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Jun 13
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09:00 - 09:10

Opening remarks from the Chairperson

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Showing of Streams
10:55 - 11:30

Morning coffee and networking break

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Showing of Streams
Showing of Streams
15:10 - 15:50

Afternoon tea and networking break

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Showing of Streams
17:35 - 17:40
End of conference day three

End of conference day three

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09:00 - 09:10 10 mins
Opening remarks from the Chairperson
09:10 - 09:45 35 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Notified Body perspective: MEDDEV 2.7.1 Revision 4 expectations and observations from industry on clinical evaluations
  • Itoro Udofia - Head of Notified Body, UL International (UK) Ltd., UK
  • Exploring an overview of the MEDDEV guidance document 2.7.1 rev 4 and key implications for industry
  • Reviewing what has been observed so far from assessment of technical files
  • Best practice for performing gap assessments and reviewing the need for additional resources
  • Discussing where industry are struggling with MEDDEV 2.7.1 rev 4 compliance
09:10 - 09:45 35 mins
Info
Post Market Surveillance and Vigilance
Case study: Ensuring best practice for Field Safety Corrective Action (FSCA) reporting
  • Maite Llácer - Director Quality Compliance INT’L, Edwards Lifesciences, Spain
  • Outlining how the new MDR impacts FSCA reporting and implications for industry
  • Understanding and meeting Competent Authority requirements for FSCA reporting
  • Clarifying what Competent Authorities require when initiating a recall
  • Exploring best strategies for getting FSCA responses from subsidiaries
09:10 - 09:45 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Clarification and exploration of the expectations of the CFDA for medical device registration
  • Jack Wong - Director, Asia Regulatory Professional Organisation, Singapore
  • Key points to consider when registering with the CFDA
  • Illuminating the format of the registration process
  • Discussing recent updates to the regulations
09:45 - 10:20 35 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Case study: Practically applying the new MEDDEV 2.7.1 rev 4 guidance for clinical evaluations
  • Avanti Kulkarni - Global Regulatory Affairs – Principal Clinical Evaluation Manager, Abbott Vascular, USA
  • David Rutledge - Director Global Regulatory Affairs, Abbott Vascular, USA
  • Exploring how the MEDDEV 2.7.1 rev 4 has been interpreted and applied to daily work
  • Discussing new requirements and how these have been addressed
  • Sharing experiences with implementing gap assessments
  • Overcoming key challenges and pitfalls when applying the new MEDDEV guidance
09:45 - 10:20 35 mins
Info
Post Market Surveillance and Vigilance
Case study: Successfully implementing a robust complaint handling and surveillance system
  • Anne Mørkeberg Larsen - Senior Product Surveillance Advisor, Novo Nordisk A/S, Denmark
  • Dan Sonne Pedersen - Product Defects and Recall Advisor, Novo Nordisk, Denmark
  • Best approaches for complaint handling and surveillance for high volume end-user products
  • How to keep complaint handling and surveillance in focus
  • Integrating Quality Risk Management with complaint management
  • Case study – how an increased trend initiated a FSCA for an insulin injector
09:45 - 10:20 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Case study: Navigating China’s regulatory processes for successful product registration
  • Wen Peng - Director of APAC Regulatory Affairs, Edwards Lifesciences, China
  • Sharing practical experience including preregistration, clinical trials, and PMS.
  • Practical advice on what is critical when designing implementation strategies
  • Discussion of the common nonconformities in the process
10:20 - 10:55 35 mins
Info
Clinical Evaluations and Investigations for Medical Devices
The medical writing agency's role in optimising the efficiency of CER preparation
  • Beata Wilkinson - Medical Director – CERs, Cactus Communications, UK
  • Possessing many competencies required of evaluators under MEDDEV 2.7/1 Rev 4
  • Committed to maintaining regulatory knowledge and professional skills up-to-date
  • Well placed to assume a coordinating role within the clinical evaluation team
  • Experienced in managing inputs from several specialists and data sources
10:20 - 10:55 35 mins
Info
Post Market Surveillance and Vigilance
How to integrate Complaint Trending with Risk Management
  • Ruben Roijers - Post Market Surveillance, Philips, The Netherlands
  • How to set-up Risk Management
  • How to link Risk Management to Complaint Handling
  • How to do trending of the generated data within Post-Market Surveillance
10:20 - 10:50 30 mins
Medical Device Regulatory Affairs in Emerging Markets
Please move to another stream
10:55 - 11:30 35 mins
Morning coffee and networking break
11:30 - 12:05 35 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Case study: Practically preparing for stricter clinical evidence requirements for legacy products under the new MDR
  • Leo Hovestadt - International Regulatory Affairs and Quality Assurance Director, Elekta, The Netherlands
  • Discussing the level of clinical evidence required for legacy products and whether new clinical data is required
  • Reviewing practical steps to be taken to prepare for stricter requirements
  • Outlining Notified Body and Competent Authority expectations
  • Examining key concerns and challenges
11:30 - 12:05 35 mins
Info
Post Market Surveillance and Vigilance
Outlining new timelines for post market reporting and practically meeting requirements
  • Tabitha Reed - Senior Manager, Regulatory Post Market Surveillance, Intuitive Surgical, Inc., USA
  • Reviewing new timelines for post market reporting from 30 days to 15 days
  • Examining regulatory requirements for post market reporting and best practice for meeting these
  • Outlining how new timelines for reporting could be a challenge for industry
11:30 - 12:05 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
INTERACTIVE ROUND TABLE SESSION: Sharing experiences with successfully registering products in China
  • Jack Wong - Director, Asia Regulatory Professional Organisation, Singapore
  • Bernd Schell - Senior Manager RA EMEA CCEM, Baxter, Germany
  • Maduagwu Oji - Senior Manager RA EMEA CCEM, Baxter, UK
  • What experiences and strategies have successful?
  • How can CFDA approval times be sped up?
  • What challenges have been encountered and how can they be overcome?
12:05 - 12:50 45 mins
Info
Clinical Evaluations and Investigations for Medical Devices
State of the art best practices and literature review using DistillerSR
  • Laurie Mitchell, Criterion Edge Inc., USA
  • Peter O’Blenis - President, Evidence Partners, Canada

Identifying and defining the clinical background/state of the art for a medical device is a critical component of a MEDDEV 2.1/7 revision 4 compliant Clinical Evaluation Report (CER). The state of the art, describing what is currently and generally considered good practice for the indications or intended use of a device, provides the context that is critical for the assessment of the safety and performance of the device and its benefit/risk acceptability. With clarification of the state of the art in revision 4, regulatory bodies are increasing their scrutiny on this CER component. This presentation will focus on:

  • Understanding the MEDDEV 2.1/7 revision 4 meaning of “state of the art”
  • Establishing sound methods to identify and select pertinent literature
  • Analyzing and presenting the state of the art comprehensively yet concisely
  • Consistently and efficiently producing and maintaining a fully compliant and audit ready clinical background/state of the art description using DistillerSR
12:05 - 12:40 35 mins
Info
Post Market Surveillance and Vigilance
High-Quality Real-World Clinical Big Data Helps Fast and Cost-efficient Clinical Studies and Regulatory Authorization
  • Vivian Tian - Overseas Business Development Manager, 1MData (Beijing Yiming Technology Co.,Ltd), China
  • A fast and Cost-Efficient Solution for pre-/post-marketing clinical studies.
  • High-quality real-world clinical big data with statistical analysis.
  • Patented technology with natural language processing and rules engine. Secured data storage and transfer.
12:05 - 12:40 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Software as a Medical Device (SaMD) and Cybersecurity in China
  • Tobias Schreiegg - Quality & Regulatory Affairs Manager, Siemens Healthcare, Germany
  • Examining the CFDAs SaMD regulations and the new classification changes
  • Guidance on following the clinical evaluation requirements for software
  • Exploring the new submission guidance on cybersecurity
12:40 - 14:00 80 mins
Post Market Surveillance and Vigilance
Networking lunch
12:40 - 14:00 80 mins
Medical Device Regulatory Affairs in Emerging Markets
Networking lunch
12:50 - 14:00 70 mins
Clinical Evaluations and Investigations for Medical Devices
Networking lunch
14:00 - 14:35 35 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Case study: Practically applying risk based monitoring for medical device clinical investigations
  • Nurcan Coskun - Global Risk Based Monitoring & Technology Solutions Program Manager, Medtronic, Switzerland
  • Outlining the current approach to risk based monitoring
  • Ensuring all relevant files are updated successfully
  • Setting up a successful project group
  • Overcoming key challenges and pitfalls
14:00 - 15:10 70 mins
Info
Post Market Surveillance and Vigilance
INTERACTIVE SESSION: How can I be compliant with the MDR Post Market activities and reports?
  • Philippe Auclair - Senior Director, Regulatory Strategy & Advocacy, Abbott Quality & Regulatory, Abbott, Belgium
  • Laure-Anne Thieren - Manager Business Process, Quality & Compliance, Johnson & Johnson Medical Devices, Belgium

The MDR and IVDR are changing fundamentally the approach to Post Market, introducing a continuous risk assessment based during the entire product life time.

The session will review these changes and via an interactive session will attempt to define the changes required for compliance.

The following area will be discussed:

  • Clinical evidence and the device lifecycle
  • PMS system
  • PMS plan
  • PMSR/ PSUR
  • Complaints and vigilance
  • Electronic submission
14:00 - 14:35 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
The implementation progress of the ASEAN Medical Device Directive (AMDD)
  • Jack Wong - Director, Asia Regulatory Professional Organisation, Singapore
  • Updates on the current progress and differences throughout the region
  • Country highlights: Singapore, Thailand, Malaysia
  • Discussing future requirements for medical devices in the ASEAN countries
14:35 - 15:10 35 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Case study: Implementing a successful clinical investigation / post market clinical follow up (PMCF) strategy
  • Dorota Johansson - Clinical and Research Director, Bactiguard, Sweden
  • Determining for which devices a clinical investigation prior CE mark is needed
  • Discussing whether the MDR addresses a more harmonised regime for clinical investigations across Member States
  • Best practice for preparing and performing a robust clinical study following ISO 13485
  • Assessing how best document and appraise the clinical study data according to MEDDEV 2.7.1 revision 4
  • Build a portfolio of clinical and PMCF studies as a competitive assessment of your Medical Device
14:35 - 15:10 35 mins
Medical Device Regulatory Affairs in Emerging Markets
Who should be the In-country Representative/Product license holder & Challenges in medical device registration in ASEAN countries
  • May Ng - Global Regulatory & Quality Consultant, Director, ARQon, Singapore
15:10 - 15:50 40 mins
Afternoon tea and networking break
15:50 - 16:25 35 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Case study: Successfully outsourcing clinical investigations
  • Frank Van Leeuwen, Focus Clinical Consultancy, Belgium
  • Establishing what needs to be outsourced: Full service vs. specific activities
  • Understanding how to choose the right CRO with the most relevant experience for your investigation
  • Best strategies for assuring quality when outsourcing and what kind of oversight is needed
  • Examining advantages and disadvantages of outsourcing
15:50 - 16:25 35 mins
Info
Post Market Surveillance and Vigilance
Generating the necessary evidence through Life Cycle Communication strategy
  • Patrice Becker - Global Director Scientific Communications, Medical Affairs, Medtronic, France
  • Understanding how to generate the necessary evidence
  • Use of the Life Cycle Communication strategy
15:50 - 16:25 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
PANEL DISCUSSION: Sharing experiences with medical device registration in ASEAN countries
  • May Ng - Global Regulatory & Quality Consultant, Director, ARQon, Singapore
  • Jack Wong - Director, Asia Regulatory Professional Organisation, Singapore
  • What makes a successful implementation strategy for ASEAN medical device registration?
  • What challenges does the dynamic AMDD implementation bring?
  • How to select and work with local distributors?
16:25 - 17:00 35 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Reviewing requirements of the new MDR for demonstrating equivalence for clinical evaluations
  • Regina Moeckel - Medical Devices, TÜV Rheinland LGA Products GmbH, Germany
  • Clarifying the requirements for demonstrating equivalence
  • Understanding how to demonstrate equivalence in an effective way to satisfy Notified Body requirements
  • Assessing what parameters are used for demonstrating equivalence
  • Best practice for demonstrating equivalence for new devices – how this can be achieved and reported to Notified Bodies
  • Examining key challenges experienced when demonstrating equivalence
16:25 - 17:00 35 mins
Info
Post Market Surveillance and Vigilance
Case study: Best strategies for leveraging post market surveillance (PMS) data to become better informed about your products
  • Patrick Caines - Senior Director, Quality & Compliance, Baxter, USA
  • Exploring which kind of data was collected and where it was collected from
  • Determining what should be done with the data to make it more relevant and valuable
  • Discussing whether a medical device company can learn anything from a pharmaceutical company with respect to data
16:25 - 17:00 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
The impact of the EU Medical Device Regulation (MDR) on emerging markets
  • Elena Mateo-Buesa - Regulatory Affairs Manager, Global Strategy, Ethicon, Germany
  • Investigating the impact the new MDR might have on emerging markets with regulations based on the EU Medical Device Directive
  • Examining whether these markets are likely to update their regulation to match the MDR 
  • Assessing the impacts there may be in respect to new quality management system certificates, labelling, and post-market surveillance
17:00 - 17:35 35 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Outlining requirements for clinical evidence for class III devices in the MDR
  • Eddie Van Eeckhoven - Medical Device Regulatory and Clinical Advisor, Eeckhoven bvba, Belgium
  • Exploring clinical evidence requirements for class III medical devices under the MDR
  • Analysing what further updates must be done to upgrade from MEDDEV 2.7.1 rev 4 to the MDR clinical evaluation
  • Determining what kind of studies should be carried out for class III devices
  • Discussing key challenges and concerns
17:00 - 17:35 35 mins
Post Market Surveillance and Vigilance
End of day - please feel free to move to one of the parallel tracks
17:00 - 17:35 35 mins
Medical Device Regulatory Affairs in Emerging Markets
End of day - please feel free to move to one of the parallel tracks
17:35 - 17:40 5 mins
End of conference day three