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Jun 20
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08:30 - 09:00

Registration

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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 networking refreshments

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Showing of Streams
16:50 - 17:00

End of conference day four

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08:30 - 09:00 30 mins
Registration
09:00 - 09:10 10 mins
IVD Regulation and Strategy
Opening Remarks from Chairperson
09:00 - 09:10 10 mins
Clinical Outsourcing for Medical Device Trials
Opening Remarks from Chairperson
09:00 - 09:10 10 mins
Medical Device Regulatory Affairs in Emerging Markets
Opening Remarks from Chairperson
09:00 - 09:10 10 mins
Drug Device Combination Products
Opening remarks from the Chairperson
09:00 - 10:55 115 mins
Info
TRAINING COURSE: US Regulatory Affairs for Medical Devices
Overview of FDA regulation
  • Sam Martin - Consultant in BioMedical Technology Regulatory and Clinical Affairs, Director, The Regulatory and Clinical Partnership Ltd.
  • Comparison with EU Regulation
  • Medical devices, drugs, and combination products
  • FDA Structure: Divisions and offices
  • FDA Center for Devices and Radiological Health (CDRH)
  • Code of Federal Regulations (CFR)
  • Regulatory requirements
    • Establishment registration
    • Medical device listing
    • Clearance, approval, exemptions
    • Investigational device exemptions for clinical investigations
    • Quality system regulation
    • Labelling
    • Medical device reporting


Sources of Information

  • FDA website / guidance / Standards / databases
09:10 - 09:45 35 mins
Info
IVD Regulation and Strategy
Managing the transition to IVDR – the road to 2022
  • Speaker Invited: (invited speaker) Stephen Lee - Biosciences Team Manager, MHRA
  • How are Competent Authorities interpreting the IVDR?
  • Exploring strategies Competent Authorities are employing to prepare for the IVDR
  • Understanding whether the transition period will be extended
  • Highlighting the changes in Competent Authority procedures following the IVDR
09:10 - 09:45 35 mins
Info
Clinical Outsourcing for Medical Device Trials
Notified Body perspective: Practical advice for industry on meeting new requirements for clinical operations and outsourcing under the MDR
  • Clarifying Notified Body interpretation of MDR clinical trial requirements
  • Understanding what Notified Bodies are looking for from manufacturers to obtain a CE Mark
  • Defining “sufficient clinical data”: what are the requirements and clinical expectations for new devices?
  • Examining the extent to which the MDR is aligned with ISO 14155
  • Key challenges and opportunities
09:10 - 09:45 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
ANVISA Feedback – Updates on the Regulatory Landscape and Requirements in Brazil
  • Augusto Geyer - Deputy General Manager, Medical Devices Office, ANVISA, Brazil
  • Discussing the current regulatory requirements for medical device registration and ANVISA plans for future
  • Examining the impact of the clinical trials regulation on industry
  • Practical guidance on registrations, common nonconformities and answering your questions
09:10 - 09:45 35 mins
Info
Drug Device Combination Products
An Overview of the Current Regulatory Landscape for Drug Device Combination Products
  • Ann Jans - Medical Devices Quality Assessor, FAMHP, Belgium
  • Competent Authority perspective on drug device combination products
  • Proposed actions to align regulation of both drug and device industry 
  • Practical advice to manufacturers on preparing for MDR
  • Discussing the recent challenges and Competent Authority expectations
09:45 - 10:20 35 mins
Info
IVD Regulation and Strategy
Practically preparing for the transition to the IVDR: large company perspective
  • Mirna DiPano - Regulatory Affairs Director, Abbott Diagnostics, US
  • Highlighting key differences between the previous and new regulations
  • Interpreting the guidance around common specifications and product groups
  • Undertaking a gap analysis to assess where resource should be dedicated
  • Understanding and planning for the new classification requirements
  • Implementation success: strategies for gaining senior management buy in and keeping the momentum going
09:45 - 10:20 35 mins
Info
Clinical Outsourcing for Medical Device Trials
Successfully selecting vendors with the most relevant experience for your clinical trials
  • E. Lynne Kelley, MD, FACS - Chief Medical Officer, Histogenics
  • Strategies for reviewing potential outsourcing partners
  • Examining the level of medical device expertise
  • Assessing vendor competency and knowledge of the regulatory requirements (MDR and ISO 14155) surrounding medical device trials
  • Selecting the right CRO to suit the specific trial needs and expectations
09:45 - 10:20 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Case Study: Implementing Brazilian Regulatory Requirements for High-Risk Devices
  • Industry perspective of the current regulatory framework for devices classified as high-risk
  • Guidance on implementing requirements such as UDI, clinical data and mechanical testing
  • A comparison of the Brazilian requirements to US and EU regulations: to what extent can harmonisation be achieved
09:45 - 10:20 35 mins
Info
Drug Device Combination Products
Notified Body Perspective on EU MDR and its Impact on Combination Products
  • Julia Frese - Department Manager Centre of Combination Products, , TÜV SÜD Product Service GmbH, Germany
  • Notified Body interpretations of Article 117 and expectations for manufacturers
  • Understanding the impact of additional Notified Body scrutiny during the conformity assessment
  • Outlining common pitfalls and how they can be avoided
10:20 - 10:55 35 mins
Info
IVD Regulation and Strategy
Practically preparing for the transition to the IVDR: small company perspective
  • Paul Kenny - Regulatory Affairs Head, Oxford Gene Technology
  • Know your enemy
  • Banging the drum
  • Eating the elephant
  • Culling the herd
  • Boiling the frog
10:20 - 10:55 35 mins
Info
Clinical Outsourcing for Medical Device Trials
Strategies for successful sponsor/vendor relationship management: SME perspective
  • Colin Irwin - Clinical Operations Manager, Cochlear AG
  • Different options for outsourcing a clinical investigation, or the execution activities to a CRO
  • Strategies for ensuring an early alignment of expectations between both sponsor and vendor
  • Assessing the CRO’s understanding of what’s involved: the study protocol, monitoring requirements, etc.
  • Ensuring effective communication and vendor oversight throughout the clinical investigation life cycle
  • Ensuring non-clinical goals of the clinical investigation are met: budgets, timelines and protocols
10:20 - 10:55 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Ensuring Compliance for INMETRO Medical Device Certification
  • Georg Bauer - Department Manager Regulatory Affairs, TÜV SÜD, Germany (subject to final confirmation)
  • Evaluating the current registration procedures required by INMETRO
  • Developing a successful QMS strategy to ensure GMP compliance during audits
  • Feedback for industry on submissions under the newest requirements and guidance on what INMETRO is looking for
10:20 - 10:55 35 mins
Drug Device Combination Products
Presentation to be delivered by 3D Communications
  • Susan Resnick - Scientific Lead, 3D Communications
10:55 - 11:25 30 mins
Morning coffee and networking break
11:25 - 12:00 35 mins
Info
IVD Regulation and Strategy
Notified Body feedback: Implementing the IVDR
  • Andreas Stange - Vice President MHS global IVD, TÜV SÜD
  • Understanding how Notified Bodies and planning and preparing for the 2022 deadline
  • Understanding how best manufacturers can utilise transition time to the IVDR
  • Defining the standards, clarifying the requirements and understanding what Notified Bodies are looking for from industry
11:25 - 12:00 35 mins
Info
Clinical Outsourcing for Medical Device Trials
CASE STUDY: Managing the situation when disputes occur between sponsor and vendor
  • Dr. Victoria J. Cavendish - Director, Orca Solutions Ltd.
  • Understanding where things might go wrong
  •  Best practice communication and relationship management between sponsor and   vendor
  •  Overcoming difficulties and differences throughout the trial process
  •  Examining lessons learned and how to improve future ways of working
11:25 - 12:00 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Dual Presentation: Updates and Practical Advice for Registrations Using the MDSAP
  • Bill Kurani - MSRA, MSEE, Head of RA/QA, Genomics, Agilent Technologies, USA
  • Mercedes Bayani - Global Director Clinical and Regulatory Affairs, Bioness
  • An update on the status of Brazil’s MDSAP program and future outlook for the medical device industry
  • Understanding the GMP audit system and determining the right course of action (MDSAP, ANVISA, INMETRO)
  • Sharing experiences and advice for successfully registering products through MDSAP
11:25 - 12:00 35 mins
Info
Drug Device Combination Products
Industry Case Study: Building a Successful Regulatory Strategy for Drug Device Combination Products
  • Discussing strategies for practical implementation of the EU MDR and Article 117 for drug device combination products
  • Addressing key conclusions and lessons learned since the release of the EU MDR
  • Guidance on working with Notified Bodies to achieve regulatory success
11:25 - 12:05 40 mins
Info
TRAINING COURSE: US Regulatory Affairs for Medical Devices
Routes to Market
  • Device classification

using Section 513(g)

  • Premarket notification – 510(k)
    • Traditional
    • Abbreviated
    • Special
    • de novo
    • exemptions


  • Predicates and Substantial equivalence
  • Premarket Approval – PMA
12:00 - 12:35 35 mins
Info
IVD Regulation and Strategy
Spotlight Session: Examining labelling and UDI requirements for IVDs

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 - 12:35 35 mins
Info
Clinical Outsourcing for Medical Device Trials
Clinical Outsourcing Spotlight Session

For information on speaking on the Clinical Outsourcing programme, please contact Linda Cole on: linda.cole@knect365.com or  +44 (0) 207 017 6631

12:00 - 12:35 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Designing an Effective Labelling Strategy for Product Registrations in LATAM
  • Gloria Schneider-Ferrer - Manager, Global Strategy - Brazil, DePuy Synthes, Switzerland
  • Examining the unique labelling requirements for the major markets in Latin America
  • Clarification on expectations of LATAM regulators and discussing the challenges
  • Success stories: how to comply with labelling regulations across the region
12:00 - 12:35 35 mins
Info
Drug Device Combination Products
Panel Session: Regulatory feedback, Plans and Practical Advice for Drug Device Combination Products
  • Panellist Kirsten Paulson - Senior Director, Global CMC-Medical Device Lead, Pfizer, US
  • Julia Frese - Department Manager Centre of Combination Products, , TÜV SÜD Product Service GmbH, Germany
  • Exploring current regulatory timelines
  • Discussing common pitfalls during the registration process and how they can be avoided
  • Outlining regulatory expectations, potential challenges and views on where the industry is heading
12:05 - 12:35 30 mins
Info
TRAINING COURSE: US Regulatory Affairs for Medical Devices
Verification and Validation
  • Preclinical safety testing
  • Clinical evaluation
    • Clinical data
    • Clinical evaluation reports
    • Post-market clinical follow-up
12:35 - 14:00 85 mins
Networking lunch
14:00 - 14:35 35 mins
Info
IVD Regulation and Strategy
Product classification: Understanding the new classification rules for IVDs on the market
  • Dieter Schoenwald, TÜV SÜD PRODUCT SERVICE GMBH
  • Assessing the difference between previous and new classification requirements
  • Examining the transition to 4 classes of IVD devices – understanding all products that are in the scope of the regulation
  • Undertaking a gap analysis and understanding how to manage the reclassification process and ensure the different stages are managed effectively
  • Managing the transition and working with the Notified Body
  • Borderline products: common technical specifications – transitioning across to the new common specifications
  • Risk benefit/GSPR/new products which don’t have a current CTS
14:00 - 14:35 35 mins
Info
Clinical Outsourcing for Medical Device Trials
Understanding and applying Risk Based Monitoring: Large company perspective
  • Nurcan Coskun, Ph.D - Global Risk Based Monitoring & Technology Solutions Program Manager, Medtronic, Switzerland
  • Strategies for practically implementing risk based monitoring
  • Exploring methods of risk identification
  • Examining centralized monitoring as a component to take mitigation and other actions
14:00 - 14:35 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Industry Experiences of Bringing Products to Market in Mexico
  • Industry perspective of the expectations and regulatory requirements during registration with COFEPRIS
  • Discussing challenges and strategies for overcoming them
  • Experiences and practical guidance for the use of expedited pathways
14:00 - 14:35 35 mins
Info
Drug Device Combination Products
Real life case study: Insulin drug device combination products – practical considerations for compliance and compatibility
  • Highlighting the common challenges of insulin combination products
  • Best practice for complying with both device and drug regulations when evaluating insulin combination products
  • Assessing drug/device compatibility and the impact on biocompatibility, stability, extractables & leachables, reactive leachables and proteins
14:00 - 15:10 70 mins
Info
TRAINING COURSE: US Regulatory Affairs for Medical Devices
Quality Management and Manufacturing
  • Quality standards and guidance
  • Manufacturing standards and guidance
  • Quality assurance and quality control

 

 

Labelling

  • Overview and guidance
  • Unique Device Identification (UDI)
  • UDI final rule and how it has been phased in
  • Labels and instructions for use
14:35 - 15:10 35 mins
Info
IVD Regulation and Strategy
Classification: Discussing the specific requirements for borderline products
  • Making the transition to the new common specifications and new requirements
  • Risk benefit and GSPR
  • Understanding which products will need a new common specification
14:35 - 15:10 35 mins
Info
Clinical Outsourcing for Medical Device Trials
Examining the key opportunities of Investigator Initiated Trials
  • Ruud Nonnekens - Project Manager Investigator Initiated Research, Philips- Image Guided Therapy Device International
  • Understanding the current landscape of Investigator Initiated Trials
  • Examining the recent increase in conducting IIT’s for medical devices
  • Exploring the win-win opportunities for site and sponsor including cost savings
14:35 - 15:10 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
LATAM Pain Points Panel Session
  • Gloria Schneider-Ferrer - Manager, Global Strategy - Brazil, DePuy Synthes, Switzerland
  • Sharing best practices and success stories of registrations across the region
  • Discussing common registration challenges and nonconformities
  • Practical advice for building a LATAM regulatory strategy
  • Q&A 
14:35 - 15:10 35 mins
Info
Drug Device Combination Products
Panel Session: Global Requirements for Combination Products
  • Examining combination product classifications and regulations in key global markets
  • Sharing experiences with DDCP registration for products around the world
  • Common challenges associated with innovative combination product registration in emerging markets


15:10 - 15:40 30 mins
Afternoon networking refreshments
15:40 - 16:40 60 mins
Info
IVD Regulation and Strategy
Notified Body interactive discussion: Designation, resource and capacity
  • Sue Spencer - Head of Global Medical Device Services, UL, UK
  • Dieter Schoenwald, TÜV SÜD PRODUCT SERVICE GMBH
  • Nick Baker - Head of IVD Notified Body, LRQA, UK
  • Andreas Stange - Vice President MHS global IVD, TÜV SÜD
  • Understanding the timeline for Notified Body designation
  • Capacity and resource: Understanding which Notified Bodies support IVDs
  • How can industry prepare for Notified Body audits?
  • Advice for industry
15:40 - 16:15 35 mins
Info
Clinical Outsourcing for Medical Device Trials
Revision of the ISO 14155: Clinical investigation of medical devices for human subjects-Good clinical practice
  • Klaas van't Klooster - Clinical Manager, JnJ Medical
  • Understanding and aligning with the current revisions of the upcoming third (2020) edition of the ISO 14155
  • Examining the differences between the 2011 and 2020 editions
  • Evaluating the ISO 14155 alongside MDR Gap Analysis
  • Implementing and complying with the changes in the ISO 14155
15:40 - 16:15 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Shedding Light on the Progress of Medical Device Regulation in South Africa
  • Deepa Maharaj - African Regulatory Director, GSK,
  • Avanthi Bester - Regulatory Affairs Manager Africa, Becton Dickinson
  • Updates on the draft regulations for medical devices and its impact on industry
  • Examining the guidelines for licensing, safety and performance and classification of medical devices and IVDs
  • Building a model for successful device registration in South Africa
15:40 - 16:15 35 mins
Info
Drug Device Combination Products
Regulatory Updates from the FDA on Drug Device Combination Products (presentation to be delivered by teleconference)
  • John Barlow Weiner - Associate Director for Policy, Office of Combination Products, Food and Drug Administration, US
  • Updates on combination products policy
  • Recent developments in premarket review (e.g., procedures, pathways, regulatory expectations)
  • Recent developments in postmarket regulation (e.g., manufacturing, postmarket safety reporting)
15:40 - 16:20 40 mins
TRAINING COURSE: US Regulatory Affairs for Medical Devices
Audits and Inspections
16:15 - 16:50 35 mins
Info
Clinical Outsourcing for Medical Device Trials
PANEL: Examining different trial models and assessing the benefit of outsourcing v’s in-house
  • Early stage considerations: Determining the nature of the trial
  • Examining outsourcing options, full service v’s specific activities
  • Strategies for minimising costs when deciding on your outsourcing model
  • Exploring the options for site selection and patient recruitment: outsourcing v’s in-house
16:15 - 16:50 35 mins
Info
Medical Device Regulatory Affairs in Emerging Markets
Panel Session: The Challenges and Opportunities for SaMD and Electronic Devices in the Emerging Markets
  • Kelvin Koh - Director APAC Regulatory Affairs, Terumo BCT
  • Reviewing the current regulatory landscape for electronic devices, Software as Medical Devices (SaMD) and Cyber Security
  • Comparing regulations in the established and emerging markets
  • Country Highlights: Australia, China and Russia
  • Discussing the current challenges faced when registering these devices
  • Assessing the future of medical technology & software regulation in the emerging markets
16:15 - 16:50 35 mins
Info
Drug Device Combination Products
Challenges faced by global organizations to comply with PMSR Requirements
  • Khaudeja Bano - Head of Medical Affairs, Abbott Molecular, US
  • Essential Global Regulatory Alignment needed
  • Highlight the challenges and solutions faced by industry in a global environment
  • Best practices to streamline compliance for successful implementation
  • Risk-based approach to PMSR decision-making – Roles / Responsibilities


16:20 - 16:50 30 mins
Info
TRAINING COURSE: US Regulatory Affairs for Medical Devices
Post approval considerations in the US
  • Post-Market Surveillance
  • Vigilance
  • PMCF
16:50 - 17:00 10 mins
End of conference day four