Belgium
Angelika Joos is a trained pharmacist. She is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional... Read More →
avatar for Leonardo Dutra Rosa

Leonardo Dutra Rosa

Head of the International Affairs Office, ANVISA, Brazil
Head of Anvisa's International Affairs Office since March 2020, is a career diplomat who served at diplomatic missions in Lima (Peru) and Montevideo (Uruguay). At the headquarters of the Ministry of Foreign Affairs, he held, among others, the position of deputy head of the MERCOSUR... Read More →
avatar for Ana Pineda

Ana Pineda

International Regulatory Analyst, LAO, OGPS, OPLIA, OC, FDA, United States
Ms. Pineda joined the U.S. FDA office in Mexico on March, 2013. She has a BSc on Chemistry, Pharmacology and Biology from the UNAM and a MSc on Toxicology from the CINVESTAV/IPN. She started her professional career in the pharmaceutical industry in the production area. In 2001 she... Read More →
avatar for Martin Harvey Allchurch

Martin Harvey Allchurch

Head of International Affairs, European Medicines Agency, Netherlands
Martin Harvey is Head of International Affairs at the European Medicines Agency (EMA), EU. He first joined the EMA legal team after serving as a European affairs consultant in Brussels. He headed the Office of the Executive Director, served as Head of Communication, and then moved... Read More →
avatar for Charbel Haber

Charbel Haber

Senior Vice President, Head of Regulatory Affairs, Moderna, United States
Charbel Haber joined Moderna in April 2020 as the Senior Vice-President and Head of Global Regulatory Science. In this role, Charbel was responsible of building the global regulatory function to support Moderna’s pipeline including the development and registration of Moderna COVID-19... Read More →
avatar for David Mukanga

David Mukanga

Deputy Director, Africa Regulatory Systems, Bill & Melinda Gates Foundation, United States
Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports... Read More →

Tuesday June 27, 2023 8:30am - 9:30am EDT
Room 153 AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session