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RegRapPod: InConversation

RegRapPod
Regulatory Affairs
Joint Clinical Assessment (JCA)
European HTA Regulation
Topra
Clinical Trials
Artificial Intelligence
Patient Voice
Parexel
Oncology
Globalization

RegRapPod: InConversation is the podcast series of the TOPRA member's journal Regulatory Rapporteur. If you'd like to appear as a guest on the podcast, or otherwise contribute to the journal, please email claire.mcdermott@topra.org.

PublishesInfrequentlyEpisodes10Foundeda year ago
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Health & FitnessMedicine

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Artwork for RegRapPod: InConversation

Latest Episodes

In this episode of RegRapPod – InConversation, host Claire McDermott talks with TOPRA President Aman Khera about the ever-changing world of regulatory affairs and how TOPRA can support professionals navigate this complex landscape.

In this episode of RegRapPod – InConversation, co-hosts Claire McDermott and Ming Ewe sit down with Magda Papadaki, CEO of CoreTech Sciences and Venture Adviser, to explore how regulatory professionals can unlock new, entrepreneurial career opportuni... more

In this episode of RegRapPod – InConversation, host Claire McDermott talks with Sangeeta Budhia, Senior Vice President and Global Head of Pricing, Market Access and Evidence Evaluation, and Sinan Sarac, Senior Vice President and Head of Oncology Euro... more

In this episode of RegRapPod – InConversation, host Claire McDermott talks with Zohra Nasir, Senior Manager Regulatory Affairs at Teva Pharmaceutials, and Aksa Rahman, Regulatory Affairs Project Manager at Grunenthal Ltd, about careers in regulatory ... more

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Recent Guests

Aman Khera
Regulatory leader and president of Topra
Topra (The Regulatory Affairs Professional Society)
Episode: Opportunities, challenges and how to future-proof regulatory affairs
Magda Papadaki
Regulatory entrepreneur and venture builder
CoreTech Sciences
Episode: How to build a portfolio career using your regulatory expertise
Sangeeta Budhia
Senior Vice President, Parexel; Global Head of Pricing, Market Access and Evidence Evaluation
Parexel
Episode: Joint Clinical Assessment: How to align your regulatory and access strategies
Sinan Sarac
Senior Vice President and Head of Oncology Europe Regulatory Consulting; former EMA CHMP member
Parexel
Episode: Joint Clinical Assessment: How to align your regulatory and access strategies
Aksa Rahman
Regulatory Affairs Manager at Grunenthal Ltd
Grunenthal Ltd
Episode: Careers: Landing your first role in regulatory affairs
Zohra Nasir
Senior Manager Regulatory Affairs at Teva Pharmaceuticals
Teva Pharmaceuticals
Episode: Careers: Landing your first role in regulatory affairs

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Talking Points

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Joint Clinical Assessment: How to align your regulatory and access strategies
Q: Sinan, can you talk to us a bit about how the joint clinical assessment changes the European market access landscape and why it matters for regulatory professionals?
JCA shifts thinking earlier in development, emphasizing integrated evidence generation to support reimbursement alongside regulatory submissions, and aims to shorten time to market by aligning evidence needs across regulators and payers from the outset.
Opportunities, challenges and how to future-proof regulatory affairs
Q: What are the biggest challenges and opportunities facing the industry today, and how can Topra help?
He highlights disruption from funding, regulatory changes, and AI, balanced by opportunities from technology to speed and improve regulatory work. He stresses patient-centric considerations, global collaboration, and Topra's role in providing education, webinars, and a supportive community to help members future-proof their careers.
Opportunities, challenges and how to future-proof regulatory affairs
Q: Tell us about your background and what led you to Topra and your presidency.
Aman shares a long, intertwined journey from his early interest in combining science with business to discovering regulatory affairs through a pamphlet, then joining a CRO as a new graduate. He underscores volunteering with Topra as a pivotal driver of his leadership path and notes that his presidency reflects a commitment to upskilling and evolving with industry changes.
How to build a portfolio career using your regulatory expertise
Q: Magda, what does the regulatory professional of the future look like in a data-driven, AI-enabled healthcare landscape?
They must become scientists again in spirit, embracing uncertainty, integrating patient input, and balancing explainability, transparency, and continuous learning with regulatory needs.

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What guests have appeared on RegRapPod: InConversation?

Recent guests on RegRapPod: InConversation include:

1. Aman Khera
2. Magda Papadaki
3. Sangeeta Budhia
4. Sinan Sarac
5. Aksa Rahman
6. Zohra Nasir

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