2018 Programmes

The 2018 Annual Symposium programmes are taking shape. The latest programmes for the Human Medicines, Medical Devices/IVDs, Veterinary Medicines, Professional Competencies and SME sessions below.

Monday, 1 October

11.30 - 12.40
Registration, exhibition and refreshments

Welcome to 2018 Symposium
- Lynda Wight - Executive Director, TOPRA
- Catarina Andersson Forsman - Director General, Medical Products Agency (MPA), Sweden

Opening Lecture

Tomas Salmonson, Chair of the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) 

13.20 - 14.50: Session 1

HMA/EMA Strategy and Work Plan

For the first time the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) adopted a single common strategy for the European medicines regulatory network. The strategy outlines common challenges and opportunities and sets out joint key priorities and a high level road map. On the basis of the strategy, HMA and EMA developed a multi-annual work plan (MAWP). This session will give representatives from HMA and EMA to update attendees on achievements and next steps, and discuss priorities to 2020 and beyond.

Speakers and panelists:
Thomas Senderovitz - Director General, Danish Medicines Agency (DKMA), Denmark and Chair of Heads of Medicines Agencies Management Group
Guido Rasi - Executive Director, European Medicines Agency
David Jefferys - Senior Vice President, Eisai, UK
Juan Garcia Burgos - Head of Public Engagement Department, Stakeholders and Communication Division, European Medicines Agency

15.15 - 16.45: Session 2

International Collaboration

This session will provide an update on international cooperation, information sharing and regulatory activities and initiatives from an ICMRA, WHO and EMA perspective. The focus will be on innovation, a global culture of patient safety, and evolving needs and challenges.

- Jonathan Mogford – Policy Director, MHRA, UK
- Marie Lindquist - Director, Uppsala Monitoring Centre, Sweden
- other speakers to be announced

17.15 - 18.45: Session 3

(This is a joint session with the Medical Devices/IVDs Symposium)

The impact of the UK’s decision to leave the EU continues to have significant ramifications for the pharmaceutical and medical devices industry as well as the EMA, the National Competent Authorities and the Regulatory Network. The UK have made it clear that continued close cooperation in the regulation of medical products is the desired outcome, but negotiations continue between the European Commission and the UK government and the final impact on the healthcare industries is still to be clarified. In the meantime, the EMA prepare to relocate to Amsterdam, which in itself will have a major impact on all stakeholders. This session will consider preparations being made by the EMA and all European Agencies to ensure the continued functioning of the network. Preparations required by the Pharmaceutical and Medical Device Industries will also be discussed. 

- David Jefferys, Senior Vice-President, Eisai, UK
- Marie-
Hélène Pinheiro - Industry Stakeholder Liaison, Corporate Stakeholders Department, Stakeholders and Communication Division, EMA
- Marie Gårdmark - Director of Licensing, Medical Products Agency, Sweden
- Alan Morrison - Vice-President, International Regulatory Affairs, MSD and Chair, EFPIA Brexit Taskforce
- Maurizio Suppo - Co-owner and Principal Consultant, QUARAD
- other speakers to be announced

Tuesday, 2 October

9.00 - 10.30: Session 4

Medicinal Products with Integral Medical Devices – Bringing Two Worlds Together
(This is a joint session with the Medical Devices/IVDs Symposium)

Each year we are seeing progressively more drug-device combinations, often associated with self-administration to treat chronic diseases. Such combinations can be pre-filled, integrated, single-use solutions for patient/user convenience. These non-CE marked Medicinal Product configurations are subject of much industry and regulator debate, as interpretation of the applicable regulations, standards and guidelines is needed. The Medical Device Regulation (EU) 2017/745 will amend the Medicinal Product Directive (2001/83/EC) via Article 117, and as of 2020 place greater focus on the safety, performance and usability of a delivery device constituent. A Notified Body opinion on integral device constituents will be required in many cases, raising questions and concerns across industry. In this session we aim to share some different views from both industry and regulators on the approaches to approval of such products.

- Armin Ritzhaupt - Regulatory Affairs, European Medicines Agency
- Beat Steffen - Founder and CEO at Confinis AG
- Stephen Dew - Associate Director Regulatory Affairs CMC Medical Devices & Combination Products at Biogen Idec
- Other speakers to be announced

11.00 - 12.30: Session 5

Developing Cooperation at the Interface Between Medicinal Products and Medical Devices 

(This is a joint session with the Medical Devices/IVD Symposium)

In recognition of the increasingly blurred distinction between medicinal products and medical devices, the HMA and Competent Authorities for Medical Devices (CAMD) are developing further cooperation to address the challenges of merging regulations. A diverse range of products are being considered, from over-the-counter substance-based medical devices to combination products, off-label use of medicines with CE marked devices, In Vitro- and Companion- diagnostics and combined ATMPs. In this session, we will hear an update on progress of this cooperation initiative at both operational and strategic level and the challenges of classification and working at the drug-device interface from regulator and industry perspectives.

- Maud Perrudin - Deputy Director, Association of the European Self-Medication Industry (AESGP), Belgium
- Ilona Reischl - Vice-chair, CAT, and Head of Clinical Trials for Medicines, BASG - Federal Office for Safety in Health Care, Austria
- Niall MacAleenan - Deputy Director and Head of Medical Devices Department at Health Products Regulatory Authority (HPRA)
- other speakers to be announced 

14.00 - 15.30: Session 6

HTA and Market Access

Regulatory Approval alone does not give patients access to new innovative medicines. In the era of increasing cost pressures and a changing healthcare sector, the pharmaceuticals industry needs to encompass and apply not only the principles for safety and efficacy evaluations, but also cost effectiveness and value-based indicators in order to ensure market access of new medicines. Are we getting out of control with regards to price? To which extent can the new HTA regulation provide progress in giving patients access to new medicines? This session will consider different aspects and elements of market access strategies and will be looking into a case study from recent example on interaction and alignment with HTA bodies.

Christopher Hoyle - Director, Health Economics and Payer Analytics, AstraZeneca
- Niklas Hedberg, Unit Chief, TLV  - The Dental and Pharmaceutical Benefits Agency, Sweden
- Francois Meyer, Advisor to the President, International Affairs, Haute Autorité de Santé
, France

16.00 - 17.30: Session 7

EU Telematics and SPOR Data: An Opportunity for Regulatory Optimisation for Human and Veterinary Medicinal Products

This session will focus on cross-functional initiatives for improving the efficiency both from a regulatory and business perspective. In the European regulatory network, changes are foreseen in the regulatory operation through collaboration between telematics, regulatory and scientific groups as well as industry representatives. These initiatives are mostly regulatory procedure changes utilising information technology to enable the delivery of legal and business requirements. This session will give a better insight and understanding of SPOR, provide a status update as well provide an opportunity for discussion.

Speakers and panelists:
Karin Gröndahl – Business Development Manager, MPA, Sweden
Stan van Belkum - Deputy Director, Medicines Evaluation Board, The Netherlands 
- Jeffrey Martin, Co-chair, SPOR Taskforce, and Enterprise Architect, MPA, Sweden
Remco Munnik - Regulatory Information Director and Business Development Manager at Asphalion
Georg Neuwirther - Head of IT, AGES, Austria 
- Laetitia Le Letty, CMDv Chair, ANSES, France

Wednesday, 3 October

9.00 - 10.30: Session 8

The Regulatory Role in Early Access Schemes to Patients

Patient access to medicines remains a fundamental objective to all the stakeholders involved in medicines regulation. Even though many challenges, such as affordability and pricing of new medicines, remain extremely cross-disciplinary, early access schemes (EAS) remain an area where the regulatory professional plays a critical role in ensuring that early patient access is balanced with benefits and risks of innovation. But what are early access schemes and how do they link to regulatory strategies in Europe? This session will shed light on the current mapping of available early access schemes in EU member states and how these play an important part in the voyage between medicines regulation and patient access.

- Marie-Hélène Pinheiro - Industry Stakeholder Liaison, Corporate Stakeholders Department, Stakeholders and Communication Division, EMA
Robert A. Johnstone - Board Member at International Alliance of Patients Organisations, UK
- Bharti Navsariwala - Senior Director, EU Regulatory Affairs – Oncology, Takeda

11.15 - 12.45: Session 9

Advanced Therapy Medicinal Products (ATMPs): Cell and Gene Therapies, the Future?

After 10 years with the ATMP Regulation, there are only a handful of approved products on the market. With a great number of products in the pipeline there are still challenges to overcome, especially for SMEs and academia. In this session we will hear about plans and activities to facilitate for developers of ATMPs and about the experience gained by a Swedish SME.

Speakers and panelists:
- Lisbeth Barkholt - Clinical Assessor, Medical Products Agency Sweden; and EMA CAT member
- Margareth Jorvid - Head of Regulatory Affairs and QA, Immunicum, Sweden
- Ilona Reischl - Vice-chair CAT and Head of Clinical Trials for Medicines and Dedical devices, AGES, Austria
- Rocio Salvador Rolan - Policy Officer, Unit B5, DG Santé, European Commission
Marie-Hélène Pinheiro - Industry Stakeholder Liaison, Corporate Stakeholders Department, Stakeholders and Communication Division, EMA

Parallel Sessions

Tuesday, 2 October

11.00 - 12.30

Chemistry Manufacturing and Controls (CMC) 

This session is in two parts:
- Part 1 will focus on the challenging aspects facting CMC in the area of paediatric medicines/age appropriate formulations that permit accurate dosing and enhance adherence, and are an important part of any paediatric regulatory programme. A global strategy for development and filing age-appropriate paediatric information is a key component of the regulatory strategy.
- Part 2 will examine the evolving regulatory reforms in China and the potential for impact to CMC strategies throughout the product lifecycle.

- Cheryl English - Director, Global CMC, Pfizer
- Karen Davis - Regulatory CMC Associate, AstraZeneca

14.00 - 15.30

Enhancing Product Information and the Opportunity to Develop an Electronic Approach
In the Pharmacovigilance Directive 2010/84/EC, Article 59, the European Commission was required to present to the European Parliament and the Council an assessment report on current shortcomings in the summary of product characteristics (SmPC) and the package leaflet (PL) and how they could be improved in order to better meet the needs of patients and healthcare professionals. In March 2017 the European Commission released the final assessment report including areas to be improved within current legislation and in November 2018 the EMA issued their Action Plan in response to the report including a key proposal to have a multistakeholder workshop in Q3 2018 to develop principles for the development of electronic provision of product information. This session will provide an opportunity to discuss the recommendations made in the report and how best they can be implemented, particularly with regard to the development of an electronic approach to enhance the patient’s understanding of their medicine and have rapid access to up to date information.

Sharon Gorman - Director, EU Regulatory Policy, Pfizer
Isabella Sanderfelt - Head of Regulatory Affairs, Nordic and Baltic Region, and Head of Regulatory Affairs, Sweden, Pfizer
Fabio D'Atri - Policy Officer, Unit B4 DG Santé, European Commission
- Juan García Burgos - Head of Public Engagement, European Medicines Agency (EMA)
Christer Olsson - Head of Regulatory Affairs Nordics and Baltics, Sanofi, Sweden
Robert A. Johnstone - Board Member at International Alliance of Patients Organisations, UK

Wednesday, 3 October

9.15 - 10.45

Introduction to Advanced Therapy Medicinal Products (ATMPs)

ATMPs are defined as gene therapies, somatic cell therapies and tissue engineered products. Since the introduction of the ATMP regulation (EC) 1394/2007 there are a minimal number of ATMPs that are authorised for use. There is a recognition of the specific needs of innovators developing these products and support has been provided with respect to fees and access to scientific advice. In this session we plan to provide an introduction to ATMPs and their associated regulations as background to session 9 on ATMPs.  We will use examples of products that are authorised (where available) to demonstrate the types of ATMPs: cell based therapies CAR-T: gene therapies and more; opportunities for interaction with EMA and some of the considerations during development and post authorisation that are specific to ATMPs.

- Kathryn Parsley – Associate Director, Boyd Consultants (Boyds), UK
- Other speakers to be announced

11.15 - 12.45

Clinical Trials Regulation
The implementation date for the EU clinical trial portal is now expected in 2020. After a transitional period of one year it will be mandatory to use the portal and database for all new clinical trials in the EU, and after three years all trials must be transferred. This session will share the hands-on insights of testers from industry, Agencies and Ethics Committees on the portal and database functionality, as well as experience gathered by the Swedish MPA and Ethics Committees with their national CTR pilot. We will discuss transition guidance documents and the challenges of practical implementation of the legislation. 

Christopher Price - Manager, Global Regulatory Affairs, Merck, Germany
Gunilla Andrew-Nielsen - Head of Department of Clinical Trials and Special Permissions, MPA, Sweden
- Other speakers to be announced

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