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Day One – 10 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
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Day One – 10 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
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Medical Device Law and Compliance
09:00 - 09:10
Chairperson’s Opening Remarks: Medical Device Law and Compliance
- Hilary Jones - Senior Director, Legal Pharmaceutical Regulation, BioNTech UK Limited
09:10 - 09:40
DUAL DIALOGUE What does the Artificial Intelligence (AI) Act Mean for Medical Devices and IVDs
- Reconciling the requirements in the IVD, MDR and guidance under the umbrella of the proposed AI Act?
- Considerations for users of AI Systems as the proposed AI Act extends to users
- Overlaying European proposals with US frameworks for AI and the implications for global policies
- Practical implications and legal considerations for MedTech and IVD manufacturers
- Agnes Szoboszlai - Regulatory Legal Counsel, Philips
- Sarah Cowlishaw - Partner, Covington & Burling LLP
09:40 - 10:10
DUAL DIALOGUE Navigating Data Frameworks and European Health Data Space (EHDS)
- Analysing crucial legal frameworks influencing your data landscape: delving into the EHDS, the Digital Data Act, and the Data Act
- Navigating the EHDS: unveiling challenges and opportunities for the MedTech and IVD industry and lessons from the pharmaceutical industry
- What types of data are appropriate for inclusion in EHDS and where should the line be drawn for commercially sensitive data?
- Safeguarding commercially confidential data: assessing the adequacy of Intellectual Property (IP) protection in the ever-evolving data landscape
- Roberto Girardi - Senior Director, Global Head of Privacy Compliance & Risk Management, ResMed
- Nathalie Poupaert - Counsel, Technology & Data, Fieldfisher
10:10 - 10:40
DUAL DIALOGUE Decoding the Impact of Enhanced Cyber Security Regulations for Medical Devices and IVDs
- Overview of regulatory frameworks: Cyber Resilience Act (CRA), NISD2, and Critical Entities Resilience Directive (CER)
- Analysis of implications for internet-enabled devices
- Strategic guidance on navigating the heightened regulatory burden imposed by new regimes including the US cyber security rules
- Alison Dennis - Partner, Taylor Wessing
- Paula Antunes - Global Regulatory Lead, GRA - RA Digital Health & IVD, Novo Nordisk
Showing 1 of 1 Streams
Medical Device Law and Compliance
11:10 - 11:40
DUAL DIALOGUE Where to Launch? Comparison of EU CE Mark with UK CA and the Swiss CE Label
- Review of UK CA mark: when might it be advantageous to certify in the UK? Considerations for software and existing legacy MDD certified devices
- Implications of the UK move to join MDSAP
- New international recognition regimes in the UK extending to approvals in the US, Japan and other countries
- Examining the effects of the Swiss foreign recognition pathway
- Darren Thain - Director, Global Regulatory Affairs Policy and Intelligence, Smith & Nephew
- Alex Denoon - Partner, Bristows LLP
11:40 - 12:10
DUAL DIALOGUE Advantages and Challenges of UK Innovative Device Alternative Pathway (IDAP)
- UK framework to accelerate the development and deployment of innovative medical devices
- Developments for Mutual Recognition Agreements
- How will the MHRA approach issuing temporary approvals?
- Legal (including IP) considerations for regulatory submissions and pricing authority approvals
- Opportunities and disadvantages of IDAP when considering where to launch
- Will the EU Commission adopt a similar framework in the planned revision of MDR and IVDR?
- Roshni Kasturi - Clinical Lead, MDR/IVDR, Ascensia Diabetes Care
- Alex Denoon - Partner, Bristows LLP
12:10 - 12:40
DUAL DIALOGUE The Liability Risks and Implications of Regulatory Failings
- Examining the current state of play in product liability litigation
- Regulatory failings as evidence of product defect
- How changes to the existing regulatory frameworks might give rise to an increased liability risk
- Samantha Silver - Partner, Kennedys
- Nathalie Smyth - Partner, Kennedys
Showing 1 of 1 Streams
Medical Device Law and Compliance
14:10 - 14:15
Chairperson’s Afternoon Remarks: Medical Device Law and Compliance
- Hilary Jones - Senior Director, Legal Pharmaceutical Regulation, BioNTech UK Limited
14:15 - 15:15
DUAL DIALOGUE IVDR Developments for Companion Diagnostics: From Clinical Trials and Regulatory Approval to Reimbursement
- Understanding IVDR regime for companion diagnostics
- Reconciling the requirements of IVDR and the EU Clinical Trials Regulation
- Commercial and IP considerations when pharmaceuticals are combined with devices and companion diagnostics
- Practical challenges of reimbursement for companion diagnostics
- Josefine Sommer - Partner, Sidley Austin
- Ioana Ratescu - Head Legal Global Regulatory, Novartis
15:15 - 15:45
DUAL DIALOGUE Legal Recourse: What to Do When your Competitor Breaks the Rules
- Different areas of focus and best options including EU MDR accountability, Industry Codes of Conduct, Freedom of Information requests and Notified Bodies
- Challenging competitor CE Marks based on non-compliance and safety concerns: interacting with Notified Bodies, Competent Authorities, customers and Courts
- Competition Law considerations in light of ongoing Commission investigations regarding allegations of abuse of dominance
- Practical case scenarios and worked examples
- Michele Boggiani - Director, Global Legal Lead, Galderma
- Jacqueline Mulryne - Partner, Arnold & Porter
Showing 1 of 1 Streams
Medical Device Law and Compliance
16:15 - 16:45
Preparing for the European Product Liability Directive
- How will the EU’s Product Liability Directive 85/374/EEC sit alongside new laws on the liability of AI systems and the new class action mechanism
- How will key changes affect the MedTech industry and strategies to ensure you are prepared
- Analysing liability for importers, authorised representative, manufacturers
- Interpreting the new expanded definition of defect
- Fabien Roy - Partner, Hogan Lovells
16:45 - 17:45
DUAL DIALOGUE Legal Advice and Avoiding Common Trip Points for Medical Device Commercial Transactions
- Practical advice on how to prepare for an M&A transaction: considerations for buyers and sellers
- Sharing best practice and common mistakes in M&A transactions in the MedTech sector
- Examining the restrictions imposed by the Article 120 transitional provisions
- Implementation considerations including changing economic operators and PRRCs
- Annabelle Bruyndonckx - Partner, Simmons & Simmons LLP
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