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Jun 14
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09:00 - 09:10

Opening remarks from the Chairperson

Showing of Streams
10:55 - 11:25

Morning coffee and networking break

Showing of Streams
12:35 - 14:00

Networking lunch

Showing of Streams
15:10 - 15:40

Afternoon tea and networking break

Showing of Streams
17:50 - 17:55
End of conference day four

End of conference day four

09:00 - 09:10 10 mins
Opening remarks from the Chairperson
09:10 - 09:45 35 mins
Sterilisation and Reprocessing of Medical Devices
Understanding the impact of the EU Medical Device Regulation (MDR) on sterilisation processes
  • Jeff Vest - Principal Specialist – MHS (Technical Reviewer), TÜV SÜD Product Service, UK
more
  • Discussing how the new EU MDR will impact sterilisation processes
  • Outlining how any changes to sterilisation processes will be implemented
  • Examining how the new EU MDR will impact sterilisation processes for different users, including hospitals
  • Reviewing how existing harmonised standards are being revised and new standards developed in line with the EU MDR, and how this impacts sterilisation and packaging
09:10 - 09:45 35 mins
Drug Device Combination Products
Notified Body Perspective: Practically implementing new requirements of the EU MDR for drug device combination products (DDCPs)
  • Daniel Shoukier - Lead Auditor, SQS, Switzerland
more
  • Highlighting the impact of the changes in classification on combination products
  • Exploring the increased clinical data requirements of the EU MDR
  • Assessing the implications the EU MDR will have on Notified Bodies and the effect this will have on combination product manufacturers
  • Sharing lessons learned since the release of the EU MDR
09:10 - 09:45 35 mins
IVD Regulatory and Strategic Forum
Practically implementing the IVDR: Competent Authority perspective
  • Stephen Lee - Senior Regulatory Policy Advisor - IVDR, MHRA, UK
more
  • Exploring strategies Competent Authorities are employing to prepare for the IVDR
  • Highlighting the changes in Competent Authority procedures following the IVDR
  • Discussing the issues and opportunities Competent Authorities are facing due to the IVDR
  • Updates on the progress of Implementing Acts and Delegating Acts
09:10 - 09:45 35 mins
Medical Device Regulatory Affairs in Emerging Markets
Shedding light on Russian requirements for manufacturing site inspections
  • Maria Bogorad - Regulatory, Quality & Continuous Improvement, Johnson & Johnson Medical, Russia
more
  • Clarification of existing and upcoming requirements of Russian and Eurasian Economic Union (EAEU) site inspections
  • Guidance on how to properly prepare for site inspections
  • Discussion of the implementation and features of a common EAEU site inspection
09:45 - 10:20 35 mins
Sterilisation and Reprocessing of Medical Devices
Latest updates on national implementation of reprocessing single-use devices and implications of Common Specifications for industry
  • Dan Vukelich - President, Association of Medical Device Reprocessors (AMDR), USA
more
  • Exploring the positions and statuses of different Member States on reprocessing
  • Discussing reprocessing requirements in the MDR
  • Examining Common Specifications used in the area of reprocessing single-use devices
  • Outlining how industry handle reprocessing and key challenges and concerns
09:45 - 10:20 35 mins
Drug Device Combination Products
Industry Perspective: Practically implementing new requirements of the EU MDR for drug device combination products
  • Hilde Viroux - Global Head EU MDR Compliance, Alcon, USA
more
  • How to start: what steps to take to begin implementing the new requirements of the EU MDR for DDCP manufacturers
  • Discussing best strategies for performing gap assessments
  • Exploring what makes successful pilot studies under the new EU MDR
09:45 - 10:20 35 mins
IVD Regulatory and Strategic Forum
Practically implementing the IVDR: Notified Body perspective
  • Nick Baker - IVD Technical Manager, LRQA, UK
more
  • Clarifying procedures in selecting and working with Notified Bodies
  • Resource catastrophe – are there enough Notified Bodies to go around?
  • Understanding the processes undertaken by Notified Bodies in auditing manufacturers
  • Discussing strategies Notified Bodies are using to meet new requirements under the IVDR
  • Tips for companies moving from being self-certified to working with Notified Bodies
09:45 - 10:20 35 mins
Medical Device Regulatory Affairs in Emerging Markets
Understanding the Russian Federation government procurement system and the implications for industry
  • Yana Prus-Galynsky - CEO, Zephyr Biomedical, Israel
more
  • Clarifying the Russian medical device public procurement tender law and the “third one out” bid system
  • Exploring the requirements for medical devices to be considered locally produced
  • Discussing strategies for foreign manufacturers to best deal with the tender laws
10:20 - 10:55 35 mins
Sterilisation and Reprocessing of Medical Devices
Exploring new and existing requirements for reprocessing of devices for sterile use
  • Hagen Thielecke - Director R&D, Vanguard AG, Germany
more
  • Implementation of conform reprocessing processes and validations
  • Existing national and European standers and guidelines related to reprocessing
  • Demand for new standards and common specifications for reprocessing
  • Discussing the assessment of potential clinical risks based on biological data
  • Peculiarities in case of reprocessing of single use devices
  • Adherence to IS0 11113:2014
10:20 - 10:55 35 mins
Drug Device Combination Products
EU MDR Rule 21: Evaluating the impact on substance-based devices
  • Jörg Plessl - Director EU Affiliates, Regulatory Affairs, Norgine, Germany
more
  • Clarifying the requirements due to Rule 21 on substance-based devices
  • Understanding the demarcation between substance-based medical devices and combination products
  • Exploring the impacts of the higher classification of substance-based devices
  • Evaluating the impact of the increased costs and stricter procedures on the industry due to the new EU MDR Rule 21
10:20 - 10:55 35 mins
IVD Regulatory and Strategic Forum
INTERACTIVE PANEL: Working with Notified Bodies and Competent Authorities to meet IVDR requirements
  • Stephen Lee - Senior Regulatory Policy Advisor - IVDR, MHRA, UK
  • Nick Baker - IVD Technical Manager, LRQA, UK
  • Sue Spencer - Head of Global Medical Device Services, UL, UK
  • Catherine Holzmann - Certification Division Manager In Vitro Diagnostics, LNE/G-MED, France
  • Simon Richards - VP Regulatory Affairs, Alere, UK
more
  • Updates on the progress of implementing the IVDR
  • Clarifying the expectations Notified Bodies and Competent Authorities have for manufacturers
  • Highlighting the issues being faced due to the IVDR
  • Discussing how to select a Notified Body
  • How to prepare for audits
10:20 - 10:55 35 mins
Medical Device Regulatory Affairs in Emerging Markets
Safety monitoring: Best practises for successfully conducting post-market surveillance in Russia
more
  • Highlighting the updates to new monitoring requirements by Russian medical device authorities
  • Discussing the impacts and new challenges these may bring
  • Identifying strategies for implementing monitoring requirements
10:55 - 11:25 30 mins
Morning coffee and networking break
11:25 - 12:00 35 mins
Sterilisation and Reprocessing of Medical Devices
Exploring new EU MDR requirements for classification of class I reusable medical devices
  • Jeff Vest - Principal Specialist – MHS (Technical Reviewer), TÜV SÜD Product Service, UK
more
  • Understanding what requirements are in place for the classification of class I reusable medical devices
  • Reviewing increased Notified Body involvement in the conformity assessment of these products
  • Examining what is expected in terms of sterilisation and packaging
  • Overcoming key challenges and ensuring preparation for these new requirements
11:25 - 12:00 35 mins
Drug Device Combination Products
Understanding the requirements for biocompatibility as outlined in ISO 10993 for drug device combination products
  • Clemens Günther - Director Nonclinical Safety, Bayer, Germany
more
  • Clarifying the requirements for biocompatibility in combination products according to ISO 10993
  • Understanding the implications for combination product manufacturers from ISO 10993
  • Knowing when further studies are needed to ensure a combination product’s compliance
11:25 - 12:00 35 mins
IVD Regulatory and Strategic Forum
Practically implementing the IVDR: Industry perspective
  • Simon Richards - VP Regulatory Affairs, Alere, UK
more
  • Identifying the differences between the MDR and the IVDR
  • Discussing strategies for implementing the new requirements
  • Assessing when manufacturers should begin implementing changes
  • Practical examples of effectively preparing for the IVDR
  • Understanding the expectations of Competent Authorities and Notified Bodies
11:25 - 12:35 70 mins
Medical Device Regulatory Affairs in Emerging Markets
EXTENDED INTERACTIVE SESSION: Practical guidance on successfully registering medical devices in Russia
  • Chris Dark - Head of Regulatory Affairs, Arkray Factory Ltd, UK
  • Marina Semenova - QA Manager, Arkray ooo, Russia
more

A case study from industry followed by a collaborative discussion.

  • A step-by-step walkthrough of the procedures of registering medical devices in Russia
  • Sharing experiences with strategies for bringing products to the Russian market
  • Exploring the expectations of Russian regulatory authorities
  • Requirements of technical documentation for medical devices
  • Contacting and working with Russian hospitals for clinical trials
12:00 - 12:35 35 mins
Sterilisation and Reprocessing of Medical Devices
The MDR requires evidence regarding the qualification and competency of personnel in sterilization – how is the Medical Device industry going to achieve this?
  • Arthur Dumba - Medical Device Sterilization Consultant, International Irradiation Association (iia), Switzerland
more
  • The MDR and requirements regarding qualification, selection and authorisation of sterilisation personnel
  • Certification and Qualification of sterilisation personnel in their respective technology
  • Global harmonisation of certification and qualification of sterilization personnel
  • Maintenance of certification and qualification of sterilization personnel
12:00 - 12:35 35 mins
Drug Device Combination Products
Drug-device compatibility: Where is the guideline?
  • Lise Vanderkelen - Department Head Pharma Services, Toxikon Europe, Belgium
more
  • Interaction of drugs with materials
  • Analytical testing
  • Case studies
12:00 - 12:35 35 mins
IVD Regulatory and Strategic Forum
Understanding the new classification system for IVDs under the IVDR
  • Mark Thomson - Head of Medical Device and Equipment Team, Global Regulatory Management, Merck, UK
more
  • Clarifying the differences between the IVDD and IVDR classification systems
  • Examining what the new classification system means for IVD manufacturers
  • Identifying how products fit into the new classification system
  • Exploring steps manufacturers can take to update their classification of products
12:35 - 14:00 85 mins
Networking lunch
14:00 - 14:35 35 mins
Sterilisation and Reprocessing of Medical Devices
Case study: Best practice for successfully carrying out Ethylene Oxide (EO) sterilisation
  • Jan Douglas - Engineering Manager, Cook Medical, Denmark
more
  • Exploring the pros and cons of EO sterilisation
  • Reviewing the challenges and best practices of performing EO sterilisation validation
  • Success stories and case examples
14:00 - 14:35 35 mins
Drug Device Combination Products
CHMP Meetings: How to prep for, manage and excel at these EU regulatory meetings
  • Bert Regeer, MD - Senior Scientific Lead, 3D Communications, USA
more
  • Understand the EMA review timeline
  • Learn how to prepare for the four different types of CHMP meetings you may face (Expert Group meeting, Scientific Advisory Group (SAG) meeting, Oral Explanation, and PRAC meeting)
  • Be introduced to the technology and support needed to successfully manage Q&A in the meetings
14:00 - 14:35 35 mins
IVD Regulatory and Strategic Forum
New requirements of clinical evidence under the IVDR
  • Sue Spencer - Head of Global Medical Device Services, UL, UK
more
  • Clarifying the new requirements for clinical evidence under the IVDR
  • What to take into consideration when designing studies under the new regulations
  • What is an interventional study? What are invasive procedures in regards to IVD performance evaluation?
  • What impact will the new clinical evidence requirements have on all stakeholders
14:00 - 14:35 35 mins
Medical Device Regulatory Affairs in Emerging Markets
Updates on the progress of the Eurasian Economic Union (EAEU) regulations and the impact on industry
  • Alexey Stepanov, Russia
more
  • Updates on the progress and timelines of the implementation of a common regulatory system across the EAEU
  • Clarifying the differences between this common system and the existing regulations in EAEU member countries
  • Exploring the impact the new regulations will have on medical device companies working or planning to work in the EAEU
  • Discussing the potential benefits of a common market for exporters to the EAEU
14:35 - 15:10 35 mins
Sterilisation and Reprocessing of Medical Devices
Exploring Ethylene Oxide (EO) residual testing per ISO 10993-7
  • Pamela Barrows - Director, Controlled Environments and Sterilization Control, Getinge Group, USA
more
14:35 - 15:10 35 mins
Drug Device Combination Products
Updates on Canadian regulation of drug device combination products
  • Douglas Watson - Senior Policy Analyst, Health Canada, Canada, subject to final confirmation
more
14:35 - 15:10 35 mins
IVD Regulatory and Strategic Forum
Implications of the IVDR clinical evidence requirements on legacy products
  • Maurizio Suppo - Vice President Regulatory Affairs, QARAD, Italy
more
  • Exploring the impact the IVDR requirements for clinical data will have on existing IVD products
  • Assessing whether legacy products should be brought to new requirements or discarded
  • Practical guidance on supporting legacy products going into the IVDR
14:35 - 15:10 35 mins
Medical Device Regulatory Affairs in Emerging Markets
Understanding labelling requirements for medical devices in Russia
  • Bulat Magdiev - Regulatory Associate, RB, Russia
more
  • Clarifications on the expectations of Russian authorities for medical device labelling
  • Outlining the differences between the valid standards in Russia and the EAEU
  • Discussing how to assess products to ensure correct labelling
15:10 - 15:40 30 mins
Afternoon tea and networking break
15:40 - 16:15 35 mins
Sterilisation and Reprocessing of Medical Devices
Case study: Exploring sterilization validation approaches for Gamma and ETO sterilization
  • Bjoern Wiese - Director Sterilization Technology and Analytical Testing EMEA, Zimmer Biomet, Switzerland
more
  • Reviewing challenging validations that have arisen
  • Discussing how these challenges were overcome
  • Success stories
15:40 - 16:15 35 mins
Drug Device Combination Products
Updates from the FDA on new regulations regarding drug device combination products
  • John "Barr" Weiner - Associate Director, Combination Products Office, FDA, USA
more
  • Outlining recent updates and changes to FDA combination products regulations
  • Exploring the impact of the 21st Century Cures Act on the combination products industry
  • Discussing recent FDA guidances such as the Digital Health Innovation Plan and the implications for combination products
15:40 - 16:15 35 mins
IVD Regulatory and Strategic Forum
INTERACTIVE ROUND TABLE SESSION: Sharing experience with increased clinical evidence requirements under the IVDR
  • Chris Weatherall - Senior Director Quality Assurance & Regulatory Affairs, Meridian Bioscience Inc., UK
more
  • What steps are manufacturers taking?
  • Can existing data be used to bring existing products to new requirements?
  • What will happen to the IVD products already on the market?
  • How to reduce the costs associated with the new clinical evidence requirements
15:40 - 16:15 35 mins
Medical Device Regulatory Affairs in Emerging Markets
Practically exploring updates to medical device regulations in Kazakhstan
  • Yana Prus-Galynsky - CEO, Zephyr Biomedical, Israel
more
  • Outlining updates to the medical device registration procedures in Kazakhstan
  • Understanding the rules and requirements of quality management system inspections
  • Guidance on working with the Kazakhstan authority
16:15 - 16:50 35 mins
Sterilisation and Reprocessing of Medical Devices
Exploring latest updates to the Radiation Sterilization standard ISO 11137 and implications for industry
  • Arne Miller - Professor, Risø High Dose Reference Laboratory, Denmark
more
  • Reviewing suggested amendment to 11137-1 modifying release criteria
  • Reviewing recent changes to ISO 11137-3 (Guidance on dosimetric aspects of development validation and routine control)
  • Exploring upcoming changes and timelines for ISO 11137-4 (Guidance on process control)
  • Understanding how these changes impact industry including how to measure and use uncertainties
  • Overcoming key challenges with practically implementing these standards
16:15 - 16:50 35 mins
Drug Device Combination Products
Practically approaching the US FDA GMP guidelines for combination products
more
  • Clarifying the new FDA GMP regulations for combination products
  • Exploring effective GMP strategies for combination product manufacture
  • Discussing the challenges faced by combination product manufacturers in conforming to GMP guidelines
16:15 - 16:50 35 mins
IVD Regulatory and Strategic Forum
Overview and updates to EUDAMED and implications to IVDs
  • Céline Bourguignon - Chair of the MedTech Eudamed Taskforce, MedTech Europe, Belgium
more
  • Clarifying what will be included in the EUDAMED database, how it will be used, and what IVD manufacturers will need to do
  • Updates on the status of EUDAMED: which modules have been completed and which are still being worked on
  • Examining the effects EUDAMED will have on the IVD industry
16:15 - 16:50 35 mins
Medical Device Regulatory Affairs in Emerging Markets
The adoption of an EU Medical Device Directive (MDD)-based regulation system in Ukraine
  • Alexander Schapovalov - Foreign Affairs Manager, TÜV SÜD, Germany
more
  • Exploring what a regulatory system almost identical to the EU MDD in the Ukraine will mean for the industry
  • Highlighting the difference between CE marks and Ukraine’s conformity mark
  • Considering what this will mean for companies wanting to expand out of the EU market
16:50 - 16:55 5 mins
Sterilisation and Reprocessing of Medical Devices
End of Conference Day Four
16:50 - 17:25 35 mins
Drug Device Combination Products
Comparing EU MDR and US FDA drug device combination product regulations to identify effective regulatory strategies
  • Winifred Wu - President and Principal Advisor, Strategic Regulatory Partners, USA
more
  • Identifying the similarities and difference of EU MDR and US FDA regulations for combination products
  • Discussing how borderline products are classed in the EU compared to the US
  • Highlighting differences faced by pharmaceutical manufacturers for drug device combination products between the EU and the US
  • Exploring how to create effective strategies for drug and device manufacturers to ensure compliance in both EU and US markets
16:50 - 17:25 35 mins
IVD Regulatory and Strategic Forum
Unique Device Identifiers (UDI) requirements for IVDs
  • Melissa Finocchio - Project Portfolio Leader, Global Quality, bioMérieux, France
more
  • Discussing the impact of the IVDR UDI requirements
  • Understanding the differences between EU and US UDI requirements: can both systems be combined for one package?
  • Exploring experiences and challenges in implementing UDIs from a manufacturer’s perspective
16:50 - 17:50 60 mins
Medical Device Regulatory Affairs in Emerging Markets
The Product Tracking System (UTS): Turkey’s new registration database and other upcoming changes
  • Ilker Yilmaz - Regulatory Affairs & Market Access Manager, Meril, Turkey
more
  • Exploring the impact of the transition from Turkey’s National Information Bank of Medicine and Medical Devices (TITUBB) to the UTS
  • Highlighting the key changes from the UTS and other regulatory updates
  • Discussing the other upcoming changes and their impacts
17:50 - 17:55 5 mins
End of conference day four