Rare Disease/Gene Therapy

Focus Area Working Group

Members

Ashish Dugar

Ashish Dugar

Lead

FAWG Overview

Compliance Updates

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Make Communications, Not War: Best Practices for Medical, Legal and Regulatory Review

This MAPS webinar details potential hurdles of the MLR review process​, function alignment, and our changing MLR environment and possible solutions.
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Enforcement and Compliance ​ in Current Times

This MAPS webinar details enforcement trends, key risks associated with the shift from in-person to virtual activities due to the pandemic and compliance considerations for conducting promotional and educational activities virtually.
Pandemic Silver Lining Featured
EU.MedTech.ELEVATE.Featured
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A Compelling Strategic Role for Medical Affairs in the Context of the new EU MedTech Regulations

This article provides an overview of the new MedTech European regulatory environment and opportunities for the Medical Affairs function to evolve and bring value to the respective organizations.
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Impact of COVID-19 on Global MA Compliance Panel

Join expert panelists on this Webinar to better understand compliance implications of the changing business models during and post-COVID, and identify Medical Affairs compliance risks and mitigation strategies.
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Medical Affairs Excellence and Ethics & Compliance in the Evolving Healthcare Landscape – Collaborating and Leading by Example

This Webinar explores: the role of Medical Affairs in guiding ethical decisions internally and externally; the impact of Medical Affairs beyond its remit; the importance of sharing best practices for the role of Medical Affairs in strategic brand planning, and the ethics and compliance considerations for Medical Affairs plans.
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Compliance Considerations in Medical/Commercial Collaborations

In this webinar, we explore two scenarios that can open Medical Affairs up to censure. Scenario one explores participation of commercial team members in Medical Advisory Boards and scenario two looks at the implications of a commercial team member requesting a medical team member to participate in a thought leader meeting.