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Jun 15
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09:00 - 09:10

Opening remarks from the Chairperson

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Showing of Streams
10:55 - 11:25

Morning coffee and networking break

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Showing of Streams
12:35 - 14:00

Networking lunch

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Showing of Streams
15:10 - 15:40

Afternoon tea and networking break

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Showing of Streams
16:15 - 16:20
End of conference day five

End of conference day five

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09:00 - 09:10 10 mins
Opening remarks from the Chairperson
09:10 - 09:45 35 mins
Info
Sterilisation and Reprocessing of Medical Devices
Moving from the MDD to the MDR – what will be the impact on sterile packaging, including latest status updates to ISO 11607 – Packaging for terminally sterilized medical devices
  • Thierry Wagner - Regulatory Affairs Director - Europe, Middle-East & Africa, DuPont Medical and Pharmaceutical Protection, Luxembourg
  • Analysis of key differences between essential requirements in annex I of the MDD and general safety and performance requirements of annex I of the MDR
  • Latest status update, upcoming changes and timelines to EN ISO 11607 to be harmonized with the MDR
  • Understanding how changes to EN ISO 11607 will impact industry
09:10 - 09:45 35 mins
Info
Drug Device Combination Products
Practically overcoming regulatory and practical challenges with the design, manufacture, and distribution of pre-filled injection devices – competent authority perspectives
  • Ann Jans - Medical Devices Quality Assessor, FAMHP, Belgium
  • An overview of the regulatory requirements related to the design, manufacture, and distribution of pre-filled syringes
  • Guidance on how to successfully achieve market authorisation for pre-filled syringes
  • Exploring the impacts of the EU MDR on pre-filled syringes
  • Highlighting end-user considerations drug and device manufactures need to make in terms of usability
09:10 - 09:45 35 mins
Info
IVD Regulatory and Strategic Forum
Clarification of the role of the Person Responsible for Regulatory Compliance (PRRC) under the IVDR from a practical standpoint
  • Paolo Mellino - IVDR Manager, Abbott, Germany
  • Understanding the role and responsibilities of the PRRC
  • How to implement the IVDR: filling the role of the PRRC
  • Identifying what makes good compliance and the steps involved in the process
  • Discussing the impact the requirements under the IVDR for a PRRC will have on the IVD industry
09:10 - 09:45 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
ANVISA perspective: Understanding the latest regulatory framework in Brazil and the implications for industry
  • Augusto Geyer - Deputy General Manager, Medical Devices Office, ANVISA, Brazil
  • Discussing changes and new additions to ANVISA’s medical device regulations
  • Exploration of the impact of Technical Note 004 on clinical evaluation
  • Examining the impacts of the extended validity timeframes for medical device registration
09:45 - 10:20 35 mins
Info
Sterilisation and Reprocessing of Medical Devices
Case study: handling sterile packaging waste
  • Karina Engels - Product Manager Sterilisation & InteguSeal EMEA, Halyard Health, Belgium
  • Handling sterilization packaging waste: current status
  • Outcome of a sterilization wrap collection project
  • Conclusions and feasibility
09:45 - 10:20 35 mins
Info
Drug Device Combination Products
Practically approaching the co-development of drug and device components of drug device combination products
  • Sanjay Jain - Drug Delivery Systems Principal Engineer, Janssen, USA
  • Guidance on coordinating between the different regulatory requirements between devices and drugs
  • Identifying effective strategies for partnering between pharmaceuticals and device manufacturers
  • Practical advice on conducting clinical trials incorporating both the drug and device components of combination products
09:45 - 10:20 35 mins
Info
IVD Regulatory and Strategic Forum
The effects the IVDR will have on economic operators
  • Chris Dark - Head of Regulatory Affairs, Arkray Factory Ltd, UK
  • Highlighting the impact of the IVDR on economic operators
  • Understanding the new requirements on importers and distributors due to the IVDR
  • Assessing the challenges and opportunities created by this change
  • Manufacturers perspective of how to implement these new requirements
09:45 - 10:20 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Case study: How to pass the ANVISA GMP audit
  • Gloria Schneider-Ferrer - Manager, Global Strategy - Brazil, DePuy Synthes, Switzerland
  • An industry perspective on the expectations and procedures of ANVISA
  • Guidance on implementing GMP requirements
  • Identifying the best methods to prepare for unexpected audits
10:20 - 10:55 35 mins
Sterilisation and Reprocessing of Medical Devices
Global sterility assurance challenges and opportunities
  • Byron Lambert - Sr Assoc Fellow, Sterilization, Abbott Vascular, USA
10:20 - 10:55 35 mins
Info
Drug Device Combination Products
Considerations for how increased clinical data requirements as proposed in the EU MDR impacts combination products
  • Florian Tolkmitt - Independent Regulatory Affairs and Clinical Evaluation Expert, Germany
  • Clarifying what the MEDDEV 2.7/1 revision 4 for clinical evaluation means for combination products
  • Exploring how and when the addition of a device affects existing clinical data for a drug
  • Identifying how drug and device components of combination products can be separately affected by increased clinical data requirements
10:20 - 10:55 35 mins
Info
IVD Regulatory and Strategic Forum
New requirements of post-market surveillance under the IVDR
  • Gary Carpenter - Director of Clinical and Regulatory Affairs, BioSure, UK
  • Understanding of what exactly is required for post-market surveillance
  • Discussing how to generate post-market clinical data per IVDR guidelines
  • Evaluating how the new requirements of post-market surveillance will impact economic operators
  • Practical examples of effective post-market surveillance from the medical devices industry
10:20 - 10:55 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
MDSAP pilot update: The impact of the MDSAP on the Brazilian regulatory environment
  • Georg Bauer - Department Manager Regulatory Affairs, TÜV SÜD, Germany
  • Investigating the impact the MDSAP implementation will have on regulatory frameworks in Brazil
  • Highlighting the differences between the MDSAP audits and ANVISA audits
  • Understanding when the MDSAP audits can replace ANVISA audits
10:55 - 11:25 30 mins
Morning coffee and networking break
11:25 - 12:00 35 mins
Info
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
  • 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
11:25 - 12:00 35 mins
Info
Drug Device Combination Products
An overview of recent changes and updates in human factors engineering standards and guidance and the implications for drug-device combination products
  • Molly Story - Senior Director, Global Usability Engineering and Risk Management, Sanofi, USA
  • Describing international standards (ISO, IEC) that involve human factors engineering for medical devices
  • Describing national guidance documents (FDA, MHRA) that involve human factors engineering for medical devices
  • Discussing the implications of these new documents for drug-device combination products
11:25 - 12:00 35 mins
Info
IVD Regulatory and Strategic Forum
Comparing US and EU regulatory requirements for IVDs
  • Carol Lindsay - Senior Regulatory Scientist, Promega, USA
  • Exploring the differences in IVD regulatory requirements between the US and the EU
  • Sharing experiences in effectively updating IVD products to new regulations
  • Discussing the impacts of the IVDR in terms of bringing products to an international market
11:25 - 12:00 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Review of updates to INMETRO certification requirements: How to ensure compliance
  • Luciano Oliveira Ferreira - Head of Quality & Regulatory Affairs, QA/RA Works, Brazil
  • Most recurrent NC on the INMETRO audit
  • A suggestive flowchart of INMETRO regulatory procedures
  • Evaluating the impact of Ordinance 54/2016 for Brazilian certified medical devices
12:00 - 12:35 35 mins
Info
Sterilisation and Reprocessing of Medical Devices
Understanding the liquid sterilisation of medical devices with derivatives of animal origin
  • Wilhelm Erdbrügger - Sen. Manager Process Development, BIOTRONIK, Switzerland
  • Exploring different methods and strategies
  • Reviewing virus inactivation and sterilisation validation
  • Overcoming key challenges experienced
12:00 - 12:35 35 mins
Info
Drug Device Combination Products
INTERACTIVE SESSION: A hands-on exploration of human factors testing for combination products
  • Echo Kirk - Managing Human Factors Specialist, UL, Netherlands
  • Linda Giesselink - Senior Human Factors Specialist, UL, Netherlands

An introduction to human factors testing for combination products followed by an interactive usability test workshop.

  • A brief overview of the requirements and expectations for human factors testing of combination products
  • Clarifying the processes involved in effectively integrating human factors into combination product design
  • Interactive guidance on performing market usability testing for drug device combination products
12:00 - 12:35 35 mins
Info
IVD Regulatory and Strategic Forum
The impacts of the IVDR for companion diagnostics manufacturers
  • Alex Laan - Principal Certification Manager, Dekra Certification BV, Netherlands
  • Clarification of the new requirements for companion diagnostics under the IVDR
  • How to adapt from being mostly self-certified to requiring Notified Body intervention
  • Discussing procedures companion diagnostics manufacturers need to take to meet these new requirements and when these procedures need to be started
  • Practical examples of effectively implementing the new requirements
12:00 - 12:35 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Updates to COFEPRIS regulations in Mexico and guidance for implementation
  • Ana Luisa Fritschy - Manager Regulatory Affairs, Aptar Stelmi, France
  • Understanding the requirements of COFEPRIS for medical device registration
  • Examining recent changes to COFEPRIS medical device regulations
  • Exploring implementation strategies for bringing a product to Mexico
12:35 - 14:00 85 mins
Networking lunch
14:00 - 14:35 35 mins
Info
Sterilisation and Reprocessing of Medical Devices
Exploring sterilisation techniques for 3D printed products
  • James McCoy - Staff Quality Scientist, Global Sterilization Research and Innovation, BD, USA
  • Discussing what sterilisation technique should be used: Ethylene Oxide? X-Ray? Another technique?
  • Examining how the 3D printed material impacts the sterilisation technique chosen
  • Success stories and case examples
  • Outlining the specific challenges encountered with 3D printed products and how these are overcome
14:00 - 14:35 35 mins
Info
Drug Device Combination Products
Understanding the challenges associated with packaging and labelling for drug device combination products
  • Judit Jávor - Regulatory Affairs Expert & Compliance Director, PharmaPatent, Hungary
  • An overview of the labelling requirements for medical devices and pharmaceuticals in the context of combination products
  • Considering the usability requirements needed in packaging and labelling for a user-centric approach
  • Exploring the requirements when packaging single-integral and co-packaged combination products
  • How to navigate combination product-specific challenges such as drugs leaching into the primary packaging
14:00 - 14:35 35 mins
Info
IVD Regulatory and Strategic Forum
How the IVDR impacts both pharmaceutical and diagnostics manufacturers
  • Claudia Dollins - Head of Global Regulatory Affairs, Biomarkers & Diagnostics, Merck, Germany
  • Exploring increased requirements of companion diagnostics
  • Understanding the impacts of the IVDR on the companion diagnostics industry
  • Discussing the best practises to ensure effective partnerships
14:00 - 14:35 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Exploring the latest regulatory requirements across Latin America
  • Ana Luisa Fritschy - Manager Regulatory Affairs, Aptar Stelmi, France
  • What are the key features of medical device regulations in Argentina and Colombia?
  • What is changing in the regulations in these countries and what impacts will these changes have?
  • What similarities and differences exist between regulations across Latin America?
  • What are the methods for successful implementation in Latin America?
14:35 - 15:10 35 mins
Info
Sterilisation and Reprocessing of Medical Devices
Case study: Best practice sterilisation processes for drug device combination products
  • Jeff Vest - Principal Specialist – MHS (Technical Reviewer), TÜV SÜD Product Service, UK
  • Understanding the unique sterilisation challenges for combination products
  • Determining how the medical device and drug components create sterilisation challenges
  • Discussing what documentation the Competent Authorities will request for sterilisation
  • Highlighting why Ethylene Oxide is the main technique of choice for complicated combination products
14:35 - 15:10 35 mins
Info
Drug Device Combination Products
Case study: Best practice sterilisation processes for drug device combination products
  • Jeff Vest - Principal Specialist – MHS (Technical Reviewer), TÜV SÜD Product Service, UK
  • Understanding the unique sterilisation challenges for combination products
  • Determining how the medical device and drug components create sterilisation challenges
  • Discussing what documentation the Competent Authorities will request for sterilisation
  • Highlighting why Ethylene Oxide is the main technique of choice for complicated combination products
14:35 - 15:10 35 mins
Info
IVD Regulatory and Strategic Forum
Discussion of the implications of Brexit on the IVD industry
  • Fabien Roy - Counsel, Hogan Lovell, Belgium
  • Exploring the effects Brexit may have on the IVD industry in the UK and across Europe
  • Discussing how the regulations on IVDs are likely to change in the UK
  • Highlighting potential challenges UK IVD companies and the companies they work with may face in the coming years
14:35 - 15:10 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
A practical overview of Saudi Arabia’s pre-market process
  • Naif Alhussinan - Acting Section Head for Licensing Importers and Distributors, SFDA, Saudi Arabia
  • Clarifying the new changes in Saudi Arabia regarding the Medical Device Marketing Authorisation (MDMA) system and to the Medical Devices National Registry (MDNR)
  • Updates on the progress of the medical device bill
  • Discussing the impact changing regulations will have in Saudi Arabia and other Gulf states
15:10 - 15:40 30 mins
Afternoon tea and networking break
15:40 - 16:15 35 mins
Info
Sterilisation and Reprocessing of Medical Devices
Interactive Q&A Session: Sterilisation of drug device combination products
  • Tim Carlson - Sterilization Program Manager, Global Sterilization Assurance, BD, USA

This interactive Q&A Session will provide extended time for questions on the unique challenges faced in the sterilisation of combination products.

15:40 - 16:15 35 mins
Info
Drug Device Combination Products
Interactive Q&A Session: Sterilisation of drug device combination products
  • Tim Carlson - Sterilization Program Manager, Global Sterilization Assurance, BD, USA

This interactive Q&A Session will provide extended time for questions on the unique challenges faced in the sterilisation of combination products.

15:40 - 16:15 35 mins
IVD Regulatory and Strategic Forum
Open floor Q&A session
15:40 - 16:15 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
PANEL DISCUSSION: Navigating requirements and strategies for registering medical devices in the Middle East and North Africa (MENA)
  • Naif Alhussinan - Acting Section Head for Licensing Importers and Distributors, SFDA, Saudi Arabia
  • Mamoona Firdous - Regulatory Affairs Manager, Julphar, UAE
  • What are the best strategies for successfully registering medical device products in MENA countries?
  • What similarities and differences exist between key markets in the region?
  • What are the big challenges for industry and how can these be overcome?
16:15 - 16:20 5 mins
End of conference day five