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Wednesday, June 19 • 4:30pm - 5:30pm
#372: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence: An Industry and Regulatory Agency Experience

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-671-L04-P; CME 1.00; RN 1.00

This forum will discuss regulatory activities and technology to enable global convergence and reliance for post-approval changes (PAC). Diverse panelists will share examples of efficient collaboration and information exchange to reduce the PAC process cycle times.

Learning Objectives

Recognize the importance of global collaboration to support sovereign decision making; Discuss how building in reliance practices into cloud-based solutions could accelerate the post-approve changes (PAC) process globally; Explain how cloud solutions support transparency, trust, regulatory convergence, and information exchange, and collaboration to increase patient access to therapies.

Chair

Dominique Lagrave, PharmD

Speaker

Panelist
Samvel Azatyan, MD, PhD

Panelist
David Mukanga, PhD, MPH

Panelist
Susanne Ausborn, PhD

Panelist
Cynthia Ban


Speakers
avatar for Dominique Lagrave

Dominique Lagrave

Senior Vice President of Regulatory Innovation, Accumulus Synergy, United States
Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →
avatar for Susanne Ausborn

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland
Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
avatar for Samvel Azatyan

Samvel Azatyan

Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland
Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →
avatar for Cynthia Ban

Cynthia Ban

Global Head, Regulatory Affairs CMC, Vaccines, Sanofi, Canada
Cynthia Ban is the Global Head Regulatory CMC & Devices for Vaccines at Sanofi. Senior Global Leader in the pharmaceutical industry specializing in Regulatory Affairs. Worked for small biotech and large multinational companies. Led and developed teams across multiple geographies and... 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 →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Forum