Thank you for your interest. Due to personal circumstances the webcast will be postponed to the beginning of 2023. We will also use this extra time to work on the format and make it an even better experience.

Stay tuned for a new date! You can register for the event when a new date is set.

Looking back and forward in our quest to make an impact

2022 will be marked as a year full of hope, making progress and optimism. But also a year where we are still impacted by the pandemic, a war and environmental challenges. In this live webcast, our experts will look back at 2022 from a regulatory perspective. We will share our lessons learned and will present the challenges and wins, seen in various projects and in the regulatory playing field.

More importantly, we will look forward to 2023; with a critical view on the progress that has to be made and the impact we actually make on the lives of patients, we will discuss the future of regulatory; what we think that future holds and how we can best prepare.

In a special studio, Kalpita Patel will be joined by Frits Stulp, Amy Williams and Paulien Nuyts to discuss questions such as:

• What are the lessons learned in crises and how does this impact patients, access and availability of medicines and human resources?
• How do topics such as data standards and governance relate to patients and the future of Health? And what have we seen in 2022 that convinces us that interoperable regulatory data is coming?
• What is our task to recounter current and future crises and improve general patients’ health? How does this influence the strategic decisions and operational practicalities for the management of data?

These topics will be viewed from 3 perspectives; Regulatory Information Management and IDMP, Clinical and Shortages and Data Management.


Frits Stulp – Managing Director Iperion / Partner Deloitte
Focus on Regulatory Information Management and IDMP
Frits is a valued strategic advisor to the Life Sciences industry, relevant regulators and software providers. With a background as Program Manager and Advisor in Information Management, process design and Regulatory Compliance, specialized in the implementation of both XEVMPD and ISO IDMP requirements, Frits lead numerous projects. He worked at a top20 pharmaceutical for many years and has been co-founder of Iperion Life Sciences Consultancy. Besides his role at Iperion/Deloitte, Frits is Chairman of the Board of CTADHL, the IRISS IDMP topic group and a well-known speaker. His specialties are Regulatory Information Management, Substances, program management, information strategy and process improvements.


Paulien Nuyts – Junior Manager Life Sciences Deloitte
Focus on Clinical and Shortages
Paulien is an experienced Life Sciences professional. She has 4+ years’ experience in public health research and 3+ years’ experience in the Life Sciences industry specifically in the Regulatory field. Paulien is keen on addressing regulatory challenges from all perspectives including those from the European Medicines Agency, National Competent Authorities, Pharmaceutical industry and Patients. She has specific expertise in clinical trials and has led large CTR (Clinical Trial Regulation) implementation programmes at both the industry and the regulator level requiring strong stakeholder and team management. She has also supported companies and regulators in realising their regulatory strategies. Paulien has more recently gained experience in the Regulation for Monitoring of Shortages of Medicinal Products and Devices and what this means for Industry and Member States. She continues to explore the different facets of the Regulatory world.


Amy Williams – Director Iperion – a Deloitte business
Focus on Data Management
Amy is an experienced Life Sciences professional with over 15 years working within Regulatory Affairs across various roles. With experience in Regulatory Affairs, Regulation Information Management, the EMA IDMP Task Force, software vendors and consulting, Amy’s passion is understanding the current challenges and needs of the regulatory industry and how we can work together with industry, regulatory health authorities and vendors to alleviate these. In her role at Deloitte, Amy works closely with clients on strategic IDMP projects as well as leading the LSHC Operate team within the Netherlands. Outside of her role at Deloitte Amy puts her hard won skills to work dedicating much of her free time to Chairing the local school PTA to raise much needed funds and community spirit (!).


Kalpita Patel – Junior Manager Life Sciences Deloitte
Moderator
Kalpita is a Life Sciences professional with experience in both Deloitte’s U.S. and Netherlands Risk Advisory practice, focusing on Regulatory Compliance and Operational Risk. With a background in Public Health, Improv Comedy, and Health Communication & Promotion, she brings strong interpersonal and program management skills to developing trans-Atlantic Regulatory Transformation and Compliance strategies surrounding EU CTR, IDMP, and the Monitoring of Shortages of Medicinal Products and Devices. Outside of her role at Deloitte, Kalpita has 10+ years in improv comedy and public speaking experience, and hopes to continue using impactful story-telling to improve individual and community health outcomes.

This webcast will give you inspiration and a clear view on your next steps in regulatory strategy and implementation. We hope to see you there.