RegRapPod: InConversation
RegRapPod: InConversation is the podcast series of TOPRA's members' journal, Regulatory Rapporteur. It features conversations connected to the journal and the regulatory affairs profession. The show offers discussion and insight from people involved in regulatory work. It also invites listeners to contribute to the journal or appear as guests.
Episodes
Conditional marketing authorisation in the EU: Manging the path from approval to full licence
InConversation talks about conditional marketing authorisation − and how the work starts after approval – with Catherine MoncadConditional marketing authorisation (CMA) can help bring innovative medicines to patients with high unmet medical need sooner. But for sponsors, particularly emerging biotechs and first-time marketing authorisation holders, approval is only the beginning.In this latest epi
Opportunities, challenges and how to future-proof regulatory affairs
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.
How to build a portfolio career using your regulatory expertise
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 opportunities.
Joint Clinical Assessment: How to align your regulatory and access strategies
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 Europe, Regulatory Consulting, both at Parexel, about Joint Clinical Assessment (JCA) implementation in Europe.Established under Regulation EU 2021/2282,
Careers: Landing your first role in regulatory affairs
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 affairs and, in particular, how you find your first role.Aimed primarily at students, graduates and those who are considering a career in regulatory a
FAMHP: The role of the Belgian Agency in advancing public health
In this episode of RegRapPod – InConversation, host Claire McDermott and members of TOPRA’s Benelux Steering Group talk with Hugues Malonne, Chief Executive Officer of Belgium’s Federal Agency for Medicines and Health Products (FAMHP) about the Agency’s strategic priorities, its role in shaping and facilitating European legislation and how it collaborates with other regulators, both within and out
InConversation with Ivo Claassen - Veterinary Regulation 2019/6: Impact, challenges and the future
InConversation talks veterinary regulation with Ivo ClaassenIn this episode of RegRapPod - InConversation, host Claire McDermott talks with Ivo Claassen, Head of the Veterinary Medicines Division and Deputy Executive Director of the European Medicines Agency (EMA) about Veterinary Regulation 2019/6. This legislation represents a fundamental overhaul of the regulatory system for veterinary medicine
InConversation with the UK ePI Task Force - The path to a digital future
In this episode of RegRapPod - InConversation, host Claire McDermott hears from Andrew Burgess of Sanofi and Michael Clarke of the British Generic Manufacturers Association who are both members of the UK ePI Task Force. This Pod explores electronic product information (ePI) for medicinal products and asks why it's important, what the implementation challenges are for industry and how the Task Forc
InConversation with Bengt Mattson - Sustainability
BONUS EPISODE: In Conversation talking careers with Bengt Mattson In this episode of RegRapPod - In Conversation, host Alan Booth hears from Bengt Mattson who is Policy Manager at LIF, which is the trade association for the research-based pharmaceutical industry in Sweden. Bengt previously gave the Welcome Lecture to launch the TOPRA Symposium 2023. Here the pod caught up with Bengt for a wide-r
InConversation with Helena Corte-Real - Careers
BONUS EPISODE: In Conversation with Helena Corte-RealIn this episode of RegRapPod - In Conversation, host Alan Booth hears from Helena Corte-Real who is Vice President, Regulatory Portfolio Data and Content Lead with Roche in Basel, Switzerland. Helena has previously been a speaker at TOPRA’s Regulatory Careers Live events and the pod caught up with her to hear about her career path into regulator
InConversation with TOPRA’s RegOps SPIN
BONUS EPISODE: In Conversation with TOPRA's RegOps SPINIn this episode of RegRapPod - In Conversation, host Alan Booth hears from industry experts about the Identification of Medicinal Products (IDMP) requirements and how organisations are navigating the challenges it is posing for industry and the opportunities they also bring. Joining Alan on the podcast are:Ramón Hernández Moratinos, Senior Con
