Join us for an exciting day filled with engaging and relevant PV-related topics designed to inspire and inform in this FREE one-day convention in Basel.
Our agenda will feature insightful sessions from distinguished speakers in the field. Thomas McConnon, Global Head PS&PV External Engagements, Novartis will present on "ReVA – Supporting Portfolio Transformation via Digitalisation of End-to-End PV Agreements Management", Thomas Hornbæk Svendsen, Consulting Director, R&D Solutions, NNIT and Helle von der Recke-Heisel Vice President of Global Drug Safety and QPPV at Pharmacosmos will cover the comprehensive journey from preparation to hypercare, using a real example of a project lifecycle.
We are thrilled to invite you to Insife Annual Convention!
Connect. Collaborate. Community.
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Don't miss this rare opportunity to network and connect with fellow pharmacovigilance professionals who share your passion for advancing the field.
We look forward to seeing you at our annual convention. If you have any questions, please don't hesitate to contact us at hello@insife.com.
To see how it was at last year's convention, please click here.
Event details
Date: 26th September 2024
Time: 09:00*-17:00 CET
Location: Novartis Campus, Basel, Switzerland
*Registration & breakfast start at 08:00 CET
Registration closed!
Agenda
08:00 - 09:00
Registration & breakfast
09:00 - 09:15
Jen Markey
CSMO, Insife
Welcome & Review of the Day
09:15 - 09:45
ReVA – Supporting Portfolio Transformation via Digitalisation of End-to-End PV Agreements Management
09:45 - 10:15
Martin Holm-Petersen
CEO, Insife
The Roadmap for PV innovation. HALOPV 6.0 revealed and beyond – The future of technology-led PV innovation from now towards 2030
10:15 - 10:45
Coffee break
11:15 - 11:45
Innovation - it’s a team sport, it’s a community initiative
11:45 - 12:15
Michael von Forstner
Head of Global Safety Science, SOBI
Machine learning in signal management
12:15 - 13:15
Lunch
13:15 - 13:45
Innovating Patient Safety, a regulators perspective
13:45 - 14:15
Helle von der Recke-Heisel
Vice President of Global Drug Safety
and QPPV, Pharmacosmos
The journey from preparation to hypercare when moving to a new PV system
14:15 - 14:45
Challenges in the automation of aggregate reporting
14:45 - 15:15
Coffee break
15:15 - 15:45
Louise Tan
Head of GRIP Services, Insife
Getting a GRIP on Regulatory Intelligence
15:45 - 16:15
Latika Sharma
Strategic PV Thoughtlead, Navitas Life Sciences
Highlights from this years pvnet benchmark
16:15 - 16:45
Risk Management in Pharmacovigilance: Global Strategy, Local Solutions
16:45 - 17:00
Closing ceremony
Phil Tregunno
Deputy Director, Patient Safety Monitoring, Safety and Surveillance, MHRA
Sarah Vaughan
Head of Vigilance Operations at MHRA
Thomas Hornbæk Svendsen
Consulting Director, R&D Solutions, NNIT
James Whitehead
Senior Director, AstraZeneca
Henry Barton
Global Safety Lead, Grünenthal
Thomas McConnon
Global Head PS&PV External Engagements, Novartis
Florian Goergens
Project Lead, Bayer
10:45 - 11:15
Improving patient outcomes and accelerating science with Generative AI and Data
Chris McCurdy
Chief Architect, Healthcare and Life Sciences AWS
Speakers
Martin Holm-Petersen, CEO Insife
Executive leader with 10 years of experience within the pharma industry and another 10+ years in consulting. Martin is an experienced manager and strategist, with understanding across the pharma business value chain, and an expert on Pharmacovigilance. His current role is CEO of Insife, a global technology and consulting company. In this capacity, digital transformation is central to Martin’s engagements with Industry and Regulatory Agencies.
The upcoming online event will delve into topics of innovation in case intake, exploring the different approaches to technology, featuring insights from industry experts, and examining the integration of AI within intake processes and the diverse approaches to tackling this challenge.
Presentation name: The Roadmap for PV innovation. HALOPV 6.0 revealed and beyond – The future of technology-led PV innovation from now towards 2030
Louise Tan, Principal PV Consultant and Head of GRIP Services, Insife
Louise is a PV subject matter expert with 15+ years of experience within Industry, consulting, PV network leadership and project management, combining deep domain knowledge with strong presentation, facilitation and problem-solving skills. She joined Insife in December 2022 with an aim to expand her horizons in the PV tech ecosystem and works with both Industry and Regulators to implement game changing technologies. Louise currently leads our Global Regulatory Intelligence Club for Pharmacovigilance (GRIP).
Presentation name: Getting a GRIP on Regulatory Intelligence
James Whitehead, Senior Director at AstraZeneca
James is a Patient Safety professional with over 10 years of experience in life sciences, holding a BSc in Psychology, an MSc in Pharmacovigilance and currently studying for an MBA where his focus is innovation within pharmacovigilance, what are the components of a successful innovation ecosystem?
The majority of James’ career has been spent in core Pharmacovigilance activities, from literature monitoring and case processing through to authoring risk management plans. In the last few years, James has been supporting the inclusion of medical devices and digital health requirements/demands into AstraZeneca Global Patient Safety organization.
Presentation name: Innovation - it’s a team sport, it’s a community initiative
Henry Barton, Global Safety Lead at Grünenthal
Henry Barton is a physician and pharmacovigilance expert with a expertise in surgery, anesthesiology and drug safety. He has over a decade of hands-on experience in various clinical settings, including intensive care and emergency medicine.
As a Global Safety Lead at Grünenthal, Henry oversees the pharmacovigilance activities around several post-marketing products, such as esomeprazole and zolmitriptan. He is also responsible for designing and implementing risk management strategies, including innovative software solutions, which simplify workflows and enhances the efficiency of drug safety monitoring and risk mitigation. He is also involved in the creation and submission of risk management plans, with a special focus on the anonymization of privacy-sensitive data and the protection of confidential corporate information. Furthermore, Henry has an interest in benefit-risk methodology and its use to navigate complex assessments that confirm the positive benefit-risk balance of medicinal products.
Presentation name: Risk Management in Pharmacovigilance: Global Strategy, Local Solutions
Thomas Hornbæk Svendsen, Consulting Director, R&D Solutions, NNIT
Thomas has worked for more than 20 years as a consultant and project manager within life sciences in projects covering a comprehensive range of business processes areas, including primarily Regulatory Affairs but also Drug Development and Drug Safety. Thomas has built his expertise from working in the cross-field between Line of Business and IT, managing and assisting projects with focus on operational excellence while maintaining the adequate level of compliance.
Presentation name: The journey from preparation to hypercare when moving to a new PV system
Thomas McConnon, Global Head PS&PV External Engagements, Novartis
Thomas is a Patient Safety professional with over 18 years of broad experience in Pharmacovigilance, holding a BSc in Pharmacology and n MSc in Pharmaceutical Analysis. His current focus is on driving transformation and innovation in Pharmacovigilance Operations, with a significant emphasis on external partnership management.
Thomas career has been spent in small, medium and large sized Pharma companies, as well as the CRO industry. During his time he has had direct involvement in all aspects of the global PV system, both in SME roles and leadership roles, including the role as EU QPPV.
Presentation name: ReVA – Supporting Portfolio Transformation via Digitalisation of End-to-End PV Agreements Management
Helle von der Recke-Heisel, Vice President of Global Drug Safety and QPPV, Pharmacosmos
Helle von der Recke-Heisel is the Vice President of Global Drug Safety and QPPV at Pharmacosmos, where she has spent the last 10 years of her career. With over 18 years of experience in pharmacovigilance across various global pharmaceutical companies, she brings deep expertise to her role. Helle holds a Doctor of Veterinary Medicine degree and initially joined Pharmacosmos as Medical Safety Director. For the past 1½ years, she has been heading the Global Drug Safety department as Vice President, focusing on ensuring drug safety and compliance worldwide.
Presentation name: The journey from preparation to hypercare when moving to a new PV system
Latika Sharma, Strategic PV Thoughtlead, Navitas Life Sciences
Dr Latika Sharma, MBBS., MD is a post graduate physician, passionate about Patient safety in a digital world. With over two decades of clinical, academic & industry experience, Latika brings a broad perspective of international Life Sciences experience across multiple product categories to her work.
She is currently a Strategic Thoughtlead for PV & MedTech at Navitas Life Sciences. She leads several of the Navitas portfolio of industry networks pvnet/pvtech/ medtechnet & supports CMOnet, engaging with business leaders & CMOs to shape the future of PV & R&D. A key aspect of her role is leading the flagship annual pvnet benchmark, which for over 20 years has been a ‘go to standard’ for PV leadership seeking industry trends, peer to peer PV performance comparison & insights into future trajectories. As a senior management consultant, she helps PV business leaders explore possibilities & generate fresh ideas for success across Strategy, process, technology & operating models.
Presentation name: Highlights from this years pvnet benchmark
Florian Goergens, Project Lead, Bayer
Florian Goergens began his journey at Bayer in 2014 as part of the dual study program, where he pursued a degree in business informatics. By 2017, he had transitioned into the field of pharmacovigilance (PV), contributing to various IT projects. Today, Florian serves as a project lead, continuing to drive innovation and excellence at Bayer.
Presentation name: Challenges in the automation of aggregate reporting
Chris McCurdy, Chief Architect of Healthcare and Life Sciences (HCLS) for Amazon Web Services (AWS)
Chris McCurdy serves as Chief Architect of Healthcare and Life Sciences (HCLS) for Amazon Web Services (AWS), where he leads teams responsible for architecting cutting-edge services, unlocking data assets and opening novel analytics capabilities. With over 20 years of industry experience, Chris plays a key role in envisioning and developing innovative solutions and services that accelerate customers value while improving patient outcomes. Chris has a B.S. in Mathematical Sciences from Oregon State University, with graduate work focused on statistics and set theory.
Presentation name: Improving patient outcomes and accelerating science with Generative AI and Data
Michael von Forstner, Head of Global Safety Science, SOBI
Dr. Michael Forstner is Head of Global Safety Science at SOBI, focussing on ensuring the establishment and maintenance of favourable benefit-risk profiles of medicinal products in the rare disease space in clinical development and in real-world use. Michael has over 20 years industry experience in various roles in R&D and drug safety in different pharmaceutical companies and as a consultant and has contributed to several successful marketing authorizations of innovative medicines by developing workable, efficient benefit-risk management measures, mostly in the oncology and CNS therapeutic areas. He is currently driving the utilization of RWE in pharmacovigilance processes, as well as applications of artificial intelligence in the understanding of clinical outcomes.
As a past chair of the PV Working Group of Medicines for Europe, he has been representing the organization at EMA working group and stakeholder meetings, driving an industry position that shows the industry as pro-active partners of regulators, HCPs and patients in ensuring the safety and effectiveness of medicines. Michael also represented the International Generics and Biosimilars Association at the ICH and was topic leader in the ICH M14 WG on Real-World Data for the Safety Assessment of Medicines. In addition, he acts as instructor for DIA courses on benefit-risk and signal management, as well as at the European Centre for Pharmaceutical Medicine and is a frequent speaker at international scientific and industry conferences.
Presentation name: Machine learning in signal management