ANNUAL SYMPOSIA AMSTERDAM - TOPRA · pharmacovigilance under scrutiny The European Commission is...

Human Medicines | Medical Devices | SME Day | Parallel Sessions

W toprasymposium.orgE [email protected] +44 (0)20 7510 2560F +44 (0) 207 537 2003

28–30 September 2016Hilton Amsterdam Hotel Apollolaan 138, Amsterdam, 1077 BG, NetherlandsT +31 20 710 6000

ANNUAL SYMPOSIA AMSTERDAMPROGRAMME 2016

1 Details correct at time of going to press.

ANNUAL SYMPOSIUM BERLIN 2015ANNUAL SYMPOSIA AMSTERDAM | PROGRAMME 2016

HUMAN MEDICINES Catherine Akers – Amgen, UKAnne De Bock – AstraZeneca, Belgium (chair)Stan van Belkum – Deputy Director, MEB, The NetherlandsJudith Creba – Novartis Pharma AG, SwitzerlandMargareth Jorvid – LSM Group, Sweden (co-chair)Carlos Langezaal – Eisai, USChristine Mayer-Nicolai – Merck KGaA, Germany Dorine Mulder – Dorian Regulatory Affairs BV, The Netherlands

MEDICAL DEVICESMargareth Jorvid – LSM Group, Sweden (Chair)Koen van der Kroef Ministry of Health, Welfare and Sport (VWS), Department of Medicines and Medical Technology (GMT), The NetherlandsStan van Belkum – Medicines Evaluation Board (MEB), The Netherlands Theresa Jeary – LRQA, UKJanine Jamieson – JCombinations AB, Sweden Tim Chesworth – Astra Zenenca, UKGert Bos, Qserve Group BV, The NetherlandsNick Baker – LRQA, UK

SME DAYMargareth Jorvid – LSM Group, Sweden (Chair)

WELCOME

Dear Delegates,

On behalf of the organising committee, welcome to Amsterdam, and welcome to the 2016 TOPRA Annual Symposium.

True to tradition, this Annual Symposium is organised together with the Agency of our host country, the Medicines Evaluation Board in The Netherlands. Our special thanks go to Hugo Hurts, Executive Director of the MEB, and Stan van Belkum, Deputy Head of the Dutch Agency.

Today, more than ever before in the pharmaceutical regulatory framework, patients have been placed more at the centre of drug development, and rightly so. That’s why we’ve chosen as our theme for this key event for regulatory professionals: ‘Regulatory response to public health needs.’

True to form, this Symposium offers a comprehensive selection of the latest insights on regulatory affairs and regulatory science topics presented by experts from health authorities and industry from across Europe and beyond. In their presentations, all of these experts share a wealth of knowledge and experitise, and will answer your questions during panel discussions.

There will also be plenty of opportunities for networking and socialising during breaks and evening events, stimulating continued interactions and discussions with colleagues from regulatory agencies, industry and academics.

I would also like to take this opportunity to thank everyone who made this event possible. In particular, I’d like to thank our speakers from health authorities, industry, notified bodies, academia and patient groups for their support.

Finally, my thanks go to the TOPRA staff team and the members of the different working groups for their efforts and their collaboration to make this event successful.

I wish you all an excellent, stimulating and exciting event.

Thank you.

Anne De Bock – Chair of the TOPRA Annual Symposium 2016 Working Party

WORKING PARTIES

CONTENTS

WelcomeSchedule at a glanceHuman MedicinesMedical DevicesParallel SessionsSME DayFloorplanExhibitor profile

1 2 3–7 8–10 11–12 12 13–14 15–16

STUDENT POSTERS

Each year TOPRA invites students to submit a scientific poster of their own planned or completed research for presentation. These will be on display in the foyer throughout the Symposium and can also be viewed at toprasymposium.org/posters

2Details correct at time of going to press.

SCHEDULE AT A GLANCE

WEDNESDAY 28SME SME SESSION 10.00 – 11.30 This session is open to all Symposium delegates. SME delegates join the Human Medicines Symposium at 12.30

Registration 11.30 – 12.30 Registration, exhibition and refreshments

Welcome 12.30 Welcome to 2016 Symposium

Annual Lecture 12.40 TOPRA Annual Lecture 2016: Addressing public health needs: A Dutch perspective

HM SME SESSION 1 13.15 – 14.45 The HMA’s Multi Annual Work Plan

HM SME SESSION 2 15.15 – 17.10 Current legislation for orphan drugs, paediatrics and pharmacovigilance under scrutiny

Break 17.10

HM SME SESSION 3 17.40 – 19.10 Early access schemes

Networking Dinner 19.10 Meet your colleagues for drinks and dinner with a Dutch theme in the Exhibition Hall

THURSDAY 29Welcome and introduction 08.55

HM SESSION 4 09.00 – 10:30 Clinical Trial Regulation: Implementation and Database

Break 10.30

Introduction 11.05 Introduction to Medical Devices Symposium and joint Human Medicines sessions

HM SES. 5 MD SES. 1 11.15 – 12.45 Therapies of the future: How can digital health enable better patient outcomes?

PS PARALLEL SESSION 1 11.15 – 12.45 Global approaches to accelerate your product development programme and registration while keeping it up-to-date.

Lunch 12.45 – 14.00

HM SES. 6 MD SES. 2 14.00 – 15.30 Drug-Device Combination Products – Convergence of medical devices and pharmaceuticals

PS PARALLEL SESSION 2 14.05 – 17.35 The TQT Study – Is it really necessary?

Break 15.30

HM SESSION 7 16.05 – 17.35 Regulatory science

MD SESSION 3 16.05 – 17.30 Risk management

PS PARALLEL SESSION 3 16.05 – 17.30 Clinical trials

TOPRA Board update 17.35 TOPRA Board update and announcement of TOPRA Board election results and student poster winners

Networking drinks 18.15 Networking drinks in Exhibition Hall followed by freedom to explore Amsterdam

FRIDAY 30Welcome and introduction 08.55

HM SESSION 8 09.00 – 10.30 Biosimilars

MD SESSION 4 09.00 – 10.30 The new EU Medical Device Regulation: Impact on notified bodies and industry

Break 10.30

HM SESSION 9 11.15 – 12.45 Ecotoxicity

MD SESSION 5 11.00 – 12.40 In vitro diagnostics (IVDs), the new regulation, and companion diagnostics

PS PARALLEL SESSION 4 11.15 – 13.00 TOPRA professional development café

Close of Medical Devices Sym. 12.40

Closing remarks by MEB 12.45

Close of Medicines Symposium 12.55 Thomas Kühler, TOPRA President

SME SME DAY HM HUMAN MEDICINES MD MEDICAL DEVICES PS PARALLEL SESSION




HM HUMAN MEDICINES PROGRAMME

WEDNESDAY 28

11.30 – 12.30 Registration, exhibition and refreshments12.30 Welcome to 2016 Symposium

Anne De Bock – AstraZeneca, Belgium, and 2016 Symposium Chair Hugo Hurts – Executive Director, MEB, The Netherlands

12.40 TOPRA Annual Lecture 2016: Addressing public health needs – a Dutch perspectiveDr Marcel van Raaij – Director, Medicines and Medical Technology, Ministry of Health, The Netherlands

SESSION 1 13.15 – 14.45The HMA Multi Annual Work Plan

Last year, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) jointly developed a high-level strategy for the EU regulatory network. Following feedback from stakeholders, this initiative – Strategy to 2020 – was adopted.

As a next step, the HMA then draft ed a Multi Annual Work Plan (MAWP), with key themes identifi ed and the setting of objectives and realistic goals. During the Dutch and Slovakian EU presidencies in 2016, the MAWP highlighted four topics as high priority: antimicrobial resistance (AMR); availability of appropriately authorised medicines; innovation and access to new medicines; and optimisation of regulatory operations.

This session off ers an insight into the plans of action and fi rst results following a focus on three of these top priorities. It will outline next steps and timelines in this important process towards 2020.

Chair: Hugo Hurts – Executive Director, MEB, The Netherlands

13.15 Introduction• Availability of medicines registered in an optimal way and

of good quality • Innovation and access to new medicines • Regulatory optimisation (CMDh topic).

13.20 Innovation and access to new medicinesIan Hudson – CEO, MHRA, UK • Flexibilities within the EU regulatory framework for the

early access of innovative products at national level, ie, the participation in clinical trials or off -label use as well as further optimisation of conditional approval, exceptional circumstances approval or accelerated assessment

• An integrated view of NCAs’ innovation offi ces in relation to the early identifi cation of promising developments and their integration in the EU adaptive pathways, national designation of small and medium-sized enterprises (SMEs).

13.45 Availability of appropriately authorised medicines Andreja Cufar – Executive Director of the Public Agency of

the Republic of Slovenia for Medicinal Products and Medical Devices (JAZMP), Slovenia• How to ensure the availability of appropriately authorised

human medicines in member states, such as Slovenia• Consequences of market failure where patient access to

eff ective and aff ordable medicines is endangered (eg, vaccines, antidotes, ‘old’ nationally authorised medicines, etc).

14.00 Regulatory optimisation (CMDh topic) Hugo Hurts – Executive Director, MEB, The Netherlands14.20 Panel discussion

Moderated by chair with today’s speakers plus invited guests – this is your opportunity to explore the topic more fully.

14.45 Break

SESSION 2 15.15 – 17.10Current legislation for orphan drugs, paediatrics and pharmacovigilance under scrutiny

The European Commission is contemplating reviews of the Orphan Drug and Paediatric Regulations, as the plans for these Regulations are still unclear. Meanwhile, the Pharmacovigilance legislation has been in force for some time now, but discussion is still needed on some of its implementation measures.

This session aims to provide a status update on current discussions at a European level as well as insights into news on international harmonisation from ICH.

Chair: Christine Mayer-Nicolai – Merck KGaA, Germany

15.15 Introduction15.20 Orphan Medicinal Products Regulation Olga Solomon – European Commission, Belgium

• Commission Notice on aspects of the application of Articles 3, 5 and 7 of Regulation (EC) 141/2000 on orphan medicinal products

• Revision of similarity concept in the context of the orphan medicinal products legislation – status.

15.45 Paediatrics Regulation Olga Solomon – European Commission, Belgium

• The second report from the European Commission on the Paediatric Regulation (to be fi nished in 2017):

• Purpose and context of the report • Preparatory work and next steps including public

consultation.16.00 Pharmacovigilance Regulation Kathy Williams – Lead Pharmacovigilance and Regulatory

Excellence, AstraZeneca

• Updates on the new EudraVigilance (EV) system




• Update on the Pharmacovigilance Risk Assessment Committee (PRAC) public hearings

• Outcome of the pilot PRAC interaction with Scientifi c Advice Working Party (SAWP) and industry perspective

• Industry views on recording and reporting of off -label use• Medical literature monitoring.

16.20 Update on recent ICH developments Lenita Lindström Gommers – European Commission,

Belgium

• Update on ICH reform/changes in the ICH governance• Outcomes of the recent ICH Lisbon Assembly meeting• Discussion of ongoing changes to ICH topics• Presentation of new topics to be considered by ICH.

16.45 Panel discussion17.10 Break

SESSION 3 17.40 – 19.10Early access schemes

A number of promising initiatives have started over the past year to use the existing EU regulatory tools more eff ectively, and to improve safe and timely access of medicines for patients.

The EMA’s new priority medicines scheme, PRIME, is expected to contribute signifi cantly to support development of innovative medicines for unmet medical needs. Adaptive pathways are another tool that can help industry optimise regulatory strategy. Early access schemes may have an eff ect on subsequent decisions on pricing and reimbursement.

This session will cover early access tools and the Health Technology Assessment perspective.

Chair: Dorine Mulder – Director, Dorian Regulatory Aff airs BV, The Netherlands

17.40 Introduction17.45 Update on the Commission’s activities for Safe and Timely

Access to Medicines (STAMP) Olga Solomon – European Commission, Belgium

• Adaptive pathways• Conditional marketing authorisation• Accelerated assessment.

18.05 Early access initiatives – an EMA perspective Tomas Salmonson – MPA, Sweden and CHMP chair

• PRIME• Adaptive pathways.

18.25 EUnetHTA and Zorginstituut Nederland perspectives on early access schemes

Ad Schuurman – EuNetHTA and Dutch National Health Care Institute, ZIN, The Netherlands

• When will society benefi t?• Is it a European or national/regional decision?

18.45 Panel discussion Moderated by David Jeff erys – EISAI, with this session’s speakers.

19.10 Symposium networking dinner Meet your colleagues for drinks and dinner with a Dutch

theme in the Exhibition Hall.

THURSDAY 29

08.55 Welcome and introduction

SESSION 4 09.00 – 10.30Clinical Trial Regulation: Implementation and database

The EU Clinical Trial Regulation (CTR) is due for implementation in October 2018 at the latest. This requires a fully functional IT system, the new EU portal and database. During the year, stakeholders have their fi rst view and experience of this new system via participation in phases of user acceptance testing, as the system is gradually being built.

Preparations ongoing at the EU member state level also include implementation of national pilot processes to help prepare for the new system. In addition, a number of guidance documents to facilitate implementation are due for release for consultation during the course of the year.

In this session, overall progress and developments will be examined from the diff erent stakeholder perspectives.

Chair: Judith Creba – Executive Director, EU Regulatory Strategy, Novartis Pharma AG, Switzerland

09.00 Introduction09.05 Moving towards implementation: Overview of progress so far Massimiliano Sarra – Research and Clinical Trial Offi ce, Italian

Medicine Agency (AIFA), Italy

• Introduction and main changes in the new regulation

• Bridging between the current and the new – progress on VHP

• CTFG implementation activities.

09.25 Implementation of the Clinical Trial Regulation in member states

Cees de Heer – Executive Director, Centrale Commissie Mensgebonden Onderzoek (CCMO), The Netherlands

• Similarities and diff erences in reviewing of application dossiers by member states (MS)

• Progress and challenges with implementation of the Clinical Trial Regulation (CTR)

• Harmonisation of formats and working procedures.




09.50 Industry preparedness – what should you be aware of? Isabelle Clamou – Regulatory Aff airs Director, Global Regulatory and R&D Policy, Amgen, Belgium

• EU Portal and database user acceptance testing• Implementation measures/consultations• National developments.

10.05 Panel discussion Moderated by the chair, when this session’s speakers will take questions from the floor.

10.30 Break

11.05 Introduction to Medical Devices Symposium and Joint Human Medicines SessionsMargareth Jorvid – Methra Uppsala AB, LSM Group, Sweden and Bas van den Dungen – Director General, Ministry of health, welfare and sport, The Netherlands

SESSION 5 11.15 – 12.45Therapies of the future: How can digital health enable better patient outcomes?

How can the power of the digital revolution be harnessed to improve medicines and deliver better patient outcomes? Many companies have taken up this challenge; however, navigating complex and oft en uncharted regulatory pathways is a major hurdle.

This session aims to highlight the areas in which regulators and industry need to collaborate and begin to develop a path forward.

Chair: Tim Chesworth – Senior Director, Combination Products Regulatory Aff airs, AstraZeneca, UK

11.15 Introduction

11.20 A regulatory agency perspective on current and future regulation of soft ware and Apps

Wolfgang Lauer – BfArM, Germany

• Opportunities and risks of medical Apps• Current status of Apps as medical devices• Outlook on the new European regulation.

11.45 An industry perspective on developing soft ware/Apps for use in conjunction with medicinal products

Matt Bonam – Project Director, Intelligent Pharmaceuticals, AstraZeneca, UK

• Current approach and the diffi culties faced• What has worked well and what has not?

12.05 Perspective from a digital health/soft ware system developer

Raffi Krikorian – VP, Quality Assurance and Regulatory Aff airs, Voluntis, France

• Why is it important that medical Apps are regulated?• How to apply the device regulations successfully• How to work with partner companies• Other challenges

12.25 Panel discussion Moderated by this session’s chair, speakers will take questions from the floor.

12.45 Lunch in the Exhibition Hall

SESSION 6 14.00 – 15.30Drug-device combination products – Convergence of medical devices and pharmaceuticals

It is oft en said that there are great challenges at the interface of medtech and pharma and particularly in Europe, with its history of separate regulatory pathways. However, there are many good reasons why medical devices and medicinal products are regulated diff erently.

This session looks at the similarities and diff erences in regulation, and how regulatory professionals can work together to break down barriers, increase understanding and improve collaboration as we move into an exciting future.

Chair: Janine Jamieson – Combinations AB, Sweden

14.00 Introduction14.05 Innovative and borderline medical devices/medicinal

products Robert Geertsma – RIVM and Co-Chair of the New and

Emerging Technologies Working Group (N&ET WG), The Netherlands

• New and emerging medical devices trends (N&ET WG)• Drivers: Nanotechnologies, information communication

technology (ICT) developments, diff usion of high-tech care to domiciliary environment and 3D printing

• Growing number of borderline and combination products.

14.25 Innovative and challenging drug delivery devices – perspective from a big pharma devices engineer

Mark Chipperfi eld – Corvus Device Ltd, UK

• Typical pharma strategies for drug delivery product presentations

• What are the biggest pharma challenges in dealing with these strategies

• Bringing medtech and pharma together.


14.45 The FDA Offi ce of Combination Products (OCP) and new FDA commissioner focus on combination products

John (Barr) Weiner – Associate Director for Policy and Product Classifi cation Offi cer, FDA, US (via teleconference)

• History and rationale for setting up the OCP• Learning experiences and communication with

stakeholders• Current status and plans for the future of combination

products.

15.05 Panel discussion Moderated by this session’s chair with invited guest Waldo Weijers and this session’s speakers.

15.30 Break

SESSION 7 16.05 – 17.35Regulatory science

Our regulatory system, the products to be authorised and our national, European and international relations have become increasingly complex over the past decade. This makes regulatory decision-making the most challenging topic of our network.

Prof Bert Leufk ens says ‘regulatory decision making and regulatory science are two sides of the same coin. At the end, patients will benefi t from investing in sound regulatory science – it’s the R&D of the MEB.’ The MEB has a good tradition of bringing together a strong academic network and collaboration with external parties, by seeking partnerships for either short-term projects or longer PhD trajectories.

In this session the importance of regulatory science through strategic networking will be explained and examples will be given of the eff ect of the science on the day-to-day work and decision-making in the regulatory world.

Chair: Dr Christine Gispen-de Wied – Head Scientifi c Programme Board, MEB, The Netherlands

16.05 Introduction – Academic networking, opportunities and spin-off s

Christine Gispen – Head Scientifi c Programme Board, MEB

• Collaborating for reciprocal excellence• Learning and teaching from inside out and the other way

around• Sharing for better understanding and alignment of two

worlds.

16.10 Keynote Speech: Regulatory science and early dialogue Jan Mueller-Berghaus – CHMP member PEI, Germany

• Animal studies – the start of a long process towards drug registration

• Poor animal models drive bad decision-making and progress suboptimal drugs or mistakenly stop drugs from entering trials

• Identifying when animal studies are not needed and which models will improve

• Improvement of the (nonclinical) regulatory system is possible with input of all stakeholders.

16.25 Methodology of regulatory science Prof Dr Bert Leufk ens – Chair of the MEB, The Netherlands

16.40 Animal studies, 3R and more Peter van Meer – Post-doctoral researcher, Utrecht

University, The Netherlands

16.55 Reflection on this session’s topics Merete Schmiegelow – Senior Director Regulatory Policy,

Novo Nordisk and Honorary Industrial Ambassador in Regulatory Science at the University of Copenhagen, Denmark

• Copenhagen Center for Regulatory Science – CORS: Why, what, when

• CORS defi nition of RS – global alignment? • Global picture of countries/regions working with RS

(education/research)• Can more effi cient, evidence-based, focused and

transparent RS partnerships stop the ever-increasing demands of data requirements for drug approval as well as post-authorisation life cycle?

17.10 Panel discussion Moderated by this session’s chair – speakers will take questions from the floor.

17.35 TOPRA Board update, Board election results and announcement of student poster winners

18.15– 19.15 Networking drinks in the Exhibition Hall






FRIDAY 30


SESSION 8 09.00 – 10.30Biosimilars

In 2006 the EMA was the fi rst regulatory agency to approve Omnitrope as a biosimilar. Over the past decade the EMA’s experience with biosimilars has increased, and many countries have now adopted their own regulations and policy oft en based on EU guidance. However, despite biosimilars being available for 10 years, their uptake into clinical practice remains slow and studies have shown that the knowledge and confi dence of both prescribers and patients with the use of these products remains low.

This session will compare biosimilar regulation and policy around the globe, focusing on the key considerations for biosimilars development, registration and importantly how regulators and biosimilar developers are engaging with prescribers and patients to enable full utility of these products.

Chair: Catherine Akers – Senior Manager Regulatory Aff airs, Amgen, UK

09.00 Introduction09.05 EU – leading the way in biosimilar regulation? Prof Dr Bert Leufk ens – Chair of the MEB, The Netherlands

• Brief history of EU biosimilar framework• Interaction between EMA/CHMP and member states on

biosimilar issues• Communication and building trust with prescribers and

patients.

09.25 Is there harmony in the rest of the world? Sony Prasad – Senior Manager, Worldwide Regulatory

Strategy Biosimilars, Pfi zer, UK (representing IFPMA)

• Which countries and when• Following the EU/FDA or stand-alone requirements –

similarities and diff erences• The future – are we getting closer together or further

apart?

09.45 Developing a biosimilar for multiple markets – tricks of the trade

Richard Peck – VP Regulatory Aff airs, Lupin, Switzerland

• Challenges/opportunities for biosimilar developers• Scientifi c advice FDA vs EMA – is there any common

ground?• Post-authorisation challenges and ensuring market share.


10.30 Break

SESSION 9 11.15 – 12.45Ecotoxicity

Pharmaceuticals in the environment are getting increasing attention from regulatory and environmental agencies across Europe.

This session will examine the latest trends and insights while providing some examples of how industry can collaborate to share assessments and costs across companies for a certain molecule.

Chair: Anne De Bock– AstraZeneca, Belgium

11.15 Introduction11.20 Pharmaceuticals in the environment (PIE): Concerns,

regulatory challenges and industry’s Eco-Pharmaco-Stewardship (EPS) Initiative

Jason Snape – AstraZeneca, UK

• How pharmaceuticals enter the environment• Stakeholder concerns associated with PIE• Experiences with the environmental risk assessment of

human medical products• Update on the European Commission strategic review of

PIE• Industry Eco-Pharmaco-Stewardship approach with an

emphasis on extended environmental risk assessment.11.40 Collaborative approaches of industry with regulators and

academic scientists to improve the environmental risk assessment (ERA) framework for human pharmaceuticals

Reinhard Laenge – Bayer

• Pharmaceuticals in the environment: From internal concepts to a public research programme

• Collaborative approach of academia, industry and regulators

• Prioritisation of pharmaceuticals for ERA’s• Proof of concept in a regulatory framework.

12.05 An environmental agency perspective Caroline Moermond – RIVM, The Netherlands

• Regulatory experience with ERAs• Revision of the guideline for ERA• Pharmaceuticals in the environment: the Dutch situation • Approach taken by the Dutch government towards

reduction of pharmaceuticals in the environment.12.25 Panel discussion

Moderated by this session’s chair – speakers will take questions from the floor.

12.45 Closing remarksStan van Belkum – Deputy Director, MEB

12.55– 13.00 Close of 2016 SymposiumDr Thomas Kühler – TOPRA President


MD MEDICAL DEVICES PROGRAMME

THURSDAY 29

10.30 – 11.00 Registration, exhibition and refreshments11.05 Introduction to Medical Devices Symposium and Joint

Human Medicines SessionsMargareth Jorvid – Methra Uppsala AB, LSM Group, Sweden and Bas van den Dungen – Director General, Ministry of health, welfare and sport, The Netherlands

SESSION 1 11.15 – 12.45Therapies of the future: How can digital health enable better patient outcomes?

How can the power of the digital revolution be harnessed to improve medicines and deliver better patient outcomes? Many companies have taken up this challenge; however, navigating complex and oft en uncharted regulatory pathways is a major hurdle. This session aims to highlight the areas in which regulators and industry need to collaborate and begin to develop a path forward.Chair: Tim Chesworth – Senior Director, Combination Products Regulatory Aff airs, AstraZeneca, UK 11.15 Introduction

11.20 A regulatory agency perspective on current and future regulation of soft ware and Apps

Wolfgang Lauer – BfArM, Germany• Opportunities and risks of medical Apps• Current status of Apps as medical devices• Outlook on the new European regulation.

11.45 Developing soft ware/Apps for use in conjunction with medicinal products: An industry perspective

Matt Bonam – Project Director, Intelligent Pharmaceuticals, AstraZeneca, UK• Challenges and opportunities: Approach taken to date and

diffi culties faced• What has worked well? What has not?

12.05 Perspective from a digital health/soft ware system developer Raffi Krikorian – VP, Quality Assurance and Regulatory

Aff airs, Voluntis, France• Why is it important that medical Apps are regulated?• How to apply the device regulations successfully• How to work with partner companies• Other challenges.

12.25 Panel discussion: Digital health and the future This session’s speakers will take questions from the floor.

12.45 Lunch in the Exhibition Hall

SESSION 2 14.00– 15.30Drug-device combination Products – Convergence of medical devices and pharmaceuticals

It is oft en said that there are great challenges at the interface of medtech and pharma and particularly in Europe, with its history of separate regulatory pathways. However, there are many good reasons why medical devices and medicinal products are regulated diff erently. This session looks at the similarities and diff erences in regulation, and how regulatory professionals can work together to break down barriers, increase understanding and improve collaboration as we move into an exciting future.

Chair: Janine Jamieson – JCombinations AB, Sweden14.00 Introduction14.05 Innovative and borderline medical devices/medicinal

products Robert Geertsma – RIVM and Co-Chair of the New and

Emerging Technologies Working Group (N&ET WG), The Netherlands • New and emerging medical devices trends (N&ET WG)• Drivers: Nanotechnologies, information communication

technology (ICT) developments, diff usion of high-tech care to domiciliary environment and 3D printing

• Growing number of borderline and combination products.14.25 Innovative and challenging drug delivery devices –

perspective from a big pharma devices engineer Mark Chipperfi eld – Corvus Device Ltd, UK

• Typical pharma strategies for drug delivery product presentations

• What are the biggest pharma challenges in dealing with these strategies

• Bringing medtech and pharma together.14.45 The FDA Offi ce of Combination Products (OCP) and new FDA

commissioner focus on combination products John (Barr) Weiner – Associate Director for Policy and Product

Classifi cation Offi cer, FDA, US (via teleconference)• History and rationale for setting up the OCP• Learning experiences and communication with

stakeholders• Current status and plans for the future of combination

products.15.05 Panel discussion

Waldo Weijers, MEB, will outline communication on combination products in the Netherlands and join speakers to take questions from the floor – this is your opportunity to explore the topic more fully.

15.30 Break and close of Session 2 Delegates will move to the Medical Devices Symposium room

for Session 3.




FRIDAY 30


SESSION 4 09.00 – 10.30The new EU Medical Device Regulation: Impact on notifi ed bodies and industry

This session will provide an overview of the future regulatory framework, discussing the key changes in the new Medical Device Regulation (MDR). It will examine the consequences of these changes and the impact they will have on notifi ed bodies and companies working with these products. An outline of where we are currently and timelines for implementation will also be presented.Chair: Margareth Jorvid – Methra Uppsala AB, LSM Group, Sweden 09.00 Introduction09.05 The new EU device regulation Erik Hansson – Deputy Head of Unit, European Commission,

Belgium • What does the new Medical Device Regulation include?• Timelines for implementation • What do we do in the meantime?

09.25 Impact on notifi ed bodies Theresa Jeary – Technical Manager, LRQA, UK

• Impact of the new regulation on notifi ed bodies• How the eff ects on notifi ed bodies could impact medical

device manufacturers• Designation, supervision and audits of notifi ed bodies.

09.45 Impact on industry John Brennan – Director Regulations & Industrial Policy,

MedTech Europe, Belgium • Impact on companies working with medical devices• Practical aspects on company portfolios• Resources and future challenges.


10.30 Break

SESSION 3 16.05 – 17.30Risk management

This session will focus on the implementation of risk management. It will begin with a reflection on the diff erent and similar elements in benefi t–risk assessment from the medical device and the pharmaceutical legislations. There will be an exploration of the elements that contribute to the decision if the benefi t–risk ratio is positive, and how to arrive at a fi nal conclusion to safely introduce a product to or keep it on the market.Finally, this session will examine the in-depth risk-based approaches in the new ISO 13485:2016 quality system requirements on medical devices. Chair: Gert Bos – Executive Director, Qserve Group BV, The Netherlands

16.05 Introduction

16.10 Risk management of combination products Tom Sam – Previous Director CMC Regulatory Aff airs, Merck

Sharp & Dohme (retired), The Netherlands • How to match the risk-based approaches from the devices

and medicinal products arenas for combination product development.

16.30 Acceptability of risk and the benefi t–risk determination according to the new MDR

Leo Hovestadt – Senior RA/QA Manager, Elekta Company, The Netherlands • How to determine the benefi t–risk ratio• How to determine acceptability of risk• How to apply the benefi t–risk ratio in the clinical

evaluation.16.50 ISO 13485:2016 implementation Gert Bos – Executive Director, Qserve Group BV, The

Netherlands • How to implement the new risk management requirements

from ISO 13485:2016 beyond development and production.17.10 Panel discussion

Moderated by this session’s chair – speakers will take questions from the floor.

17.30 Return to Human Medicines Symposium room

17.35 TOPRA Board update, Board election results and announcement of student poster winners





SESSION 5 11.00 – 12.40In vitro diagnostics (IVDs), the new regulation, and companion diagnostics

The IVD industry is facing the most substantial change from a regulatory perspective since the fi rst IVD Directive was published in 1998, with most products now requiring some level of notifi ed body involvement.

In addition to the signifi cant changes for the regulation of IVDs, there have been major advancements in the development of personalised medicines, with cancer treatments a particular focus.

The companion diagnostics (CDx) area has seen tremendous technological advancements as techniques have improved in the genetic sequencing/testing area.

With respect to the regulation of companion diagnostics, the IVD Regulation (IVDR) will for the fi rst time require a consultation with medicines agencies (competent authority/EMA) on the medicinal product’s treatment.

The aim of this session is to provide details on the current state of play with the regulation and also share some practical guidance for the approval of a CDx.

Chair: Nick Baker – Technical Manager – IVD, LRQA, UK

11.00 Introduction: Commission update on the IVD Regulation Erik Hansson – Deputy Head of Unit, European Commission,

Belgium

11.10 Notifi ed body perspective Alex Laan – Senior Project Manager Medical Devices, DEKRA,

The Netherlands

Impact of IVDR on notifi ed bodies (NBs): • Planned development of guidance for CDx assessment• Assessment guidance for m-two products • Consultation process for CDx – NB perspective, challenges

and concerns.

11.30 Industry perspective Peter Martin – Senior Director Global Regulatory Aff airs,

Roche Diagnostics, Germany

Update on activities conducted by industry to prepare for the IVDR and assessment by a NB. Session to include work conducted on:• Industry challenges for CDx development• Collaboration with pharmaceutical industry and sharing

good experiences• Changes to existing practice• Types of data already available on CDx and gaps with

requirements of IVDR• Gap analysis work completed and areas requiring

additional eff ort to meet IVDR requirements.

11.50 A competent authority (CA) perspective Stephen Lee – Biosciences Team Manager, MHRA, UK

Setting the scene of the CDx arena:• Defi nition of a CDx• CA evaluation process for the performance evaluation of

the device• Consultation process for CDx – key expectations and

proposed timelines.


12.40 – 13.00 Close of 2016 Medical Devices Symposium




PS PARALLEL SESSIONS

THURSDAY 29

PARALLEL SESSION 11.15 – 12.45Global approaches to accelerate your product development programme and registration while keeping it up-to-date

All pharmaceutical companies look at opportunities to accelerate medicinal product development and bring a product to market as quickly as possible.

In this session, we look at strategies and opportunities from the strategic, operational and labelling aspect of regulatory aff airs.

Chair: Carlos Langezaal – Director Regulatory Aff airs, Eisai, US

11.15 Introduction

11.20 Strategies to support accelerated global development and fi lings

Stefan Ochalski – Senior Director, Regulatory Aff airs, Oncology, Janssen, US

• Start at discovery phase and conduct market analysis• Defi ne regulatory and clinical strategies• Identify global accelerated development/approval

opportunities.11.45 Process for simultaneous global submissions – a

regulatory operations perspective Wil Foster – Director, Global Submissions Management,

Eisai, UK

• Strategies for simultaneous global fi lings• Collaboration and “follow the sun” approach.

12.05 An end-to-end labelling model to improve the entire labelling process

Patricia Lefebvre – Director Regulatory Labelling, Sanofi , France

• What is the end-to-end labelling process? • Process systems with possible milestones and data

points to monitor• Possible issues• Deliverables and criteria to succeed.

12.25 Panel discussion Moderated by chair with with the session speakers – this is

your opportunity to explore the topic more fully.

12.45 Close of session

PARALLEL SESSION 14.05 – 15.30The TQT Study – is it really necessary?

ICH E14 provides recommendations to sponsors concerning the design, conduct, analysis and interpretation of data to assess a drug’s potential to delay cardiac repolarisation. The guidance was revised in December 2015.

In this session, we provide an update on the revision of this guidance, alternative options for a thorough QT study, considerations to be taken into account by a regulatory strategist, documentation and data submission to health authorities and a recent case study.

Chair: Carlos Langezaal – Director Regulatory Aff airs, Eisai, US

14.05 Introduction

14.10 ICH E14 and the changing landscape Borje Darpo– Consultant and Associate Professor of

Cardiology, Karolinska Institute, Sweden and Global Medical Director, iCardiac Technologies, US

• Revision of the E14 Guidance• Can early QT assessment using exposure response

analysis replace the TQT study?

14.35 Regulatory strategist involvement in the TQT assessment Carlos Langezaal – Director Regulatory Aff airs, Eisai, US

• Considerations to be taken into account by a regulatory strategist

• Documentation and data submission to health authorities, specifi cally the US FDA

14.50 Case study: Global strategy to assess the potential of a drug delay repolarisation

Borje Darpo– Consultant and Associate Professor of Cardiology, Karolinska Institute, Sweden and Global Medical Director, iCardiac Technologies, US

• Clinical programme and HPQT analyses conducted to assess the eff ects of lemborexant on cardiac function

• Presentation of results to regulatory agencies to obtain a waiver of conducting a TQT clinical study

15.10 Panel discussion Moderated by chair with with the session speakers – this is

your opportunity to explore the topic more fully.

15.30 Close of session

PARALLEL SESSION 16.05 – 17.30Clinical trials

Chair: Carol Pitcher-Towner – Senior Regulatory Aff airs Director, Alnylam UK Ltd and TOPRA Clinical Trials SPIN

16.05 SPIN Introduction and Scene Setting (with input from industry representatives and Regulatory Agency)

16.20 Discussion groups

Questions for small group discussion will include:

• How are you preparing for implementation of the Clinical Trial Regulation (CTR) in your company?

• What are the key challenges with the CTR? Do you foresee any challenges in relation to CRO partnerships?

• How do we interpret the data transparency aspects of the regulation? And how should we be preparing or it? Are there particular issues for industry regarding the increased transparency requirements?

• What are the challenges of using the new EU portal and database? Have you been involved in the user acceptance testing – what are the key learnings to date?

17.00 Feedback session

Representative from each group will feedback key messages from their discussion and how the CT SPIN could support participants during the CTR implementation phase.

17.25 Conclusion

17.30 Return to Human Medicines Symposium room

17.35 TOPRA Board update and announcement of student poster winners



FRIDAY 30

PARALLEL SESSION 11.15 – 13.00TOPRA professional development café

This informal session will outline ways in which regulatory professionals can develop their own careers or the careers of their staff team using a structured professional development framework.

It will also be an opportunity to learn about new approaches that TOPRA is taking to support regulatory staff and a chance for you to have your say on how this support should develop in future.

Chair: Samantha Alsbury – Head of Professional Development, TOPRA

11.15 Being the best you can be – a career-long approach to professional development

Tacye Connelly – Director of Policy, TOPRA

• Regulatory career stages and why CPD is vital• How can TOPRA help?

11.20 That diffi cult fi rst job – how TRAC Services recruit and train new staff

Jonathan Trethowan – MD, TRAC Services (The Regulatory Aff airs Consultancy) and Past-President of TOPRA, UK

• Recruitment and training challenges• The ‘buddy’ system.

11.35 Widening access to and addressing staff shortages in our profession: Could apprenticeships be the answer?

Samantha Alsbury – Head of Professional Development, TOPRA

• Why apprenticeships?• What are the requirements?• How can I be involved?

11.55 How mindfulness and resilience can improve your professional life

Susan Botfi eld – Careers Consultant, Four Pillars Coaching, UK

12.30 We are all welcome here – why diversity matters in the regulatory profession

Lynda Wight – Executive Director, TOPRA

• What TOPRA is doing to promote diversity• Why does this matter?

Open Q&A and networking session – meet your colleagues and talk about issues of recruitment, training, diversity, and personal development. Demonstrations of the TOPRA personalised CPD recording tool. Opportunities to comment on regulatory competencies, TOPRA’s diversity actions and any other issues of interest.


PS PARALLEL SESSIONS SME SME DAY

WEDNESDAY 28

09.30 Registration and exhibition

SME SESSION 10.00 – 11.30This session is open to all Symposium delegates. SME delegates join the Human Medicines Symposium at 12.30

Chair: Margareth Jorvid – Methra Uppsala AB, LSM Group, Sweden

This session will give small and medium-sized enterprises (SMEs) the opportunity to understand regulatory challenges specifi c to them. Support by the SME Offi ce at the European Medicines Agency (EMA) will be explored and experiences by SME companies shared.

10.00 Introduction10.10 SME Offi ce at the EMA Melanie Carr – Head of Stakeholders and Communication

(ad interim), EMA, UK

• Activities of the EMA’s SME Offi ce • Experience of EMA scientifi c advice process and

centralised procedure• Support to SMEs.

10.40 Experience of a Dutch SME – Prosensa Jasper Renz – Director Regulatory Aff airs, BioMarin

Nederland BV, The Netherlands

• SME challenges • Experience of drug development• Regulatory and administrative assistance• Incentives and support.

11.10 Panel discussion Speakers will take questions from the floor – this is your

opportunity to explore the topic more fully.

11.30 Exhibition, networking refreshments12.30 Delegates join the Human Medicines Symposium

1413 Details correct at time of going to press.Details correct at time of going to press.


HM Human MedicinesMD Medical DevicesPS Parallel sessionsSME SME DayVM Veterinary Medicines

1 Samarind RMS2 Hydrogen3 Schlafender Hase4 Sparta Systems5 SGS

F1 AstraZenecaF2 MakroCareF3 Zwiers Regulatory Consultancy F4 RR DonnelleyF5 Cunesoft

6 Dora Wirth Languages7 Blue-Reg8 ArisGlobal9 10 MAPI Group 11 Extedo

F6 Regulatory Pharma NetF7 TRAC ServicesF8 CK GroupF9 Arriello F10 Medicines for Europe

12 Regulatory Professionals13 ProductLife Group14 Tarius15 Lorenz16 VCLS

F11 EPSAF12 Four Pillars CoachingF13 CerevetF14 Cyton Biosciences

17 Hays Life Sciences18 Veeva Systems19 Xendo

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DIAMOND ROOM

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NASSAU ROOM

BALLROOM A BALLROOM B BALLROOM C

STATEN ROOM

ORANGE ROOM 1

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ORANGE ROOM 4

ORANGE ROOM 6

PAVILION

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C&E CENTRE ENTRANCE

FLOORPLAN

MAIN HALL EXHIBITORS FOYER EXHIBITORS SESSIONSR1 HM, MD, SME registrationR2 Veterinary registrationT TOPRAM Medicines Evaluation BoardSP Student Posters

TOPRA/MEB



1 SAMARIND RMS Samarind is an award-winning solution provider in the life sciences industry. Samarind RMS is the benchmark for ‘the single place of truth’ in regulatory information management and beyond, supplying a single source of information for submission tracking, xEVMPD, eCTD, EDMS, ICSR reporting, medical device registration tracking and UDI, with a clear roadmap to ISO IDMP. Samarind is now part of the Instem Group, the award-winning solution provider. www.samarindrms.com

4 SPARTA SYSTEMS Sparta Systems, an industry pioneer and leading global provider of enterprise software for quality and regulatory management, enables businesses to safely and efficiently deliver their products to market. For more than 20 years, Sparta Systems has been a trusted standard amongst highly regulated industries, used by quality, manufacturing and regulatory affairs professionals to manage regulatory compliance, reduce risk and improve safety across the global enterprise. www.spartasystems.com

7 BLUE-REG Blue Reg is a consultancy company specialised in Drug Development, Regulatory affairs, Quality Management and Pharmacovigilance. Our services can be tailored to meet your needs in terms of consultancy, writing, preparation and submission of Regulatory dossiers. Our flexible approach and dynamic team, with extensive hands-on industry experience, will guide you to project success. www.blue-reg.com

3 SCHLAFENDER HASE Schlafender Hase® is the global leader in computer-driven proofreading. Our Text Verification Tool® (TVT) is the international benchmark for accurate, user friendly text and graphic verification. TVT is currently used by the world’s leading pharmaceutical and medical device companies as well as numerous regulatory bodies to ensure compliant, error-free packaging. www.text-verification.com

6 DORA WIRTH LANGUAGES In-house medical expertise, a proven track record of dedication to the field, and a strong commitment to quality and service all combine to make DWL your reliable partner for global life science translation solutions. DWL has over 50 years’ experience in providing translation services and language consultancy in the following specialist areas: regulatory affairs, clinical research, medical research, medical publishing, medical devices, manufacturing, legal, and marketing communications. www.dwlanguages.com

9 10 MAPI GROUP Mapi is the leading Patient-Centered Research Company serving academia, life science researchers, and the pharmaceutical industry for over 40 years. Mapi’s commitment to patient-focused research is demonstrated not only by our expertise and nearly four decades of service but also through our direct contribution back to the industry. Mapi is among only a handful of global organizations that is capable of engaging with a patients’ complete ecosystem, their HCPs, Patient Communities, payers, and even regulators. And only Mapi has the unique history to make us the most experienced at interacting with all of them. www.mapigroup.com

2 HYDROGEN Specialising in placing exceptional, hard-to-find candidates globally across a number of life sciences functions including: Biometric, Clinical, QA & TechOps, Medical, Regulatory affairs. Our consultants use their market knowledge and expertise to work with ‘Big Pharma’, medical device and biotech companies, and major full-service CROs to offer a first-class recruitment service. www.hydrogengroup.com

5 SGS SGS is a leading life science CRO providing clinical research and bioanalytical testing. Delivering solutions in Europe and in the US, SGS offers clinical trial (Phase I to IV) services encompassing clinical project management and monitoring, data management, biostatistics, PK/PD Modeling & simulation and regulatory & medical affairs consultancy. www.sgs.com/CRO

8 ARISGLOBAL ArisGlobal is the leading provider of integrated solutions for pharmacovigilance & safety, regulatory affairs, clinical development and quality and compliance in medical communications. Life science companies use ArisGlobal’s solutions to build and maintain the trust they need with their customers, medical practitioners and regulatory bodies around the world. www.arisglobal.com

EXHIBITOR PROFILES



17 HAYS LIFE SCIENCES Fast Acting Solutions As the number one Pharma recruiter in Europe (SIA, 2015), with over 239 offices in 33 countries, whether it’s finding a Regulatory Affairs Manager in Amsterdam or sourcing a team of Regulatory Affairs professionals in the UK, we can help you. www.hays.co.uk/life-sciences

11 EXTEDO EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). We focus on optimizing our clients’ eRegulatory business processes and are the only vendor that provides solutions covering the entire regulatory landscape. Today, EXTEDO enables about 35 regulatory authorities and over 700 maintained customers across 60 countries to deliver Effortless Compliance™ www.extedo.com

14 TARIUS Tarius® Web Portals provide easy answers to your global FAQ’s! Subscribing to Tarius enables online access to updated regulatory information on Human Drugs, Biologics, Medical Devices, IVDs across 125 countries. Excel-tables enable quick comparison across countries. Experts’ summaries describe national regulatory procedures. Comprehensive compilations of local regulations ensure compliance. www.tarius.com

19 XENDO Xendo is a leading consultancy in the fields of (bio-)pharmaceutical products, medical devices, and healthcare. We provide Regulatory Affairs Services varying from strategic advice to writing and submission of dossiers, a full range of pharmacovigilance (PV) services, and support in your design and quality processes. Our mission is to provide optimal solutions for our customers. www.xendo.com

13 PRODUCTLIFE GROUP ProductLife Group specialises in helping international life sciences organisations more effectively get their products and therapies to market by providing those clients with functional support across all of the regulated stages of the product life cycle—from development to launch, to postmarketing. www.productlifegroup.com

16 VCLS VCLS supports life science companies throughout product development, and engages in communication with regulators and payers. We partner with Biotech, Pharma and Medtech manufacturers to develop, register and launch innovative products in North American and European markets. www.voisinconsulting.com

18 VEEVA SYSTEMS Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 450 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit www.veeva.com/eu

12 REGULATORY PROFESSIONALS Regulatory Professionals, part of the Clinical Professionals Group, is Europe’s leading independent life science staffing business. We are dedicated to Staffing Regulatory experts in the Pharmaceutical, Biotechnology, Devices and CRO industries throughout Europe. Regulatory Professionals also cover ‘Contractors’ (either freelance or permanent through Regulatory Professionals), ‘Permanent Contingency’ and ‘Search and Selection’ recruitment. www.regulatoryprofessionals.com

15 LORENZ LORENZ Life Sciences Group has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ’s solutions are geared specifically for submission assembly, review, publishing, validation and management. LORENZ docuBridge® is the most used eCTD submission management system for U.S., European and Japanese formats and is popular with regulatory agencies and industry alike. www.lorenz.cc

EXHIBITOR PROFILES

FOYER EXHIBITORS

F O U R P I L L A R S C O A C H I N G

F O U R


TOPRA Annual Symposium 2017

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