RegRapPod TOPRA
-
- Science
-
Welcome to the RegRapPod - the podcast series of the TOPRA member's journal Regulatory Rapporteur. The podcast is published 11 issues time a year, to accompany each issue. Hosted by Managing Editor Alan Booth, the pod welcomes each month the editors for that month's issue. If you'd like to appear as a guest on the podcast, or otherwise contribute to the journal, please email Alan on alan@topra.org
-
In Conversation with Helena Corte-Real - Careers
BONUS EPISODE: In Conversation with Helena Corte-Real
In 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 regulatory via a PhD in marine biology and medical writing.
SHOW NOTES:
Alan Booth presented this podcast and the Producer was Daisy Edwards both at TOPRA in London. If you would like to advertise on the RegRapPod, please contact Erik Smit at erik@topra.org
For any other queries, please write to Alan Booth, Managing Editor, at alan@topra.org -
April 2024 - Data
In this episode of RegRapPod, host Alan Booth hears from Issue Editor, and Regulatory Rapporter Editorial Board member, James McCormick, to discuss the focus topic of this issue which is all things data.
James McCormick is Senior Director, Regulatory Affairs, PPD Global Ltd, UK
----------------------------------------------------------------
SHOW NOTES:
Managing Editor of Regulatory Rapporteur Alan Booth presented this podcast and the producer was Daisy Edwards; both at TOPRA in London.
If you would like to advertise on the RegRapPod, please contact Erik Smit at Erik@topra.org
For any other queries, please contact Daisy at daisy@topra.org, or you can write to Alan Booth, managing editor, at alan@topra.org
S1 Ep 11 -
March 2024 - Asia-Pacific
In this episode of RegRapPod, host Alan Booth hears from Issue Editors, and Regulatory Rapporter Editorial Board members, Vickie Goff and Harriet Edwards, to discuss the focus topic of this issue, the Asia-Pacific region.
Vickie Goff is Head of Marketed Products and Regulatory, CMC, Mundipharma, UKHarriet Edwards is Associate Director, Regulatory Affairs, Boyd Consultants Ltd., UK
----------------------------------------------------------------
SHOW NOTES:
Managing Editor of Regulatory Rapporteur Alan Booth presented this podcast and the producer was Daisy Edwards; both at TOPRA in London.
If you would like to advertise on the RegRapPod, please contact Erik Smit at Erik@topra.org
For any other queries, please contact Daisy at daisy@topra.org, or you can write to Alan Booth, managing editor, at alan@topra.org
S1 Ep 10 -
February 2024 - Medtech
In this episode of RegRapPod, host Alan Booth hears from Issue Editors, and Regulatory Rapporter Editorial Board members, Dejan Brkic and Esteban Herrero-Martinez to discuss the medical technologies focus topic of this issue.
Dejan Brkic is Senior Director Regulatory Affairs, Head of Regulatory Development Solutions at PPD, part of Thermo Fisher Scientific, in Cambridge.Esteban Herrero-Martinez is Director of Regulatory Policy and Intelligence at AbbVie, in Slough.----------------------------------------------------------------
SHOW NOTES:
Managing Editor of Regulatory Rapporteur Alan Booth presented this podcast and the producer was Daisy Edwards; both at TOPRA in London.
If you would like to advertise on the RegRapPod, please contact Erik Smit at Erik@topra.org
For any other queries, please contact Daisy at daisy@topra.org, or you can write to Alan Booth, managing editor, at alan@topra.org
S1 Ep 9 -
In Conversation with TOPRA’s RegOps SPIN
BONUS EPISODE: In Conversation with TOPRA's RegOps SPIN
In 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 Consultant, R&D Business Consulting at BASE life scienceVigneshram Rengarajan, Manager, R&D Business Consulting at BASE life scienceElisabetta Rossi, Regulatory Affairs Senior Director - Primary & Specialty Care and Global Operations, Dompé farmaceutici S.p.A.Daniele Severa, Digital Regulatory Affairs Senior Specialist, Dompé farmaceutici S.p.A.SHOW NOTES:
Managing Editor of Regulatory Rapporteur Alan Booth presented this podcast and the producer was Daisy Edwards; both at TOPRA in London.
If you would like to advertise on the RegRapPod, please contact Erik Smit at Erik@topra.org
For any other queries, please contact Daisy at daisy@topra.org, or you can write to Alan Booth, managing editor, at alan@topra.org -
January 2024 - Biologics
JANUARY 2024
In this episode of RegRapPod, host Alan Booth hears from Issue Editors, and Regulatory Rapporter Editorial Board members, Ash Ramzan and Julie Warner to discuss their Biologics issue of the journal.
Ash Ramzan is Principal Consultant at Woodley BioReg, in Huddersfield, West Yorkshire.Julie Warner is Vice President, Regulatory Affairs at Boyds Consultants in the UK
SHOW NOTES:
Managing Editor of Regulatory Rapporteur Alan Booth presented this podcast and the producer was Daisy Edwards; both at TOPRA in London.
If you would like to advertise on the RegRapPod, please contact Erik Smit at Erik@topra.org
For any other queries, please contact Daisy at daisy@topra.org, or you can write to Alan Booth, managing editor, at alan@topra.org
Customer Reviews
CMC classic question on Small Molecules Drug Product Submission
It will be useful to hear CMC related classical questions and responses expected from MAH.
Please do a few podcast for listeners with some case studies to give a perspective.
Best podcast ever!!
RegRapPod is the best and arguably most informative podcast in the whole regulatory affairs space.