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Jun 19
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08:00 - 09:00

Registration

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Showing of Streams
10:40 - 11:30

Morning coffee and networking break

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Showing of Streams
12:30 - 13:50

Networking lunch

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Showing of Streams
14:50 - 15:20

Afternoon tea and networking break

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Showing of Streams
16:50 - 16:55
End of conference day three

End of conference day three

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08:00 - 09:00 60 mins
Registration
09:00 - 09:10 10 mins
Clinical Evaluations and Investigations for Medical Devices
Opening remarks from the Chairperson
09:00 - 09:10 10 mins
Post Market Surveillance and Vigilance
Opening remarks from the Chairperson
09:00 - 09:10 10 mins
Medical Device Regulatory Affairs in Emerging Markets
Chairman’s Opening Remarks
09:00 - 10:40 100 mins
Info
TRAINING COURSE: Medical Device Regulatory Project Management
Introduction to Project Management
  • Heikki Pitkänen - CEO & Founder, Digital Regulatory Runways, Lean Entries
  • Early development stages in a project:
    • Capturing the value proposition
    • Clinical and benefit-risk considerations
    • Early validation through feasibility studies
    • Regulatory strategy


  • Planning and initiating the project
    • Timelines, responsibilities and team communication
    • Document and records management
09:10 - 09:40 30 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Assessing the increased requirements for Clinical Evaluation Reports (CERs) under the MDR
  • Basira Salehi - Senior Manager Clinical Science & Medical Affairs, Biotronik
  • Clarifying what information needs to be included in the CER
  • Understanding the quality of content needed to submit a sufficient CER to the authorities
  • Defining equivalency and clarifying what needs to be demonstrated
  • Examining how GCP guidelines have been incorporated into the MDR and how this impacts CERs
  • Comparing CER requirements for legacy and new products: what’s changed and what’s stayed the same?
09:10 - 09:40 30 mins
Info
Post Market Surveillance and Vigilance
Post market surveillance and the risk management process
  • Radim Smitka - Manager Regulatory Affairs, Complaints & Vigilance, Straub Medical
  • Sources for PMS
  • Understanding how PMS data contributes to a more efficient risk management process
  • How to efficiently incorporate the complaint and vigilance data into risk management?
  • How to link PMS to RM
  • The most typical deficiencies of the manufacturers
09:10 - 09:40 30 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Regulatory Overhaul: Updates on the Medical Device Regulation in China
  • Jack Wong - Head of Regulatory Affairs APAC, Baxter & Founder, Asia Regulatory Professional Association
  • Discussing the rationale behind the recent CFDA/NMPA restructuring
  • A review of the newly published amendments to the Chinese Medical Device Regulations and its impact on industry
  • Assessing the associated challenges and opportunities for market entry into China
09:40 - 10:10 30 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Case study: Performing clinical evaluations in context of the new MDR
  • Alexandros Charitou - Life Sciences Consultant / Clinical, Regulatory, Quality & Safety, Navigant
  • Practical advice on how clinical evaluations should be completed
  • Assessing the key issues and understanding how to address them
09:40 - 10:10 30 mins
Info
Post Market Surveillance and Vigilance
Successfully bringing together Risk Management, Clinical Evaluation and Post Market Surveillance Plans to streamline ways of working
  • Berlind Kalve - Corporate Expert Postmarket Compliance, Otto Bock Healthcare Products GmbH, Austria
  • Risk Management, Clinical Evaluation and PMS under the MDR
  • Understanding how RM, CE and PMS Plans are aligned and correlated in different companies
  • Assessing how the data are collected and analysed - managing stakeholders, sites and countries - examining the best way to consolidate available information
  • Assessing some of the common pitfalls and advice for overcoming them
09:40 - 10:10 30 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Case Study: Best Practice for Successful Product Registrations in China
  • Ed Woo - AP Regulatory Affairs Director, Varian Medical, Hong Kong
  • Tackling the expectations of the NMPA during registration
  • Developing a comprehensive strategy for product approval in China
  • Practical advice for overcoming regulatory hurdles and nonconformities
10:10 - 10:40 30 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Clinical evaluations: comparing IMDRF vs MDR items and assessing what this means in practice for manufacturers
  • Leo Hovestadt - International Regulatory Affairs and Quality Assurance Director, Elekta, The Netherlands
  • Comparable (IMDRF) versus the two types of EU Equivalence (MDR)
  • Clinical Evaluation: IMDRF vs MDR
  • Clinical Evidence / Data, including “overseas” clinical investigation: IMDRF vs MDR
10:10 - 10:40 30 mins
Info
Post Market Surveillance and Vigilance
High-Quality Real-World Clinical Big Data to Support Post-Market Clinical Follow- ups/Studies of Medical Devices
  • Vivian Tian - Overseas Business Development Manager, 1MData (Beijing Yiming Technology Co.,Ltd), China
  • Jing Du - Manager, Biostatistics, Abbott, US
  • High-Quality Real-World Clinical Big Data on clinical performance and safety of medical devices
  • Thorough in-hospital data with years of clinical-follow ups available
  • Competitor data on clinical performance and safety
  • Projects experiences for EU MDR PMCF reports and FDA PMS with top MNC players
  • Post Market Clinical Follow up Reports have been accepted by EU Notified Bodies
10:10 - 10:40 30 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Guidance on Chinese Clinical Conformity Evaluations for Device Approval
  • Heinrich Martens - Director Regulatory Affairs & QA, Fresenius Kabi
  • Review of the NMPA requirements for device testing and clinical evaluation
  • Determining the appropriate route to clinical conformity (including CERs, clinical trial data, GCP)
  • Best practice for conducting clinical trials for medical device registration in China
10:40 - 11:30 50 mins
Morning coffee and networking break
11:30 - 12:00 30 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Practical Experience in conducting Clinical Evaluation Reports for Medical Devices
  • Sandra Bugler - Managing Consultant for Clinical Affairs, PROSYSTEM
  • Structuring a template for the plan and report
  • Explaining the most important success factors for conducting clinical evaluations
  • Sharing lessons learned and “what to avoid”
  • Assessing difficulties when clinical evaluations get started
11:30 - 12:00 30 mins
Info
Post Market Surveillance and Vigilance
Post market surveillance and standards: Strategies for maintaining State of the Art
  • Hendrik Heinze - Quality & Regulatory Affairs Director, Berlin Heart GmbH
  • Understanding the extent to which standards are harmonised to the MDR
  • Examining what Notified Bodies are looking for from industry to demonstrate compliance
  • Defining State of the Art
  • Strategies to ensure and demonstrate compliance with the latest version of the standard
  • Defining post market testing plans prior to product launch
  • Putting in place testing plans to make sure the data is collected
11:30 - 12:00 30 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Understanding the Medical Device Regulatory Landscape in Pakistan and India
  • Maham Ansari - Director of Regulatory Affairs, Synaptive Medical, Canada
  • An overview of the Pakistani and Indian regulatory framework and requirements for product registration
  • Explore the differences between regulatory approval systems and assessing the impact of the new regulations on industry
  • Discuss nuances in the in vitro diagnostic regulatory pathway
  • Cover any specific QMS requirements
11:30 - 12:30 60 mins
Info
TRAINING COURSE: Medical Device Regulatory Project Management
Applying Regulatory Requirements to Project Management
  • Heikki Pitkänen - CEO & Founder, Digital Regulatory Runways, Lean Entries
  • The role of global regulations and standards in medical device project management
  • Key regulatory considerations throughout the medical device lifecycle:
    • General Safety and Performance Requirements
    • Clinical Evaluation
    • Risk Management


  • Other regulatory considerations for project management:
    • Quality system requirements (ISO 13485, FDA QSR)
    • Design Control
    • Vendor control
12:00 - 12:30 30 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Industry case study: Practically gathering and using clinical evidence for legacy products
  • Benjamin Rochette - Senior Regulatory Affairs Specialist, Medtronic
  • The pivotal role of Scientific Societies and clinical investigators under the MDR era
  • The value of real world clinical evidence for post-market surveillance and regulatory decision-making
  • Common pitfalls and opportunities
12:00 - 12:30 30 mins
Info
Post Market Surveillance and Vigilance
Spotlight Session: Examining available content management tools for PMS data

If you are interested in speaking in this session, please contact Linda Cole Tel +44 (0) 20 7017 6631; email linda.cole@knect365.com

12:00 - 12:30 30 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Developing a Labelling Strategy for APAC Device Registrations
  • Kelvin Koh - Director APAC Regulatory Affairs, Terumo BCT
  • Sharing practical experience of label preparation in the APAC region
  • Discussing the regulatory challenges of multi-country labelling strategies
  • Best practice for designing a successful regulatory strategy to speed time to market
12:30 - 13:50 80 mins
Networking lunch
13:50 - 14:20 30 mins
Info
Clinical Evaluations and Investigations for Medical Devices
MDR requirements on clinical investigations compared to the current legislation (MDD/AIMDD) and ISO 14155
  • Klaus Schichl - Director Clinical Affairs CRM/EP, BIOTRONIK
  • Definitions
  • Planning and design of a clinical investigation
  • Application or notification to the competent authority
  • Conduct of the clinical investigation
  • Documentation and Reporting
13:50 - 14:20 30 mins
Info
Post Market Surveillance and Vigilance
An update on the templates that are being developed for Periodic Summary Update Reports (PSURs)
  • Paola Borgnolo - Regulatory and Compliance Specialist, Biomerieux
  • Understanding why PSURs have been updated and examining the extent to which they are becoming more like medicinal product reports
  • What will the new PSUR templates look like?
  • Establishing who the owner of the document should be and what needs to be included on the form       
13:50 - 14:20 30 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Regulatory Requirements for Accessing the South Korean Market
  • Mei Ru Li - Global Regulatory Affairs Consultant, Knoell Germany GmbH, Germany
  • Main regulatory changes in South Korea regulation
  • Changes in the KGMP within South Korea regulation
  • Understanding MFDS on-site inspections of foreign facilities
  • Practical APAC RA/QA insights on Northern Asia regulatory changes for China and Taiwan
13:50 - 14:50 60 mins
Info
TRAINING COURSE: Medical Device Regulatory Project Management
Applying Clinical Evaluation in a Project
  • Heikki Pitkänen - CEO & Founder, Digital Regulatory Runways, Lean Entries
  • The importance of conducting a literature review
  • Clinical investigations and post-market activities
14:20 - 14:50 30 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Legacy products under the MDR - using equivalence?
  • Alexandra Rieben - Global Lead Clinical Research & University Account Management, NOBEL BIOCARE SERVICES AG
  • Examining the definition of “sufficient clinical data”
  • Performing gap analysis and setting up a roadmap
  • Understanding and using equivalence
  • Assessing money and time required to successfully collect data on legacy products
  • Advice for industry working with legacy products
14:20 - 14:50 30 mins
Info
Post Market Surveillance and Vigilance
Serious incident reporting: clarifying the new requirements under the MDR and the practical implications for manufacturers
  • Angeles Sanfrancisco - Manager, Quality Compliance, Transcatheter Heart Valves, Edwards Lifesciences SL
  • MDD vs MDR - Impact on vigilance reporting requirements
  • Ensure systems and processes are up to scratch to ensure compliance
14:20 - 14:50 30 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
ASEAN Medical Device Directive (AMDD) Implementation Status Update
  • Sasikala Devi Thangavelu - Director of Policy, Code & Standard Division, Medical Device Authority Malaysia, Malaysia
  • Discussing the harmonisation efforts in the region and upcoming timelines
  • Updates on the current adoption and implementation progress of ASEAN MDD
  • Guidance on how best to prepare for the for the 2020 deadline
  • Q&A
14:50 - 15:20 30 mins
Afternoon tea and networking break
15:20 - 15:50 30 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Running a clinical investigation: Examining the pitfalls and opportunities
  • E. Lynne Kelley, MD, FACS - Chief Medical Officer, Histogenics
  • Defining the goals of the investigation
  • Best practice for complying with ISO 13485
  • Evaluating and deciding in which country to conduct the clinical investigation
  • Examining which factors should be considered when recruiting clinicians and investigators
  • Understanding how best to document your clinical study
15:20 - 15:50 30 mins
Info
Post Market Surveillance and Vigilance
Economic Operator responsibilities and PMS and vigilance
  • Markus Pöttker - MDR Post Market Surveillance Lead, Safety & Surveillance, Smith & Nephew
  • How have the new responsibilities placed upon economic operators impacted PMS and vigilance activities and processes?
  • Mapping out economic operator responsibilities to ensure PMS and vigilance requirements are adhered to
  • How are companies implementing the changes?
  • Examining key challenges faced by industry


15:20 - 15:50 30 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Interactive Discussion: Sharing Experiences of Successfully Registering Devices in ASEAN Countries
  • Chairing: May Ng - Global Regulatory & Quality Consultant, Director, ARQon, Singapore
  • Maham Ansari - Director of Regulatory Affairs, Synaptive Medical, Canada
  • Johanna Wright - Regulatory Affairs Director, ResMed
  • Feedback and advice for designing a successful regulatory strategy for ASEAN medical device registration
  • Sharing experiences of registration hurdles and how to overcome them
  • Filling in the blanks: discussing regional requirements for classification, licensing, labelling and post-market surveillance issues
15:20 - 16:05 45 mins
Info
TRAINING COURSE: Medical Device Regulatory Project Management
Applying Risk Management in a Project
  • Heikki Pitkänen - CEO & Founder, Digital Regulatory Runways, Lean Entries
  • Risk management practicalities
    • ISO 14971 and Design FMEA (Failure Modes & Effects Analysis)
    • Relation to Biocompatibility, Electrical safety, Software life cycle and Usability


  • Benefit-risk analysis as the final outcome
15:50 - 16:20 30 mins
Info
Clinical Evaluations and Investigations for Medical Devices
Assessing the impact of the General Data Protection Regulation on clinical investigations
  • An Vijverman - Partner, Dewallens & Partners LLP, Belgium
  • Evaluating the balance between data privacy and transparency
  • Distinguishing pseudonymisation and anonymisation terms in trial protocols
  • Advice for industry to ensure compliance with MDR and GDPR
15:50 - 16:20 30 mins
Info
Post Market Surveillance and Vigilance
Risk management and trend reporting
  • Rikke Lewinsky - Principal Specialist, Complaint Surveillance, Novo Nordisk

• Providing an update on the new trend reporting requirements

• How your risk management improve surveillance and trend reporting

• Be efficient when processing information for trending; surveillance setup for high volume end-user products

• Strategies for incorporating risk management in single incidents

15:50 - 16:20 30 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Feedback on the Malaysian Medical Device Registration Process
  • Sasikala Devi Thangavelu - Director of Policy, Code & Standard Division, Medical Device Authority Malaysia, Malaysia
  • An update on the latest Malaysian regulatory requirements for medical devices
  • Feedback on best practices, challenges and how to overcome them
  • Discussing the policies and implementation timelines for fast track registrations in Malaysia
16:05 - 16:50 45 mins
Info
TRAINING COURSE: Medical Device Regulatory Project Management
Managing Medical Device Project Cycles
  • Heikki Pitkänen - CEO & Founder, Digital Regulatory Runways, Lean Entries
  • Product life cycle thinking: Does the project have an end?
  • Design Control as the middle cycle: The typical project cycle
    • Design Inputs, Outputs, Verification, Validation, Process Validation, Transfer, Changes and Reviews


  • The micro cycles of project management: The daily work
    • Plan-Do-Check-Act / Build-Validate-Learn / Agile methodologies


  • Maintaining alignment and adapting to change
    • Corrective and preventive actions and methods
    • Project metrics
16:20 - 16:50 30 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Reviewing the Australian Registration and Approval Processes for Medical Device
  • Johanna Wright - Regulatory Affairs Director, ResMed
  • Understanding the Australian regulatory landscape and TGA expectations for submissions
  • Discussing challenges and strategies for overcoming them
  • Experiences and practical guidance for the use of expedited pathways
16:50 - 16:55 5 mins
End of conference day three