We are thrilled to invite you to the Insife Annual Convention
Innovation. Integrity. Imagination.
This event is a fantastic opportunity to engage with the pharmacovigilance community and also with Insife, in this free one-day event in Copenhagen. The event will feature presentations by industry leaders in drug safety technology, including Mick Foy from the MHRA and Anne Kraemmer from LINK Medical. There will also be other keynote speakers, including Insife’s CEO Martin Holm-Petersen and a panel discussion where you can join in and have your say.
Topics will include the emerging trends across regulatory agencies, big pharma, SMB pharma/biotech companies, CROs and service providers; an update on the MHRA's SafetyConnect program; the impact of the ever-changing global regulatory requirements, and fascinating insights and perspectives on industry trends and how the Insife experts and our speakers see technology driving innovation and improving patient outcomes.
This is a rare opportunity to network and connect with fellow pharmacovigilance professionals who share your passion for improving patient safety. We look forward to seeing you at the event.
Date: 7th September 2023
Location: København, Oslo Pl. 2, 2100 København Ø, Denmark
Key Note Speakers & Presenters
Director of Delivery, MHRA
Mick Foy is a highly experienced professional who has served the Medicines and Healthcare products Regulatory Agency (MHRA) for over 38 years. He is currently the Director of Delivery, responsible for overseeing a wide range of cross-agency programs and international projects aimed at transforming service MHRA provide. Mick is a recognized expert in pharmacovigilance and serves as the Chair of the MedDRA Management Committee. He is passionate about ensuring that patients worldwide have access to safe and effective medicines and has been recognized with several awards for his contributions to the field.
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. In his previous role, he headed the pvtech global industry pharmacovigilance technology network with more than half of top 100 pharma participating.
Safety Director, LINK Medical
Anne Kræmmer is a highly experienced Safety Director at LINK Medical, a renowned full service clinical research organization. With almost two decades of experience within the pharmaceutical industry, Anne has served in various capacities in global and esteemed organizations. In her current role, she is accountable for ensuring the safety and well-being of clinical trial participants by overseeing adverse event reporting, risk management, and pharmacovigilance activities. Anne brings to the table her regulatory compliance knowledge and drug safety strategies to support the development and approval of new medicinal products.
Interim Head of Pharmacovigilance and Patient Safety, Oncopeptides
Jeff holds a degree in computer science and has been a pharmacovigilance consultant for over 25 years working with Heads of Safety and Chief Medical Officers at companies across the United States, Europe, and Asia. He has extensive experience ranging from multi-functional governance frameworks covering Medical, Benefit-Risk, and Affiliates to technology assessments and implementations. He is currently the Interim Head of Pharmacovigilance and Patient Safety at Oncopeptides, a global biotech company focusing on research, development and commercialization of targeted therapies for difficult-to-treat haematological diseases.
Director, Global Pharmacovigilance Agreements and Alliances in the Global Clinical Safety and Pharmacovigilance group, CSL Behring
With over 25 years in the Pharmaceutical Industry, he has established a proven track record in Pharmacovigilance Systems, Quality Systems and Vendor & Inspection Management. In his current role, Andrew has ownership and responsibility for providing strategic leadership related to pharmacovigilance agreements and compliance with applicable PV regulations and requirements. Andrew is responsible for providing strategic leadership related to pharmacovigilance agreements across the entire product lifecycles and is the key contact person partnering with internal and external stakeholders, setting standards and drive effective and synergistic engagement of all stakeholders as well as continuous improvement initiatives.
Ea Marie Holst
Director, Pharmacovigilance Compliance at Novo Nordisk
She is a highly experienced pharmacovigilance professional with 18 years of experience in the pharmaceutical industry. Currently, Ea is Director of GS Compliance in the QPPV Office of Global Safety at Novo Nordisk, where she provides strategic leadership related to pharmacovigilance agreements and compliance with applicable PV regulations and requirements. Ea is a valued member of the QPPV Office management team and key contact person partnering with internal and external stakeholders to drive effective and synergistic engagement of all stakeholders as well as continuous improvement initiatives.
Global Patient Safety 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. 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.
Chief Sales & Marketing Officer, Insife
Jen has 25+ years of industry, consulting, and software development experience in the Pharmaceutical & Financial Pricing industries. The last 23 years of her career have been focused on Drug Safety & Pharmacovigilance and she has worked with many of the top pharmaceutical and biotechnology companies in the world, including leadership roles at Johnson & Johnson and Pfizer. She also spent many years working as a management consultant where she focused on helping a wide range of clients establish, improve and streamline their safety processes and technology solutions.
Head of Strategic Partnering and US Consulting and Operations, Insife
Wilfred is part of the global leadership team and his main areas of responsibility include the design and oversight of large, global business improvement programs, as well as business development and client relationship management. Over the years Wilfred has been engaged with many of the top 100 Pharma and Biotech companies, to develop and implement their overall Safety and Risk Management strategies across the US and Europe.
Dr. Marc Zittartz
Managing Director, Germany and Head of Customers and Projects Central Europe, Insife
Marc is an experienced leader and consultant in pharmacovigilance technology and processing. He is based out of Cologne, Germany.
Marc has been crossing the frontier between IT and R&D in the pharmaceutical industry in Europe and the USA for more than 15 years. He supports R&D divisions to improve their business processes through the optimized use of information technology.
Regulatory Intelligence Consultant & Product Owner, Insife
Filip is an exceptional Regulatory Intelligence expert in Pharmacovigilance with over 7 years of experience. His meticulous attention to detail and analytical mindset enable him to monitor and analyze evolving regulations effectively. As a highly trusted professional, his expertise in safety reporting processes adds immense value to the industry, navigating complexities with great success. Filip's contribution ensures compliance and promotes patient safety in the pharmaceutical landscape.
Thursday 07th September
08:30 - 09:00
Coffee and croissant
09:00 - 09:15
Welcome / Jen Markey, Chief Sales & Marketing Officer, Insife
09:15 - 09:45
Presentation: How is the PV industry evolving? / Martin Holm-Petersen, CEO, Insife
Martin will take a look at emerging trends across regulatory agencies, big pharma, SMB pharma/biotech companies, CROs, and service providers. He will explore how Insife utilizes and innovates with cutting-edge technologies like AI and ChatGPT for pharmacovigilance (PV), paving the way for new advancements in the field!
09:45 - 10:30
Keynote presentation: SafetyConnect / Mick Foy, Director of Delivery, MHRA
Globally recognized PV expert Mick Foy will provide an update on the MHRA's SafetyConnect program and how it aims to connect all vigilance activities on common technical platforms, greatly improve the user experience and ultimately how it is making patients safer and more knowledgeable.
10:30 - 11:00 Coffee break / Networking
11:00 - 11:30
Presentation: Can we let Pharmacovigilance be disrupted? Looking at Innovations James Whitehead, Global Patient Safety, AstraZeneca
Focusing on the potential of innovation and digital transformation to either incremental or radical disruptive patient safety, James will focus on some of those opportunities and how they could be achieved through an innovation ecosystem.
11:30 - 12:00
Presentation: HALOPV Unleashed: Introducing the Latest Features and Modules / Dr. Marc Zittartz, Managing Director, Germany and Head of Customers and
Projects Central Europe, Insife
Marc has been crossing the frontier between IT and R&D in the pharmaceutical industry in Europe and the USA for more than 15 years. The presentation will showcase the latest features and modules of HALOPV, providing attendees with a comprehensive overview. Additionally, it will delve into the future developments and roadmap of HALOPV, paving the way for exciting advancements in the field of drug safety.
12:00 - 12:15
Presentation: Partnering with Insife / Wilf Gilich, Head of Strategic Partnering and US Consulting and Operations, Insife
An expert in developing and implementing Safety and Risk Management strategies across the US and Europe, Wilf will briefly explain Insife's partnership opportunities and how they can benefit our customers by providing a wide range of services globally.
12:15 - 13:00 Lunch / Networking
13:00 - 13:30
Presentation: Ea Marie Holst, Director, Pharmacovigilance Compliance, Novo Nordisk
To be announced
13:30 - 14:00
Presentation: Innovations and Challenges: A CRO Perspective / Anne Kraemmer, Safety Director, LINK Medical
Safety Director at renowned CRO LINK Medical, Anne will talk about the innovations within her company and how they can positively impact the challenges faced by pharma companies.
14:00 - 15:00
Presentation and Webinar: Introducing Insife's new PV solution which is set to revolutionize the industry / Jen Markey, Chief Sales & Marketing Officer, Insife and Martin Holm-Petersen, CEO, Insife.
Insife will unveil its brand new, ground-breaking solution that is set to become a game changer for pharma companies big and small. Follow us on social media to learn more over the coming months about HALOPV and our developments.
Unable to join us in person? No worries! Sign up for our webinar and discover how PROHALO is set to become a game changer for pharma companies big and small.
15:00 - 15:30 Coffee break / Networking
15:30 - 16:00
Presentation: Development and Implementation of a Pharmacovigilance Vendor Oversight System using HALOPV / Andrew Bond, Director, Global Pharmacovigilance Agreements and Alliances in the Global Clinical Safety and Pharmacovigilance group, CSL Behring
Drawing from his expertise in the field, Andrew will showcase how HALOPV can be leveraged to establish an efficient and robust vendor oversight system for pharmacovigilance.
16:00 - 16:30
Presentation: Signal Management at SMEs / Jeffrey Ho, Interim Head of Pharmacovigilance and Patient Safety, Oncopeptides
Jeff will highlight why Oncopeptides chose HALOPV as its validated signal management solution, how it uses it, and what its plans are for further leveraging the solution in the future.
16:30 - 16:45
Presentation: Navigating Global Regulatory Changes / Filip Beljan Regulatory Intelligence Consultant & Product Owner, Insife
Filip will discuss the global changes in regulatory intelligence over the past year and will explore their implications. He will present the most effective strategies for navigating this complex area and advise on the best methods to ensure that both evolving regulations and established guidelines are tracked, assessed and adhered to.
16:45 - 17:00 Closing Ceremony and drinks