RAPS Regulatory Converence Europe 2019

Agenda

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Schedule at a Glance

Opening Joint Plenary Session: Thought Leader Discussion Panel – Regulatory Challenges

Panelists: Gert Bos, Qserve, Bassil Akra, TÜV SÜD Product Service GmbH, Oliver Bisazza, MedTech, Sabina L. Hoekstra-van den Bosch, Central Committee for Research Involving Human Subject (CCMO), Graeme Tunbridge, Medicines & Healthcare Products Regulatory Agency, Valerie Nys, Federal Agency of Medicines and Health Products (FAMHP) and EMA, EU Competent Authority and European Commission invited​, Erik Hansson, European Commission.

New medical devices regulations (MDR, IVDR) and other regulatory developments in Europe significantly impact EU market access for device, IVD, combination product and pharmaceutical products. Hear the latest critical insights from prominent thought leaders and influencers; authorities, regulators and industry representatives will highlight what’s high on their radar and action lists. Concise summary presentations from experts followed by interactive panel with audience participation to guide understanding of the requirements and discuss implementation challenges.
  • A Manufacturer's View: Regulatory Strategy for Migrating Product Portfolio of High-risk Devices to Medical Devices Regulation Requirements
    Session Leaders and Speakers: Sophie Tabutin, W.L. Gore & Associates and Patrick Biggerstaff, W.L. Gore & Associates, Inc.
    • Objectives:
    1. Participants will be able to understand the main new requirements introduced by the Medical Devices Regulation (MDR) that have to be accounted for in their regulatory strategy.            
    2. Participants will be able to better understand the potential impact of new requirements such as the clinical evaluation consultation procedure on their regulatory strategy and associated timings.         
    3. Participants will be able to evaluate if their current strategy needs revising in light of the latest understanding of the requirements and associated timelines.
 
  • Can EU Regulations Requirements on NBS Organization and Certification Services Modify the Relationship with the Manufacturers and Product Conformity Demonstration
    Session Leaders and Speakers: Corinne Delorme, GMED Group LNE and Olivier Lantres, Fieldfisher
    • Objectives:
    1. Understand how the MDR/IVDR requirements applicable for NB can have an impact on the relationship. 
    2. Understand how the MDR/IVDR requirements applicable for NB can have an impact on the demonstration of the conformity of QMS and products.        
    3. Define an efficient communication plan for NB.
 
  • GCP inspections of Clinical Investigations Under the MDR
    Session Leader: Sabina L. Hoekstra-van den Bosch, Central Committee for Research Involving Human Subject (CCMO)
    Session Speakers: Tim De Schutter, Federal Agency of Medicines and Health Products, Steve Eglem, AFMPH (Competent Authority of Belgium), and Manon Gielkens, Medtronic
    • Objectives:
    1. Explain the legal context of clinical investigations of medical devices.
    2. Describe what to expect from GCP inspections of clinical investigations of medical devices.
 
  • Impact of MDR on Self-certification: NCA point of View
    Session Leader and Speaker: Katrien A. Martens, Federal Agency of Medicinces and Health Products (FAMHP) - DG Inspection
    • Objectives:           
    1. Define requirements for self-certification under the MDR.
    2. Understand how the MDR could be implemented in case of self-certification.
 
  • Implementation of the New Obligations of Economic Operators under the European Medical Device Regulation
    Session Leader: Philippe Lartigue, GE Healthcare
    Session Speakers: Philippe Lartigue, GE Healthcare, Phillipe Soly, Philips, and Angele Taormina, GE Healthcare
    • Objectives:
    1. Understand the new obligations of economic operators introduced by the MDR and their challenges.     
    2. Explain how to move forward in answering the new obligations of economic operators while limiting the risk of duplications and overlap between those operators.
 
  • Practical Implementation of the Person Responsible for Regulatory Compliance Role
    Session Leader and Speaker: Leo Hovestadt, Elekta
    • Objectives:
    1. Participants will understand how to implement the PRRC role; liability implications of the role, including the influence of local law on the role, as well as when to implement the PRRC role and what the influence is of economic operators on the role.
 
  • Clinical Evaluations: Practical Advice on Gold-Standard Literature Reviews and Overcoming Major Logistical Challenges
    Session Leaders and Speakers: Leo Hovestadt, Elekta and Isabella Steffensen, Thera-Business
    • Objectives:
    1. Understand and apply best practices for completing the literature review component of CERs.     
    2. Establish standard, repeatable processes for conducting literature reviews throughout their organization.
    3. Consistently and efficiently produce and maintain fully compliant and audit-ready literature reviews.
 
  • Substance-Based Medical Devices and the Regulatory Implications of the EU Medical Device Regulation (EU 2017/745)
    Session Leaders and Speakers: Anja Wiersma, mi-CE consultant and Inette Nieveen, Qserve Group
    • Objectives:
    1. Describe what are the new requirements for the substance-based medical devices comparing the Medical Device Directive (MDD) with the Medical Device Regulation (MDR).
    2. Prepare gap analysis of the current products placed on the market and to show compliance with the EU MDR, rule 21 requirements.
    3. Make regulatory strategic plan on the rule 21 products including the impact of the potential notified bodies decisions not to prioritize these product groups.
 
  • Post-Brexit Medical Devices Regulation
    Session Leaders and Speakers: Paul Brooks, RAPS, Graeme Tunbridge, Medicines & Healthcare Products Regulatory  Agency, Philippe Auclair, Abbott
  • A New Look at EU Pediatric Investigation Plans (PIPs) and FDA Pediatric Study Plans (PSPs)
    Session Leaders and Speakers: Klaus Rose, klausrose Consulting, Pediatric Drug Development & More and Dimitrios Anthanasiou, EURORDIS
    • Objectives:
    1. Participants will be able to acknowledge that most PIP-demanded "pediatric" studies are not pediatric, as the EU defines "children" not physiologically vis-à-vis-drug treatment, but administratively.      
    2. Participants will have learned the historical roots of the PIPs in US pediatric legislation.
    3. Participants will be able to identify the conflicts of interest of FDA, EMA and some researchers in "pediatric" studies that advance academic & regulatory careers, not child healthcare.
 
  • Brexit: The Latest Updates
    Session Leader: AdriaanN. Fruijtier, CATS Consultants GmbH
    Session Speakers: Parastoo Karoon, PAREXEL International and Marie-Helene Pinheiro, European Medicines Agency (EMA)
    • Objectives:
      1. Participants will be able to plan and prepare the change of the Marketing Authorization Holder, variations, clinical trials and other regulatory procedures that may be affected by Brexit, as well as plan and prepare to minimize supply chain issues.
 
  • CHMP Oral Explanations and FDA Advisory Committee Meetings - Understanding Similarities and Differences to Optimize Your Preparation 
    Session Leader and Speaker: Cindy DiBiasi, 3D Communications, LLC
    • Objectives:
    1. Participants will be able to demonstrate a thorough knowledge of the CHMP preparation process and be able to understand and describe the FDA Advisory Committee preparation process.
 
  • EMA's Priority Medicines Scheme (PRIME): How to Make it More Successful
    Session Leader and Speaker: AdriaanN. Fruijtier, CATS Consultants GmbH
    Session Speaker: Marie-Helene Pinheiro, European Medicines Agency (EMA)
     Objectives:
    1. Participants will have a better understanding of the PRIME process and will be better able to select products that could benefit from PRIME and write better designation requests.
 
  • Global Regulatory Challenges during the Development of Investigational Products (IP) based on Genetically Modified Organism (GMO)
    Session Leader and Speaker: Kathryn L. Parsley, Boyd Consultants
    • Objectives:
    1. Participants will be able to define a genetically modified organism (GMO) based Investigational Products (IPs) and provide examples, describe the regulatory framework in Europe and North America for GMO based IP's, and be able to provide European and North American regulatory strategy risks and mitigation strategies based on real life experience for GMO based IP's.
 
  • How to Deal with Global Ambiguity in Regulation of Non-Biological Complex Drug Follow-on Products, Are They Generic, Similar, Or... ?                                                                                                    Session Leader: Pieter Stolk, Lygature - NBCD Working Group                                                 Speakers: H. (Bert) G.M. Leufkens, Lygature – NBCD Working Group and Henrike Potthast, Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM)/Federal Institute for Drugs and Medical Devices
    • Objectives:
      • Discuss the impact of future alignment among regulatory agencies on the topic of Non-Biological Complex Drugs.      
      • Have a clear understanding of the regulatory challenges for the approval of NBCD follow-on versions.
 
  • Medical Device Regulation (MDR, Article 117): Impact on Pharma and Biotech Companies and State-of-Play                                                                                                                                                          Session Leader and Speaker: Beat U. Steffen, Confinis 
    Session Speakers: Gert Bos, Qserve and Armin Ritzhaupt, European Medicines Agency
    • Objectives:
      1. Participants will understand how Article 117 influences their marketing authorization application for a drug-device combination product in Europe, understand the requirements set forth by regulators and notified bodies as well as how to practically address these requirements in their ongoing and upcoming development projects.
 
  • Regulator's Expectations: Quality Risk Management in Pharmaceuticals
    Session Leaders and Speakers: Muhammad Naeem, Indus Pharma Private Limited and Muhammad Zubair, Indus Pharma Private Limited
    • Objectives:
    1. Participants will be able to understand the importance and need to implement quality risk management in the life cycle of the finished pharmaceutical product.
    2. Secondly, they will be able to understand what are different tools and techniques which can be applied to effectively perform quality risk management.         
    3. Finally, participants will be able to successfully implement these tools and techniques in their routine at their assigned job through different examples.
 
  • Trends in Market and Patient Access of Advanced Therapy Medicinal Products (ATMPS) in Ultra-rare Conditions                                                                                                                                               Session Leader: David Schwicker, ORPHA Strategy Consulting
    • Objectives:
    1. Participants will be able to explain the current key challenges and future trends regarding market access, pricing and reimbursement of ATMPs in Europe.
    2. Participants will be able to evaluate the value assessment of ATMPs and discuss the criteria and evidence requirements of the different stakeholders for appraisal, pricing and reimbursement.
    3. Participants will be able to develop an evidence generation strategy including patient engagement and real-world evidence to complement clinical trial data for rapid market access of transformative ATMPs.
  • Clinical Evidence and Clinical Performance Study Requirements Under the New European IVD Regulation
    Session Leader: Maria Donawa, Donawa LifeScience Consulting
    Session Speakers: Daniela Karrer, Donawa Lifescience Consulting and Sandra Bulger, PROSYSTEM
    • Objectives:
      Participants will be able to describe the new IVDR requirements for conducting performance evaluations and clinical performance studies
      2.    Participants will be able to discuss the changes that may be needed in the IVD manufacturer’s quality
      system to meet the new requirements for performance evaluations and clinical performance studies
      3.    Participants will be able to discuss general resource needs for complying with IVDR clinical evidence, performance evaluations and clinical performance study requirements

  • In Vitro Medical Device Regulation: What Do 'They' Expect for Clinical Performance: Focus on Manufacturers IVDs and In-house Developed Devices?                                   Session Leader: Anja Wiersma, mi-CE consultancy
    Speakers: Andreas F. Stange, TÜV SÜD and Kees Maquelin, Afdeling Medische Technologie, Dutch Competent Authority
    • Objectives:​
    1. Describe what is intended by performance evaluation and clinical evidence under the new EU IVDR for both IVDRs and in-house developed tests. 
    2. Prepare gap analysis of the current products placed on the market and or used in the hospitals to show compliance with the EU IVDR.
    3. Make strategic decisions on the gathering of the clinical performance and evaluation data needed for the current products developed and used.
  • Medical Device Single Audit Program and In Vitro Diagnostics: Is it for My Company?
    Session Leader and Speaker: Hilary A. Baldwin, Caris Life Sciences
    • Objectives:
    1. Considerations that need to be given to whether the Medical Device Single Audit Program is appropriate for an organization (e.g., what intended markets to enter, audit cycle, cost, etc.)
    2. Advising of the requirements for Medical Device Single Audit Program, which is especially unknown for most in vitro diagnostic companies    
    3. Better predictability of audit time and format, due to format for Medical Device Single Audit Program audits being readily available.
       
  • SME Concerns About their IVD Transition Under the New IVDR by 2022
    Session Leaders and Speakers: Luc Van Hove, MARACA International bvba and Carole Harris, Biocartis
    • Objectives:
    1. Participants will be able to understand the minimum requirements to transition IVDs.
    2. Participants will be able to perform the required transition steps which lead to NB certification of your IVDs under the new IVDR.
    3. Participants will be encouraged to know how to tackle the major hurdles of transitioning SME legacy IVDs through NB certification under IVDR.
  • The Gloom and Doom of Coming to America: The Reality of Regulatory Pathways, Timelines, and Processes to Reach Approval                                                                                  Session Leader & Speaker: Tracy Eberly, Fang Consulting, Ltd.
    • Objectives:
    1. Understand just how difficult it can be to get your product approved in the United States (US).
    2. Know how to best manage time, money and resources with realistic expectations to get your product on the US market.
    3. Understand how to put the best team in place – covering all perspectives – to ensure your best chance of success in getting your product approved for the US market
 
  • Regulatory Requirements and Field Traceability for Stand-alone Software Products
    Session Leader and Speaker: Amanda Brown, Beckman Coulter
    • Objectives:
    1. Understand the basics of quality system requirements applied to SW products; regulatory impact or assessments required for software patches or updates as well as best practices for software product traceability in the field.
 
  • Organizing, Driving, and Maintaining a Successful MDSAP Audit Process
    Session Leaders and Speakers: Lillie Crotts Thomas, AirStrip Technologies Inc.,and Sam Rajkumar, Exact Imaging
    • Objectives:
    1. Participants will be able to apply organizational and efficient techniques to prepare for and successfully complete an MDSAP audit.    
    2. Participants will understand the scoring methods and the implications of those scoring methods on their future compliance risk.
    3. Participants will be able to apply MDSAP methods to internal audit methods to more fully entrench the MDSAP audit process clearer to their organization.
 
  • More Emphasis on Toxicological Risk Assessments in Medical Device Safety Evaluation
    Session Leader and Speaker: Albrecht Poth, knoell Germany GmbH
    Session Speaker: Anja Ramisch, knoell Germany, GmbH
    • Objectives:
    1. Understand the most significant changes on ISO 10993-1, -17, -18 and their consequences.
    2. Structure and compile a toxicological risk assessment and understand useful tools for toxicological evaluation.
    3. Benefit from strategies and real-world experiences with regulatory agencies in the field of biological and toxicological risk assessments.
 
  • Global Regulatory and Clinical Strategies: A New Paradigm for Integrated Product Design and Development?                                                                                                                           Session Leader: Robin Stephens, Psephos Biomedica
    Session Speakers: Semih Oktay, CardioMed Device Consultants, LLC and Chao Xu, JMedTec
    • Objectives:
    1. Articulate the key elements that should be considered in developing appropriate global regulatory and clinical strategy for innovative new medical devices.        
    2. Address business needs and develop an appropriate global regulatory and clinical strategy for innovative new medical devices.
 
  • How to Prepare for China Overseas Inspections
    Session Leaders and Speakers: Gert W. Bos, Qserve and Zeli Yu, Yuzeli Medtecconsultant, Inc.
    • Objectives:
    1. Participants will be able to understand why a manufacturer might be selected to be inspected by NMPA.       
    2. Participants will be able to understand how a manufacturer can prepare for inspections for a successful outcome.             
    3. Participants will be able to review the necessary post-inspection activity that will enable them to respond to NMPA to avoid further regulatory action such as prohibiting imports.
 
  • Cultural Intelligence for the Global Regulatory Affairs (RA) Professional
    Session Leaders and Speakers: Susan Hibbeln, Network Partners, Lilianna Hibbeln, Medline
    • Objectives:
    1. Understand the meaning of cultural diversity and intelligence, the difference between cultural differences and stereotyping, and, learn the technical and soft skills for an effective culturally diverse work environment.
IVDR Workshop:  The New EU IVDR Regulatory Paradigm
8:00 – 17:00
 
8:00 Registration
 
8:30 - 9:00 Welcome
Determining the Need of the Attendants
Open Questions/ Experiences/ Open Cases
 
Anja Wiersma, mi-CE consultancy
9:00 – 9:30 Overview of the New Regulation:  
  • Outline of the IVDR
  • Strategic Timelines
  • Implementation of the New Regulation at CA and Notified Bodies
 
Andreas Stange, TÜV SÜD
9:30 Coffee
9:30 - 11:00 Interactive Workshop on Legacy Products and Transition Strategy
 
Simon Richards, Abbott Diagnostics Business
11:00 - 12:30  Interactive Workshop IVDR General Safety and Performance Requirements
 
Andreas Stange, TÜV SÜD
12:30 – 13:15
 
Lunch
13:15 – 14:45 Interactive Workshop IVDR and Economic Operators: Importer, Distributor EU REP.
 
Dirk Stynen, Qarad BVBA
14:45 – 15:00 Break
 
15:00 – 16:30 Interactive Workshop on Clinical Evidence, PMS and Performance Evaluation Requirements IVDR
 
Anja Wiersma, mi-CE Consultancy  
16:30 – 17:00 Closing Panel Discussion and Q&A - All speakers
 
17:00 Closing meeting
 

MDR Workshop:  Transitioning to the EU MDR and Managing Legacy Devices Implementation of the MDR
08:00 – 17:00
 
8:00 Registration
 
8:30 – 9:00 Welcome
Determining the Need of the Attendants  
Open Questions/ Experiences/ Open Cases
 
Gert Bos, Qserve Group
9:00 – 9:30 Overview of the New Regulation:  
  • Outline of the MDR
  • Strategic Timelines
  • Implementation of the New Regulation at CA and Notified Bodies
 
Bassil Akra, TÜV SÜD
9:30 Coffee
9:30 - 11:00 Interactive Workshop on Legacy Products and Transition Strategy
 
Philippe Auclair, Abbott 
11:00 - 12:30  Interactive Workshop MDR General Safety and Performance Requirements
 
Gert Bos, Qserve Group
12:30 - 13:15
 
Lunch
13:15 Interactive Workshop MDR and Economic Operators: Importer, Distributor EU REP
 
Philippe Auclair, Abbott 
14:45 – 15:00 Break
 
15:00 – 16:30 Interactive Workshop on Clinical Evidence, PMS and PMCF Requirements MDR
Bassil Akra, TÜV SÜD
16:30 – 17:00 Closing panel Discussion and Q&A - All speakers
 
17:00 Closing meeting