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Wednesday, June 21 • 4:00pm - 5:15pm
#371: Global and Regional Collaboration Initiatives: Challenges, Opportunities, and Case Studies

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Several global and regional collaboration initiatives are in place in order to foster access to medicines, specifically for patients in developing countries. The main objectives of these initiatives are to accelerate approval processes based on regulatory collaboration and reliance. As an example, supported by the World Health Organisation (WHO), National Medicines Regulatory Authorities (NMRAs) can inform their own assessment report process by drawing on the assessment performed by a reference authority, so called Stringent Regulatory Authority (SRA). Based on selected case studies, this session will examine collaboration initiatives and review the opportunities and challenges from authority and industry perspective.

Learning Objectives

Discuss the complexity of regulatory convergence; Identify the progress being made through case studies.

Chair

Joseph C. Scheeren, PharmD

Speaker

Regulatory Collaboration Initiatives in Order to Accelerate Approval Process in Developing Countries
Petra Doerr, PharmD, PhD, RPh

Collaborative Registration Procedure: A Tool to Accelerate Regulatory Approvals - Case Studies from Africa
Mercè Caturla Goñi

A Novel Tool to Support Optimized Regulatory Strategies for Emerging Markets: A Case Study
Rajneesh Taneja, PhD



Moderators
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →

Speakers
avatar for Petra Doerr

Petra Doerr

Deputy Executive Director, Swissmedic
Since January 2014 Head of Communication and Networking and Deputy Executive Director at Swissmedic, Swiss Agency for Therapeutic Products. Oversees the international activities with other agencies and international organisations. Member of the ICH Management Committee and of the... Read More →
avatar for Mercè Caturla Goñi

Mercè Caturla Goñi

Global Access Regulatory Leader, Regulatory Policy (Africa and WHO), Janssen Pharmaceutical Companies of Johnson & Johnson
Mercè Caturla is the Global Access and Regulatory Policy (Africa and WHO) Lead at Janssen. She is primarily responsible for leading and overseeing coherent and unified regulatory strategies to make medicines accessible in resource limited settings, Africa in particular. She part... Read More →
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →
avatar for Rajneesh Taneja

Rajneesh Taneja

Senior Director, Pharmaceutical Product Development, TB Alliance
Raj is the Sr. Director for Pharmaceutical Product Development at TB Alliance, a non-profit organization developing novel TB treatments. His responsibilities include developing drug products, formulating combination products, and designing regulatory and market access strategies... Read More →


Wednesday June 21, 2017 4:00pm - 5:15pm
S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616