symposium brochure

Official carrier of the 9th TOPRA Annual Symposium 2012

TOPRA – Provides: Education, Information, Training, Networking, Support

PhARmAcEuTIcAl SymPOSIum 1–3 October 2012 Human Medicines

mEdIcAl dEvIcES SymPOSIum 1–2 October 2012 (2 October only – Stillorgan Park Hotel) Medical Device Regulation in Europe: Now and the Future

vETERINARy mEdIcINES SymPOSIum 2–3 October 2012 (Stillorgan Park Hotel) Legislation, Innovation and Rationalisation

SmE dAy 1 October 2012 Regulatory challenges for and support to SME companies

1–3 October 2012

university college dublin,

Ireland

Working in cooperation

with the Irish medicines Board

Brochure contents 4–9 Pharmaceutical programme 10–11 Medical Devices programme 12–13 Exhibitor profiles 14–15 Conference floorplan 16 Symposium 2013

Dear colleagueOn behalf of TOPRA and its Working Party for the 9th Annual Symposium, it is my pleasure to welcome all of you to Dublin and of course to the University College Dublin.

I would like to thank the Irish Medicines Board (IMB) for their tremendous support for this year’s Symposium which combines the hot topics in regulatory science with the flavour and friendly hospitality of the Emerald Isle.

As you will see below the Programme Committee has been drawn from IMB, the EMA, other national competent authorities and industry who have brought together a mix of interesting topics that all Regulatory Affairs Professionals should be following or actively involved in their day to day jobs.

We have sessions on procedures that are mature such as scientific advice and centralised procedure which will update you on all the new initiatives in these. We are also going to debate the new clinical trial proposal as well as looking at the implementation of the EU pharmacovigilance legislation a few months after its introduction. In addition we are going to have a very interesting session on debating the new EU medical device legislation which will be joined by our colleagues attending the Medical Device Symposium. Therefore there is a lot happening in the EU Regulatory field today and this is a good chance for you to fully update yourself and be actively involved in the discussions.

Alongside these specific regulatory affairs topics we will have be looking at how initiatives on falsified medicines and how these are progressing to eradicate this dangerous international crime. We will also have a session on OTC medicines looking at the latest regulatory trends of moving medicines from prescription to OTC medicines as patents run out on some of the major medicines in the EU. In the availability of medicines we will be debate the lack of access of medicines to patients in the EU and how this can be improved. Finally delivering patient information is very important and we will be looking at the current legislation and how this can be improved to give the patient the best information possible on their medicines. You will also have a chance to hear the IMB give an overview of their current role and activities locally and in the EU and some of the challenges for this vibrant Regulatory agency.

This year we have also introduced parallel sessions on other topics of local and operational interest that are run by the IMB and exhibitors and delegates at the Symposium are free to attend them as well. Look out for these as alternative choices to the main sessions where the IMB will cover Compliance with Marketing Authorisations , Developments in Pharmaceutical Quality, Common European Submission Platform (CESP) and Herbal Medicines Regulatory Update.

On the networking side we have over 20 exhibitors attending the Symposium exhibiting their tailored regulatory services of interest and on the first evening, we are running a networking drinks reception and a number of interesting stalls displaying local produce as well entertainment that showcases the flavor of Ireland. On the second night after an introduction by a Irish Ministry speaker we have a networking buffet dinner to ensure you can meet with all your colleagues, this will give you an opportunity to meet, discuss and engage with likeminded colleagues on subjects of mutual interest.

So it is my pleasure to Chair this year’s Symposium and would like to thank the IMB and everyone involved in the working party and the TOPRA Office for their fantastic support in bringing together this year’s exciting Symposium and encourage you all to be actively involved in the networking and engaging fully in the discussions during the sessions.

Craig McCarthy

2 TOPRA – The Organisation for Professionals in Regulatory Affairs

Brochure contents 4–9 Pharmaceutical programme 10–11 Medical Devices programme 12–13 Exhibitor profiles 14–15 Conference floorplan 16 Symposium 2013

As upcoming President of TOPRA, it is my great pleasure to welcome you to the 9th TOPRA Annual Symposium in dublin. I would like to sincerely thank the Irish medicines Board (ImB) and craig mccarty and the TOPRA Symposium Working Party for jointly organising this year’s Symposium. As a result of their joint hard work, this symposium will be a truly exciting event. The program includes highly-respected speakers from European commission, regulatory agencies and industry and covers most relevant hot topics in all aspects of the healthcare regulatory sector. In the stimulating environment of the university college of dublin, there will be ample opportunity for networking, interaction and debate.

With the annual Symposium in Dublin, my Presidency of TOPRA also comes closer. My overall objective will be to ensure that TOPRA continues to excel in supporting the healthcare regulatory profession. If you are interested to hear more about our plans for the upcoming year, you are most welcome to join us at the “TOPRA Annual Review” on Tuesday afternoon at the Symposium.

I wish you all a great Symposium. Enjoy your time in Dublin and I am looking forward to meeting as many of you as possible during the events.

Patrizia Nestby

On behalf of the Irish medicines Board I would like to welcome all delegates to dublin for what I am confident will be a very informative and rewarding event. I also wish to welcome all our speakers and respective chairpersons and thank them in advance for their contributions over the coming days. my colleagues and I are delighted to have the opportunity to co-host the 2012 Symposium which in its 9th year is now firmly established as one of the principal regulatory events in Europe.

From an Irish Medicines Board perspective, the wide-ranging agenda of the Symposium is particularly welcome in that it affords us the opportunity to meet and discuss regulatory developments and updates with professionals from across the key sectors of human and veterinary medicines, and medical devices. There is much to discuss and review across each of these product areas and I am certain that the range of expert contributors and the broad base of the delegates attending will ensure lively and enlightening debate.

We are also very pleased to lend our support to the dedicated SME day which is especially important in assisting life sciences companies with high growth potential to identify and deal with the regulatory challenges they may face.

Finally, I wish to acknowledge the insights and considerable efforts of all those involved in organising this significant event and all those who guided the development of an excellent program which includes contributors from across the European regulatory spectrum.

I look forward to meeting and chatting with you over the course of the next few days.

Pat O’Mahony, Chief Executive, Irish Medicines Board

Working PartyCraig McCarthy, CAMPHARM, France (chair)

Ann O’Connor, Irish Medicines Board

Anthony Humphreys, European Medicines Agency

Maria João Morais, Infarmed, Portugal

Angelika Joos, Merck Sharp & Dohme (Europe) Inc, Belgium

Margareth Jorvid, LSM Group, Sweden (co-chair)

Brenton E James, EU Consultant

Eamonn McGowran, Newport Pharma, Ireland (TOPRA-in Ireland)

Helene Thybo, Leo Pharma, Denmark

Christelle Anquez-Traxler, AESGP, Belgium

Alan Hunter, Consultant, UK

With input from parallel Symposia chairs:

Veterinary Medicines

Ray Harding, Independent Consultant, UK

Medical Devices

Margareth Jorvid, LSM Group, Sweden

Anne Tobin, Irish Medicines Board

And support from TOPRA SPIN, Regional and TOPRA-IN groups

www.topra.org 3

The 9th TOPRA Annual Symposium 2012 cONfERENcE PROgRAmmE

MOnDAy 1 OcTObeR 201212:00 Registration and Exhibition

13.00 Welcome to 2012 Symposium

Lynda Wight, Executive Director, TOPRA

Craig McCarthy, Chair of Symposium working party

Pat O’Mahony, Irish Medicines Board (IMB) Chief Executive

SESSION 1Scientific Advice: an Important Strategic Activity for all companies Involved in Drug Development especially SMesLeader: Craig McCarthy, Managing Director, CAMPHARM, France

This session will deal with the new initiatives in scientific advice both Nationally (decentralised) and Centralised (CHMP). The Agency speakers will give their individual views on the advantages of scientific advice as well as outlining the new initiatives introduced into the procedure such as joint advice with HTAs, qualification advice and opinions. The industry speakers will give some top tips for SMEs in gaining their strategic advice and as well as their experiences as an SME on gaining advice from the centralised or National procedures and the importance of this procedure to their drug development program in the EU. There is also a special guest from the FDA that will give her observations on parallel advice after her sabbatical in the EU.

chairperson

Craig McCarthy, CAMPHARM, France & TOPRA Symposium Chair

13.30 Introduction – Craig McCarthy

13:35 update on National Agency Scientific Advice

David Wright, Head of the Scientific Advice Unit, MHRA, UK

● The advantages of obtaining national scientific advice from the MHRA perspective

● The new initiative with joint scientific advice with NICE

● Some top tips for companies to obtain the best advice from a national procedure

● Statistics of scientific advice at the MHRA

13:55 centralised scientific advice

Sheila Killalea, IMB delegate to the SAWP, IMB, Ireland

● The procedure and advantages of obtaining centralised scientific advice via the EMA

● The new initiatives with scientific advice including joint advice with HTAs and qualification advice/opinion

● Some top tips for companies to obtain the best advice from the centralised procedure

● Statistics of scientific advice at the EMA

14:15 Top tips on a strategic approach to obtaining scientific advice

Ronan Donelan, Head of Regulatory Affairs EMEA & ANZ, Quintiles, Ireland

● Top tips on regulatory strategy for SMEs

● Pitfalls of going through the process

14:25 Reflections from an SmE company to National and chmP scientific advice

Richard Jones, Clinical R&D Manager, Cosmo Pharmaceuticals

● Presenting a first time experience of an SME of going through both national and CHMP scientific advice processes and how it helped their development strategy

● Reflections on how things could have been improved from both sides

14.35 Parallel EmA/fdA scientific advice

Janice M. Soreth, Deputy Director, FDA Europe Office, Liaison to EMA, USA

● The procedure

● Experience so far and advice to users

14.45 Questions with this sessions’s speakers

The speakers will take questions from the floor – this is your opportunity to explore the topic more fully.

15.00 Break


programmeMONday 1 OctObEr 2012

SESSION 2clinical TrialsLeader: Margareth Jorvid, Senior consultant, Methra Uppsala AB/LSM Group, Sweden

Clinical trials are investigations in humans intended to discover or verify the effects of an investigational medicinal product. Requirements for the conduct of clinical trials in the EU are provided in the Clinical Trials Directive 2001/20 EC. Since the implementation of this directive the interpretation and practical use have differed throughout the European member states. The European Commission is planning to put forward, in 2012 a legislative proposal to revise the Clinical Trials Directive. The proposal, its impact and how it influences performing clinical trials in Europe will be discussed in this session.

chairperson

Margareth Jorvid, Senior consultant, Methra Uppsala AB/LSM Group, Sweden

15:45 Introduction

15:50 The Eu commission legislative proposal to revise the clinical Trials directive 2001/20/Ec.

Stefano Soro, Head of unit D6 Medicinal products – quality, safety and efficacy, DG SANCO, European Commission

● Content of proposal

● Most important changes

● Follow-up from the EU Commission

● Timelines

16:10 The clinical Trials facilitation group (cTfg)

Hartmut Kraft, PEI, Germany and Chair of CTFG

● The work of CTFG

● Sharing scientific assessment of multi-national clinical trials

● Harmonising processes, practices and assessments of clinical trials in EU

● Impact of the EU Commission legislative proposal

16:25 Will the Eu commission Proposal facilitate multi-national clinical trials? – a cRO view

Daphne Smyth, Senior Director Regulatory Affairs EU & Asia-Pacific, ICON Clinical Research, Ireland

● Experience of multi-national clinical trials in EU

● Changes with the EU Commission proposal

● Future of clinical trials in the EU

16:40 Joint EmA/fdA gcP Inspections

Janice M. Soreth, Deputy Director, FDA Europe Office, Liaison to EMA, USA

● Choice of trials/sponsor● Experience so far

16:50 Panel discussion with this session’s speakers


17.15 Break

www.topra.org 5

MONday 1 OctObEr 2012

SESSION 3 new eU Medical Device Legislation

This session will cover an introduction to the new legislation, the key changes and consequences.

chairpersonDavid Jefferys, TOPRA President and Eisai, UK

17:30 Introduction

17:35 The new regulations and other changes for medical device legislation in Europe

Manfred Kohler, European Commission, Directorate General Health and Consumers, Unit Health Technology and Cosmetics (SANCO B 2)

● An introduction to the Revision of the EU Medical Device Directives

● A description of the significant changes proposed in the regulations and consequences of these changes

● Other changes proposed

● An outline of the current status in the revision process and the next steps



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TUeSDAy 2 OcTObeR 2012

SESSION 5centralised ProcedureLeader: Brenton James, EU Consultant

Nearly all new chemical entities are approved via the Centralised Procedure in the European Union, and the Committee for Medicinal Products for Human Use [CHMP] plays the key role in scientific assessment of the applications for Marketing Authorisations. The Committee acts in an important role in resolving issues on applications referred from the Decentralised and Mutual Recognition Procedures. In this session the latest information on the Centralised Procedure will be presented and how applications are reviewed by Rapporteurs.

chairperson

Brenton James, EU Consultant

9:00 Introduction

9:05 The chmP

Jens Heisterberg, Chief Medical Officer at the Danish Health and Medicines Authority, Danish CHMP member

● New Marketing Applications

● Arbitration issues

● Role of Scientific Advisory Groups and Peer Reviewers

● Achievements of CHMP in 2012

9:25 The EmA

Anthony Humphreys, Head of Regulatory, Procedural and Committee Support, European Medicines Agency

● Metrics of Centralised Procedure in 2012 to date

● Activities of ORGAM DG (Organisational Matters Drafting Group)

9:45 The role of a national agency – The ImB

David Lyons, Irish Medicines Board (IMB), CHMP member, Ireland

● Success of Ireland as Rapporteurs

● How the Irish Medicine Board handles assessment of applications and re-examinations



10.30 Break

MONday 1 OctObEr 2012

SESSION 4 The role and activities of the Irish Medicines board

This session will cover an introduction to the IMB, its main roles and activities.

chairperson

David Jefferys, TOPRA President and Eisai, UK

18:25 Introduction

18:30 The role and activities of the Irish medicines Board



The speakers will take questions from the floor – this is your opportunity to explore the topic more fully.Panel includes: Ann O’Connor, Director of Authorisation and Registration, Irish Medicines Board

19:00 Networking drinks reception in the exhibition hall – a Taste of Ireland

20:00 close and free to Explore dublin


programmetuESday 2 OctObEr 2012

SESSION 6Self-careLeader: Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP, Belgium

This session will explore the latest developments on self-care in Europe including the recent Commission initiatives on availability and access to non-prescription medicines. The session will paint a broad view of Centralised switches and via MRP-DCP, taking into account the new role of the CMDh and the CMDh Best Practice Guide on self-medication. The reclassification strategy and process will be presented together with tips and advice for companies. A couple of months after the implementation of the new pharmacovigilance legislation, the session will ponder on whether the expected benefits of the legislation have been met in terms of reduction of duplications for both regulatory authorities and companies, savings, increased risk based and proportionate approach which are particular relevant for well-established non-prescription medicines and the many SMEs which constitute the self-care sector sector. Speakers from the IMB, EMA and industry will provide their views.

chairperson

Hubertus Cranz, Director General, AESGP

11:15 Introduction

11:20 EmA viewpoint

Zaide Frias, EMA

● Switch at central level● New legislations (pharmacovigilance legislation and falsified

medicines) and central developments – relevance for non-prescription medicines

● EMA benefit-risk initiative

11:40 Industry viewpoint

Glen Carpenter, Vice President, Regulatory Affairs - EMEA Johnson & Johnson, UK

● Switch/reclassification strategy● Opportunities and challenges when switching● Current switch environment including Commission’s initiatives● Impact of the new legislation pieces (pharmacovigilance,

falsified medicines, variations, etc.) on a self-care company: more opportunities or challenges?

12:00 ImB viewpoint

Olive Smyth, Irish Medicines Board (IMB), Ireland

● Reclassification process in Ireland – how does it work?● New reclassification initiatives



12.45 Lunch

tuESday 2 OctObEr 2012

SESSION 7Availability of medicines – how to solve the challengesLeaders: Ann O’Connor, Director of Authorisation and Registration IMB, Ireland and Helene Thybo, Corporate Regulatory Intelligence Specialist Regulatory Affairs and Safety, Leo Pharma, Denmark

When products are either not applied for a marketing authorisation in a member state, not marketed despite a valid marketing authorisation or the marketing is discontinued in a member state, patients are losing the battle of availability of medicines. From the surface the key issue is public health and the equal access to medicines across Europe. However, all parties involved (regulators, industry, patients, physicians etc) are well aware of the complexity of the matter. The same complexity being one of the reasons why this problem is not easily solved. This session will focus on how to solve some of the challenges in the efforts of making medicines equally available to patients across Europe.

chairpersons

Ann O’Connor, Director of Authorisation and Registration IMB, Ireland and Helene Thybo, Corporate Regulatory Intelligence Specialist Regulatory Affairs and Safety, Leo Pharma, Denmark

14:00 Introduction

14:05 Availability of medicines - A Regulator Perspective

Kristin Raudsepp, Director General Ravimiamet (Estonian agency), Estonia

● Challenges and current problems● Progress so far● Possible solutions

14:25 Industry challenges and ideas to improve the availability of medicines

Pfizer speaker TBA

● Setting the scene from industry perspective● Challenges faced● How industry can actively contribute to improving the

availability of medicines

14:45 Initiatives by the European commission

Peter Bachmann, Chair of CMD(h,)Head of Unit ‘CMDh’, Department of European and International Affairs, Federal Institute for Drugs and Medical Devices (BfArM)

● View on availability of medicines



15.30 Break

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SESSION 9Falsified medicinesLeader: Maria João Morais, Infarmed, Portugal

The falsification of medicines and healthcare products is increasing and represents a serious risk to public health across the world, calling for more regulation and global partnerships to combat this phenomenon. The EU has recently adopted new rules applying to medicinal products which will be applicable from 2 January 2013. The new directive imposes tighter manufacturing and distribution rules, safety features, new rules for active pharmaceutical ingredients, controlling exports and online sales. The directive also calls for international partnerships to assist authorities in developing effective strategies to fight falsified medicines thus promoting the implementation of international agreements such as the Council of Europe MEDICRIME Convention and the EU Heads of Medicines Agencies Strategy to 2015.

This session will look at these issues along with the outcome of the recent public consultations on safety features and active substances manufacturing requirements. We will also hear about stakeholders’ expectations regarding the implementation of the new rules against falsified medicines and Infarmed’s role in developing collaborative partnerships to fight against counterfeit medicines in third countries.

chairpersons

Maria João Morais, Infarmed, Portugal

John Lynch, Irish Medicines Board

16:35 Introduction

16:40 The falsified medicines directive

John Lynch, Director of Compliance, Irish Medicines Board

● The falsified medicines directive● Future steps

17:00 falsified medicines and the Public health Risk

David Shore, Pfizer Ireland

● TBA

17:20 The Role of European authorities in the fight against falsified medicines in third countries

Helder Mota Filipe, Infarmed, Portugal

● International collaborative agreements and strategies

WeDneSDAy 3 OcTObeR 2012

SESSION 10Patient information in 2020Leader: Angelika Joos, Head Regulatory Policy EU & Most of World, MSD (Europe) Inc, Belgium

Many stakeholders have raised concerns with the usefulness of the current static patient information which has been nearly unchanged for several years. The “information to patients” legal proposal is slowly moving through the EU legislation-making process and will not be adopted in the near future. However, the new Pharmacovigilance Legislation is tasking the European Commission to provide a report on the current product information and its usefulness to stakeholders.

This session will cover the expectation of patients related to information on medicines in todays’ environment. It will analyse the feedback and insights gathered through extensive experience with readability testing over the last decade and display the future vision of the pharmaceutical sector how to make this tool more useful. It aims to identify the additional value of a better content and structure and develop a vision for using this important Medical communication tool in todays’ healthcare context.

chairpersons

Angelika Joos, Head Regulatory Policy EU & Most of World, MSD (Europe) Inc, Belgium

Jan MacDonald, Head, Patient Information Quality, MHRA, UK

8:30 Introduction

8:35 Patient Expectations

Denis Costello, Web Communications Manager, EURODIS (Rare Diseases Europe), Spain

● Is there enough information on medicines? ● Where do patients get information from?● Who do they trust?● How useful is the information for their daily life? ● How important is health literacy?● Which role plays social media & Facebook?


SESSION 8The TOPRA Annual Review

16:05 david Jefferys, Patrizia Nestby and lynda Wight

17:40 view of Patient Representative

Avril Daly, CEO, Fighting Blindness, European Patient Forum, Ireland



18:15 ministerial Address

Dr James Reilly, TD, Minister for Health, Ireland

18:30-21:00

Networking buffet dinner


programme8:50 The package leaflet is not for the benefit of the patient

Ann-Margret Tallberg, MSD, representing LIF, Sweden

● Does the package leaflet meet the patients’ need for information?● How do patients perceive the leaflets provided to them?● What do patients want to have?● How can the leaflets be improved?● How can information be conveyed using newer technologies?

9:05 learnings from academic research and from user testing experience

Theo Raynor, Professor of Pharmacy Practice, School of Healthcare, University of Leeds and Luto Research, UK

● What does research tell us about what patients want?● What does user testing tell us?● How can we successfully include more benefit information?● Key issues leading up to 2020

9:20 A Regulator’s perspective on the future needs and introduction to the panel discussion

Jan MacDonald, Head, Patient Information Quality, MHRA, UK



10.00 Break

WEdNESday 3 OctObEr 2012

SESSION 11The new Pharmacovigilance legislation – The experience after implementationLeader: Eamonn McGowran, Regulatory Affairs Manager / QP for Pharmacovigilance Newport Pharmaceuticals Limited, Ireland

The implementation date of July 2012 for the new PV (pharmacovigilance) Legislation has now passed. The new legislation replaces Volume 9A of the rules governing medicinal products; with extensive changes and both agencies and pharmaceutical/biotech companies need to be prepared for those changes that have been introduced. This session will cover the new PV legislation and its impact on both agencies and companies. The Agency speakers will give their individual views on experiences to date. The industry speakers will give their views on the impact the new legislations is making on business systems and steps to be taken to ensure compliance with legislative requirements

chairperson

Joan Gilvarry, IMB, Ireland

10:45 Introduction

www.topra.org 9

10:50 The new Pv legislation - The National Authority Experience to date

Michael Foy, MHRA, UK

● Background● Implementation so far – can the aim of the new PV legislation

be met?● Future issues

11:10 The impact of the new Pv legislation on industry

Deirdre McCarthy, Director, Customer Delivery Europe, Lifecycle Safety & Infrastructure Management, Quintiles, Dublin, Ireland

● Rationale for the changes● Overview of the new PV requirements from a company perspective

11:30 Tips for a successful Pv inspection and implications of the new Pv legislation for future inspections

Sinead Curran, GCP/Pharmacovigilance Inspector, Irish Medicines Board, Ireland

● Overview of IMBs national pharmacovigilance inspection program, including the inspection process and examples of common deficiencies

● A review of the impact of the new pharmacovigilance legislation on the inspection process



12.15 closing remarks by ImB

12.20 close of Symposium by TOPRA President

12.25 End of Symposium

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Medical Devices Symposium 2012 Programme



SeSSIOn 2

The role and activities of the Irish Medicines board

This session will cover an introduction to the IMB, its main roles and activities.

chairperson

David Jefferys, TOPRA President and Eisai, UK

18:25 Introduction

18:30 The role and activities of the Irish medicines Board


● A brief description of the overall responsibilities of IMB and its staffing and structures

● A more detailed description of IMB Medical Devices activities and● The IMB’s practical responses to the Commissioner Dalli Action Plan.

18:50 Panel discussion


Panel includes: Ann O’Connor, Director of Authorisation and Registration, Irish Medicines Board

MOnDAy 1 OcTObeR 2012 (taking place at UCD)

16:30 Registration and Exhibition

SeSSIOn 1new eU Medical Device Legislation

This session will cover the Revision of the EU Medical Device Directives. The aim of the session is to give an introduction to the future regulatory framework, outline the key changes proposed in the regulations and consequences of these changes. An outline of where we are currently and the next steps in the revision process will also be given.

chairpersonDavid Jefferys, TOPRA President and Eisai, UK

17:30 Introduction

17:35 The new Regulations and other changes for medical device legislation in Europe

Manfred Kohler, European Commission, Directorate General Health and Consumers, Unit Health Technology and Cosmetics (SANCO B 2)

● An introduction to the Revision of the EU Medical Device Directives ● A description of the significant changes proposed in the

regulations and consequences of these changes ● Other changes proposed● An outline of the current status in the revision process and the

next steps.



TUeSDAy 2 OcTObeR 2012 (taking place at Stillorgan Park Hotel)

08:45 Registration and Exhibition

09:00 Welcome and Introduction to medical device Symposium:Margareth Jorvid, co-chair of TOPRA Annual Symposium

SeSSIOn 3The Medical Device Regulatory System and the impact of the new Legislation

This session will provide an insight into the impact that the new medical devices legislation will have on the various groups who are party to the medical device regulatory system. The proposed regulations will introduce changes in the area of notified bodies, clinical evidence and market surveillance. This session will discuss these topics in more detail.

chairperson Ann O’Connor, Director of Authorisation and Registration, Irish Medicines Board (IMB)

09:05 Introduction

09:10 Notified Bodies and the Impact of the New legislation

Rainer Edelhäuser, ZLG - Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, Chair NBOG, Germany

09:30 clinical Evaluation and clinical Investigation - the Impact of the New legislation

Wolfgang Ecker, Federal Ministry of Health, Chair CIE, Austria

09:50 market Surveillance and the Impact of the New legislation

Reinhard Berger, Institut Inspektionen, Medizinprodukte & Haemovigilanz, AGES, Chair COEN, Austria



Panel includes: Manfred Kohler, European Commission, Directorate General Health and Consumers, Unit Health Technology and Cosmetics (SANCO B 2) and

Niall MacAleenan, Clinical Assessment Manager Irish Medicines Board

10.30 Break


SeSSIOn 4Regulatory Update

This session will be a regulatory update on several areas where recent changes have taken place or are on-going. A key session to become up to date on in-vitro diagnostics, medical device software, UDI, traceability, e-labelling and demarcation of medicines and medical devices.

19:00 Networking drinks reception in the exhibition hall – a flavour of Ireland

20:00 Close and free to explore Dublin

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www.topra.org 11


SeSSIOn 5Vigilance and Risk Management

This session will cover medical device vigilance issues and risk management. The IMB will give an update on vigilance activities from the regulatory point of view, trends, changes going forward, impact of legislative changes. Risk management will then be looked at from a regulatory and industry perspective.

chairperson Niall MacAleenan, Clinical Assessment Manager, Human Products Authorisation and Registration Department, Irish Medicines Board (IMB), Ireland

13:30 Introduction

13:35 The Importance of vigilance – competent Authority view

Anne Tobin, Vigilance and Compliance Manager - Medical DevicesHuman Products Monitoring Department, Irish Medicines Board

● An introduction to the legislative requirement ● IMB – vigilance activity, trends observed● Change proposed in the revision to the medical devices directives● Impact of Commissioner Dalli Joint action plan

13:55 Risk management

Cathal Brennan, Scientific Officer, General Medical devices, Irish Medicines Board

● Legislative requirement for risk management● The medical device lifecycle and risk management● Post market surveillance

14:10 vigilance and Risk management – Industry view

Philippe Auclair, Senior Director, Regulatory Strategy and Advocacy , Abbott Quality and Regulatory EMEA, Abbott Vascular International, Belgium



Panel includes: Andrea Hanson, Product manager – Vigilance and Compliance Section, Irish Medicines Board

14:45 Break


SeSSIOn 6Access to market

This session will cover information on and guidance on taking a medical device from development into the market phase. Speakers will share support available, and experience from working on the European and Worldwide Markets.

chairperson TBA

15:15 Introduction

15:20 Building an internationally competitive medical devices business - The supports from Enterprise Ireland

Brian O’Neill, Manager Lifesciences, Enterprise Ireland

● How to take medical device product to the market ● What support companies can receive

15:40 from Implantable medical device concept to European market

James E. Coleman, Chief Executive Officer, Vasorum Limited, Ireland

● How to take medical device product from concept to the market ● What were the major difficulties● Key regulatory issues

16:00 from Ireland into a Worldwide market – fdA and beyond

John Kilmartin, Senior RA Director, Medtronic, Ireland

● Challenges with global development and global market introduction

● Practical experience of working in the global context



16:45 TOPRA in Ireland

Ronan Donelan, Head of Regulatory Affairs EMEA & ANZ, Quintiles, Ireland

16:50 close of the medical devices symposium

chairperson

Hilde Viroux, Alcon, Belgium

10:45 Introduction

10:50 In-vitro diagnostics – new legislation and other updates

Anne Van Nerom, Coordinator for In-vitro diagnostic Medical Devices, Scientific Institute of Public Health, Belgium

11:10 medical device Software

Neil Ebenezer, Head of New and Emerging Technologies, Devices Division, MHRA, UK

● A introduction to medical device software and the regulatory system● What constitutes medical device software● Guideline on qualification and classification of standalone

software – healthcare setting ● Future activities

11:30 unique device Identifiers, Traceability and E-labelling

Graeme Tunbridge, Head of Medical Devices EU Policy, MHRA, UK

● A introduction to UDI and traceability● Developments at a European level - joint action plan● Developments internationally - IMDRF● E-labelling and the Commission regulation

11:50 demarcation of products as medicines or medical devices

Waldo Weijers, Pharmacist, MEB, the Netherlands

● Regulatory framework for medicines and medical devices● Combination products● Two Worlds? One and the same Patient!



12:30 lunch

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www.hays.co.uk

Merrill Brink International is a leading provider of specialist translation services with tailored solutions for pharmaceutical, biotechnology firms, clinical research organisations (CROs) and regulatory consultants.

Merrill Brink is certified to ISO 9001:2008, ISO 27001:2005 and ISO 13485:2003; and registered to EN 15038:2006 and ISO 14971:2007.

www.merrillbrink.com

EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management. The complete EXTEDOsuite covers: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labeling Management and Document Management.

Today EXTEDO serves more than 700 customers in 57 countries including EMA and more than 25 Regulatory Authorities worldwide.

www.extedo.com

Tarius® Web Portals provide easy answers to your global regulatory FAQ’s.

Subscribing to your company-specific Tarius web portal enables direct access to your selection of Human Drugs, Biologics, Medical Device, IVD regulatory information from 75+ countries. It’s “Google-like”, hassle-free and updated daily. Why not contact us for a free trial?

Contact: Eva l. PetersenEmail: [email protected]

ArisGlobal is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and medical information. Hundreds of life science companies rely on ArisGlobal’s advanced solutions for maintaining regulatory compliance, workflow automation, improving operational efficiency and easily sharing information around the globe.

www.arisglobal.com

Barrington James has 2 dedicated Regulatory Teams spanning the globe, 1 specialising in Drug Development & 1 in Medical Devices. Their 10 year history and extensive network developed over that time has grown their reputation of providing outstanding candidate & client satisfaction and a true consultative approach from their offices in the UK, Europe, Singapore & the USA.

www.barringtonjames.com

Exhibitor to be announced.

exhIbITOR TO be AnnOUnceD

Real Regulatory is a team of proven and committed experts in regulatory affairs, providing consultancy and hands on assistance to the pharmaceutical, medical device and related industries. Our team of professionals have many years experience and a wide range of expertise across the spectrum of regulatory affairs activities.

www.realregulatory.ie

eRegulatory Affairs

Octagon Research Solutions, Limited is the leader in the electronic transformation of clinical R&D. We offer a suite of regulatory, clinical, process and IT solutions to the life sciences industry. Our integrated suite of offerings is built upon deep domain knowledge, cross-functional eSub expertise, a holistic process approach and integrated solutions.

www.octagonresearch.com

LIQUENT provides technology and outsourcing solutions focused around regulatory submission preparation and tasks, dossier planning, eCTD to CTD publishing and registration tracking capabilities. LIQUENT is the premier provider of a scalable, regulatory information management platform and associated regulatory & clinical services that can be leveraged throughout a client organization.

www.liquent.com

The 9th TOPRA Annual Symposium 2012 ExhIBITOR PROfIlES

5 Liquent – US

9 Merrill brink – Ireland

6 Qumas/Pleasetech – UK

10 hays Life Sciences – UK

1 exhibitor TbA 3 Aris Global – Germany

7 Tarius – Denmark

11 Real Regulatory – Ireland

2 The Regulatory Affairs company – UK 4 barington James – UK

8 extedo – Germany

12 Octagon – UK


CTC Clinical Trial Consulting AG is a key provider of flexible resourcing solutions to Pharma/Biotech, Med Devices and CROs. Referred to as the gold standard by our candidates and clients, we have a strong track record of engaging and placing the very best talent in Clinical, pre-Clinical, Safety, and Regulatory/Med Affairs roles.

www.ctcon.ch

Thomson Reuters Life Sciences supports R&D productivity across the Pharma lifecycle with respected and comprehensive intelligence solutions.

Offering unbiased scientific, competitive, regulatory, and generics information, analytics, and expertise for your organization, Thomson Reuters Life Sciences empowers and enables effective, evidence-based decision-making at every stage from discovery to launch and beyond.

www.science.thomson reuters.com/pharma

DWL Ltd. is a specialist translation service provider for the pharmaceutical industry with translation solutions in regulatory affairs and clinical & medical research. Celebrating its 50th year, DWL has grown through a dedication and commitment to quality and service. DWL focuses on languages for traditional and emerging markets.

www.dwlanguages.com

The Key People Regulatory Affairs Team is one of the most accomplished in the UK & Europe. We have successfully recruited for positions from Regulatory Vice President through to Director, Manager and Associate Levels in Core Regulatory Affairs, Clinical/non-Clinical & CMC, Labelling, Operations & Publishing. We cover Pharma, Biotech, Generics and OTC sectors.

www.keypeople.co.uk

Samarind RMS is an innovative regulatory tracking database with integrated xEVMPD, eCTD and EDMS tools. Users in over 100 countries agree that the system is quick to learn and easy to use, with superbly flexible reporting facilities and excellent security.

And Samarind is a great company to work with.

www.samarindrms.com

ProClincial work extensively in recruiting both temporary and permanent Regulatory Affairs professionals within the European Pharmaceutical industry. As an established preferred supplier to some of the world’s most prestigious and pioneering companies, ProClinical can help both candidates and hiring managers to achieve their recruitment goals quickly and cost efficiently.

Trust – Knowledge – Delivery

www.proclinical.co.uk

exhibitors

SEC Pharma support Pharmaceutical, CRO and Biotech organisations throughout Europe, focusing on recruitment across Regulatory Affairs, Clinical Research, Biometrics, Medical Affairs and Pharmacovigilance. Our dedicated Regulatory Affairs team provide a consultative service, catering for the individual needs of every client and advising and preparing candidates in line with the continual changes of the Regulatory Affairs marketplace.

www.secpharma.com

NextDocs is the global leader in providing Microsoft SharePoint-based compliance and quality management solutions to life sciences organizations. It enables businesses in regulated industries to achieve compliance with FDA, EMA and other agencies while automating processes, improving efficiency and dramatically reducing costs.

www.nextdocs.com

Delivering software and regulatory services to more than 240 clients over 20 years, CSC Life Sciences provides innovative business solutions to the complex challenges facing the global life sciences industry. A full suite of Total Business (TBS) Solutions has been developed to address the industry’s business processes.

Visit us at www.csc.com to learn more.

LORENZ is the most established provider of e-regulatory software and services in the world. LORENZ has focused on bringing intuitive, business-driven solutions to the market. As an innovative software engineering company, LORENZ’ solutions foster independence, empowering customers to develop their processes and maintain control of their own intellectual property.

www.lorenz.cc

INFOTEHNA Group is a market leader in the development and delivery of integrated enterprise content management solutions (ECMS) for Life Sciences industry.

INFOTEHNA’s integral by designTM set of solutions myPharmaExpert SuiteTM effectively address industry-specific challenges in the fields of Regulatory Affairs, Quality Assurance & Quality Control, Research & Development and Pharmacovigilance.

www.infotehna.com

emedcareers.com is the online job website for specialists looking for jobs in the development and marketing of medicines and medical equipment. Search and apply for the latest European based jobs in the pharmaceutical, biotechnology and healthcare industries from leading recruiters and employment agencies.

www.emedcareers.com

13 Dora Wirth – UK

17 Key People – UK

21 Samarind RMS – UK

15 emedcareers.com – UK

19 Infotehna – Slovenia

23 Lorenz – UK

14 Proclinical – UK

18 clinical Trial consulting (cTc) – UK

22 Thomson Reuters – US

16 cSc – UK

20 Sec Pharma – UK

24 nextdocs – US

samarindRMSregulatory management software

www.topra.org 13

The 9th TOPRA Annual Symposium 2012 cONfERENcE flOORPlAN


Registration area

Exhibition area

Catering station

■ IMB

■ TOPRA

■ Four Pillars

■ Cran�eld

■ Cogent

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Stand company

The Regulatory Affairs Company

Extedo

ProClinical

SEC Pharma

Barrington James

Hays Life Sciences

CSC

Thomson Reuters

Qumas/Pleasetech

Octagon

CTC

Nextdocs

Exhibitor TBA

Tarius

Dora Wirth

Infotehna

Aris Global

Merrill Brink

emedcareers.com

Samarind RMS

Liquent

Real Regulatory

Key People

Lorenz

Exhibitors

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2

3

4

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6

7

8

9

10

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Symposium 2013Lisbon, Portugal

The 10th TOPRA Annual

TOPRA – The Organisation for Professionals in Regulatory Affairs

October 2013Organized In conjunction with INFARMED – National Authority of Medicines and Health Products, I.P, Portugal

More information, visit www.topra.org/symposium2013

Pharmaceutical Symposium

Medical Devices Symposium

Veterinary Symposium

symposium brochure

Documents

otc medicines

falsified medicines

major medicines

availability of medicines

medical device symposium

eu regulatory field

years symposium

regulatory challenges