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Innovate: The MedTech Series – The EU (European Union) AI Act Training Course

What does it mean for the pharmaceutical and medical device industry?

Lunch & Learn

This session will summarise the EU AI Act and its implications on the healthcare sector, including how to be compliant with the new regulatory framework.

3 April 2025
+ 2 October 2025 »

from £175

Need help?  Enrol/reserve

Part of Lunch & Learn: Innovate – The MedTech Series series:

This series will explore recent innovations and regulations within the MedTech space, such as digital health innovations and the 2024 AI Act. In a rapidly changing field, join us to hear from the experts before anyone else does!

What is Lunch & Learn? Turn your lunch hour into a valuable learning opportunity with our all-new Lunch & Learn category – an exciting twist on the traditional webinar, starting in 2025. These bite-sized, budget-friendly and diverse training sessions are designed to fit seamlessly into your working day, providing a flexible and impactful way to advance your skills without disrupting your busy schedule.

If you’re looking to boost your professional expertise, our Lunch & Learn courses combine the latest insights, expert-led instruction, and practical tools to keep you engaged and evolving — all in the time it takes to enjoy your lunch!

So, what are you waiting for? Learn something new, grow your career, and make every minute count.

From £99! Our Lunch & Learn short courses start from just £99 (early booking price) when you book 5 or more places - any combination of multiple courses for one attendee, or multiple attendees on the same course.

Overview

In August 2024, the European Union (EU) approved the Artificial Intelligence (AI) Act, the first legislation aimed at regulating AI applications whilst protecting EU citizens from the potential harms of AI. The regulation will take effect on 2nd August 2026 and will have a significant impact on the healthcare sector.

Legislative changes are also afoot across the globe. In the US, the FDA continues to update its guidance on AI-enabled device software. For example, in December 2024, the FDA published new guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for AI-Enabled Device Software Functions to provide a reasonable assurance of device safety and effectiveness  Conversely, Asia-Pacific has adopted a light touch and voluntary approach to AI regulation, some jurisdictions like China have taken a more prescriptive approach.  

According to a recent survey from Norstella, 66% of biopharma organisations say the skills required for their employees have changed due to the introduction of AI. Over 70% of industry leaders confirmed the main reason behind its limited adoption is a lack of expertise, followed by a lack of knowledge/awareness of AI and what it can do to improve pharmaceutical R&D processes (43%). This session will summarise the European AI Act and its implications on the healthcare sector and what provisions and assessments organisations may need to put in place to be compliant with the new regulatory framework.

Key topics covered in this exciting talk include:

  • An overview of the AI Act, the EU’s Coordinated Plan on Artificial Intelligence, and its potential impact on the healthcare sector
  • A look at what constitutes a high-risk AI system and provide examples of where this might impact the pharmaceutical drug development and medical device commercialisation strategy
  • Discuss the minimum information regulators will require for Fundamental Rights Impact Assessments (FRIAs) and Data Protection Impact Assessments (DPIAs) and what measures organisations need to put in place to ensure they are fully compliant with the protection of personal data

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Benefits of attending

This course provides greater clarity on the potential impact of the AI Act on pharmaceutical and medical device organisations and brings stakeholders up to speed on what constitutes high-risk AI systems. By joining, you will: 

  • Review the definition of AI and high-risk AI systems and provide real case studies where high-risk AI systems are utilised by pharmaceutical companies in the drug development process and medical device manufacturers in product development
  • Gain a greater understanding of what the AI Act covers and what provisions and assessments organisations may need to conduct to be fully compliant with the new regulations
  • Explore the implication of the EU AI Act on data protection and privacy and review the similarities/differences and information requirements for Fundamental Rights Impact Assessment (FRIA) and Data Protection Impact Assessment (DPIA) that organisations need to adhere to remain compliant

Who should attend?

This course is designed for a diverse audience. Whether you're a healthcare professional, a policymaker, or interested in how the EU AI Act will impact the healthcare sector, this course will offer you valuable insights.

Enrol/reserve

Cheryl Barton
PharmaVision

Dr Cheryl L Barton is an independent consultant with over 35 years' research and business analysis experience. Following her senior research positions in academia and seven years with Merck, in which she was responsible for a variety of CNS research projects. Dr Barton joined Dutch investment bank ABN Amro NV as a senior equity analyst to provide coverage on pan-European companies and assessed the potential impact of new drug development on European Stocks. In 2002, Dr Barton founded PharmaVision to provide independent, tailor-made, life science and consumer health research to pharmaceutical companies, competitive intelligence specialists, investment institutions, and healthcare communication agencies. Dr. Barton regularly writes articles for Pharmtech regarding the latest advances in scientific technologies and regulatory issues that impact the Biopharma and MedTech industries.

More details

3 April 2025

Lunch & Learn

Live online

12:00-13:30 UK (London) (UTC+01)
13:00-14:30 Paris (UTC+02)
07:00-08:30 New York (UTC-04)
Course code 15536

  • GBP 175 200
  • EUR 245 280
  • USD 280 320

Until 27 Mar

View basket 

 
Not ready to book yet?

for 7 days, no obligation

2 October 2025

Lunch & Learn

Live online

12:00-13:30 UK (London) (UTC+01)
13:00-14:30 Paris (UTC+02)
07:00-08:30 New York (UTC-04)
Course code 15537

  • GBP 175 200
  • EUR 245 280
  • USD 280 320

Until 25 Sep

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy