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Recent episodes
Preliminary insights from The Regulatory Operational Excellence & World Class RIM Study
Mar 12, 2026
28m 35s
Service Provider Executive Series #18: Rainer Schwarz on Automating Regulatory Review with AI
Feb 9, 2026
28m 04s
Service Provider Executive Series #17: Omar Serang of DNAnexus
Jan 26, 2026
30m 56s
Service Provider Executive Series #16 - Accumulus' Dominique Lagrave on the Future of Global Regulatory Collaboration
Jan 9, 2026
35m 05s
Regulatory Executive Series Special: Remco Munnik (Owner and Founder of Arcana)
Nov 28, 2025
18m 13s
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| Date | Episode | Topics | Guests | Brands | Places | Keywords | Sponsor | Length | |
|---|---|---|---|---|---|---|---|---|---|
| 3/12/26 |  Preliminary insights from The Regulatory Operational Excellence & World Class RIM Study✨ | Regulatory Operational ExcellenceWorld Class RIM Study+4 | Steve GensGreg Brolund | Gens & Associates | — | Regulatory Operational ExcellenceRIM Study+5 | — | 28m 35s | |
| 2/9/26 |  Service Provider Executive Series #18: Rainer Schwarz on Automating Regulatory Review with AI✨ | regulatory softwareAI adoption+3 | Rainer Schwarz | KlearDoc | — | regulatory reviewAI+5 | — | 28m 04s | |
| 1/26/26 | Service Provider Executive Series #17: Omar Serang of DNAnexus✨ | regulatory processesdigitalization+3 | Omar Serang | DNAnexusPrecisionFDA+1 | — | regulatory spacesPrecisionFDA+3 | — | 30m 56s | |
| 1/9/26 | Service Provider Executive Series #16 - Accumulus' Dominique Lagrave on the Future of Global Regulatory Collaboration✨ | regulatory collaborationregulatory operations+3 | Dominique Lagrave | Accumulus Technologies | — | regulatory collaborationAccumulus Technologies+3 | — | 35m 05s | |
| 11/28/25 | Regulatory Executive Series Special: Remco Munnik (Owner and Founder of Arcana)✨ | business creationentrepreneurship+3 | Remco Munnik | Arcana | — | ArcanaRemco Munnik+4 | — | 18m 13s | |
| 11/7/25 | Service Provider Executive Series Episode #15 - Weaving the Future of Regulatory Innovation with Ari Caroline✨ | regulatory innovationgenerative AI+3 | Ari Caroline | Weave | — | regulatory landscapeAI+3 | — | 25m 00s | |
| 10/16/25 | Service Provider Executive Series #14: Building the Operational Fabric of Modern R&D - Toban Zolman, Founder & CEO of Kivo.✨ | R&DAI adoption+3 | Toban Zolman | KivoCROs+1 | — | KivoR&D+5 | — | 27m 12s | |
| 10/2/25 | Service Provider Executive Series #13: Renato Rjavec (ArisGlobal)✨ | advanced technologiesproduct management+3 | Renato Rjavec | NavaXArisGlobal | — | ArisGlobalNavaX+3 | — | 24m 08s | |
| 9/19/25 | Service Provider Executive Series #12 - Anita Modi (Peer AI)✨ | AI authoringAgentic AI+3 | Anita Modi | Peer AI | — | AIauthoring+4 | — | 36m 07s | |
| 9/4/25 | Service Provider Executive Series #11: Kevin Morgan - Glemser✨ | clinical spaceRegulatory Life Science+3 | Kevin Morgan | GlemserRegulatory Operational Excellence & World Class RIM(SM) Study+1 | — | GlemserKevin Morgan+3 | — | 19m 36s | |
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| 8/22/25 | Service Provider Executive Series Episode #10: A discussion with Docuvera's Steve Owens and Murali Menon | In today's episode, host Steve Gens is joined by Docuvera's Steve Owens (Chief Executive Officer) and Murali Menon (Chief Revenue Office). Together, they discuss how Docuvera is meeting the content generation transformation needs in the Regulatory/Clinical space, Structured Content Authoring vs. GenAI, and what to expect from Docuvera in the near future. For inquires into the Gens & Associates Podcast, reach out to our producer at jgens@gens-associates.com Time is running out to enroll in the "Industry Standard" Regulatory Life Science benchmark with Gens & Associates' Regulatory Operation Excellence and World Class RIMSM Study. Visit https://gens-associates.com/world-class-rim-research/ and enroll to make your mark on industry and find how you rank amongst your peers. | 30m 37s | ||||||
| 7/24/25 |  Service Provider Executive Series Episode #9 - Gabor Fari (InteliNotion) | In today's episode, host Steve Gens is joined by Gabor Fari, Co-founder and Principal of InteliNotion, to discuss how structured content authoring has evolved, the value of combining it with GenAI, and what to expect from InteliNotion in the short/long term. | 33m 11s | ||||||
| 7/20/25 | AI / Automation Series Episode #3 | The EU AI Act: What It Means for Regulatory in Life Sciences | Welcome back to the Gens & Associates Podcast AI Series. In todays episode, Host Katherine Yang-Iott and Preeya Beczek discuss the implications of the EU AI Act on Regulatory Organizations - what does the policy want to achieve, what challenges might it create and how regulatory should be preparing. Preeya is a Regulatory process expert and can be reached at preeya@beczek.com or on her LinkedIn: https://www.linkedin.com/in/preeyabeczek/ If you are interested in connecting with G&A team or have inquiries for our podcast, please reach out to our Digital Marketing Lead John Gens at jgens@gens-associates.com Until next time, cheers! | 24m 46s | ||||||
| 5/19/25 | AI / Automation Series #2 - AI and the amplification of Regulatory Work with François Guely | Katherine Yang-Iott sits down with François Guely, VP of Strategic Marketing at Ennov, to explore how AI solutions are transforming regulatory processes—making them faster, smarter, and more efficient. As the landscape evolves over the next few years, what should organizations anticipate? Join us as we dive into the advancements shaping the future. François Guely is an engineer and VP of Strategic Marketing at Ennov and can be reached at fguely@ennov.com. | 20m 29s | ||||||
| 3/26/25 |  AI/Automation Series #1 - Research highlights of our 2025 Regulatory Advanced Technology Survey (41 Companies, 17 Service Providers) | Kicking off this new series on AI/Automation, host Katherine Yang-Iott is joined by study leads Steve Gens and Greg Brolund. Together, they discuss industry / provider readiness for advanced technologies with a focus on AI. Hear about key study takeaways, changing sentiments in the AI era, and other considerations for your Regulatory organization. | 26m 50s | ||||||
| 2/6/25 |  Service Provider Executive Series Episode #8 - Sonia Veluchamy and Punya Abbhi (Celegence) | In today's episode, host Steve Gens is joined by Celegence's Sonia Veluchamy (CEO & Co-Founder) and Punya Abbhi (COO & Co-Founder). Together, they discuss their regulatory services and unique tech enabled toolkits, how Regulatory will evolve with AI / Automation, and Celegence's exciting future! | 34m 26s | ||||||
| 1/30/25 | Service Provider Executive Series Episode #7 Brian Williams (KPMG) | In today's episode, host Steve Gens is joined by Brian Williams (Managing Director at KPMG LLP). Together, they discuss improving operational efficiency and time to market, Innovation in Regulatory and Regulatory R&D function with A.I., and what to expect from the Regulatory practice at KPMG! If you enjoyed this episode, be sure to follow and subscribe to hear more from industry experts and leadership in the Regulatory space! | 28m 26s | ||||||
| 1/28/25 |  Service Provider Executive Series Episode #6 - Frank D'Entrone (FME Life Sciences) | In Today's episode, host Steve Gens is joined by Frank D'Entrone (Head of Global Sales at FME Life Sciences). Together, they discuss Regulatory Modernization and Transformation best practices, AI enabled services, and what to expect from FME in the coming years! | 24m 36s | ||||||
| 1/21/25 |  Service Provider Executive Series Episode #5 - Rachel Belani-Barker (Syneos Health) | In today's episode, host Steve Gens is joined by Rachel Belani-Barker (Managing Partner, R&D Advisory at Syneos Health). Together they discuss supporting client's transition through data strategy cross functionality, AI service tools, and whats up next for Syneos Health's regulatory/R&D practices. | 26m 34s | ||||||
| 1/14/25 |  Service Provider Executive Series Episode #4 - Rowan Nidd (NNIT) | In today's episode, host Steve Gens is joined by NNIT"s Rowan Nidd (Head of RA Advisory and MedTech for Europe). Together, they discuss how NNIT has helped its clients with their digital optimization journey, AI/Automation benefits for Regulatory, and what to expect from NNIT in the coming years! | 30m 36s | ||||||
| 1/6/25 |  Service Provider Executive Series Episode #3 - Toban Zolman (Kivo) | Welcome to the Executive Series of the Gens & Associates Podcast. In today's episode, host Steve Gens is joined by Toban Zolman (CEO of Kivo). Together, they discuss Kivo's success with smaller stage companies, their process for quickly getting clients live on their platform, and Kivo's exciting plans for the future! | 31m 53s | ||||||
| 12/17/24 | Service Provider Series Episode #2 - Marty Boom and Tris Nockles (Navitas) | In today's episode, Steve Gens is joined by Navitas' Marty Boom (Global Head of Regulatory & Safety) and Tris Nockles (Regulatory Nets Lead) to discuss Navitas' "nets" and leading consulting services, opportunities and innovation with AI/Automation in Regulatory, and a look into the future at Navitas! | 32m 04s | ||||||
| 11/8/24 |  Service Provider Series Episode #1: Padmanabham Navuluri (Genpact) | In the premiere episode of our Regulatory Executive Service Provider, host Steve Gens is joined by Padmanabham Navuluri or "Paddy" (Vice President and Head of Pharma Quality and Regulatory Affairs at Genpact) to discuss how Genpact has supported many regulatory organization transformations, the new era of innovation with A.I. and automation, and what to expect from Genpact regulatory services in the future. | 23m 01s | ||||||
| 10/25/24 | Executive Series Episode #9 - Max Kelleher (Generis) | Welcome to The Gens & Associates Podcast: Regulatory Executive Series. This exciting series features Steve Gens, G&A Managing Partner, conversing with key regulatory senior executives that represent the software and services sectors. These informative one on one conversations will explore how they are guiding their organizations to effectively support key industry initiatives and technology advances. In today's episode, host Steve Gens is joined by Max Kelleher (CEO of Generis) to discuss innovations in the CARA Platform, how internal company culture reflects customer satisfaction, and Generis' exciting future. | 29m 57s | ||||||
| 9/18/24 |  Executive Series Episode #8 - Marc Gabriel (Veeva) | In today's episode, Host Steve Gens is joined by Marc Gabriel (VP, Vault Regulatory at Veeva) to discuss Veeva's growth in the regulatory space, customer benefit realization, AI and advanced technology, and what's next for their regulatory practice. | 24m 33s | ||||||
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