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, Swedish Medical Products Agency (MPA)

TOPRA Annual Lecture 2018

We are happy we got here, but where do we go now?
Speaker: Tomas Salmonson, former Chair of the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), and Senior Scientific Advisor, Swedish MPA

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 for 2016–2020. 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.

Leader: Isabella Sanderfelt – Head of Regulatory Affairs Nordic and Baltic Region, Pfizer, Sweden
Chair: Christer Backman – International and EU coordinator, Swedish Medical Products Agency (MPA)

HMA plans

  • Half way to 2020 – achievements so far
  • Challenges and obstacles
  • Where will we be at the end of 2020?
Speaker: Thomas Senderovitz - Director General, Danish Medicines Agency (DKMA) and Chair of HMA Management Group

EMA plans

  • Half way to 2020 – achievements so far
  • Challenges and obstacles
  • Where will we be at the end of 2020?
Speaker: Guido Rasi - Executive Director, EMA

Panel discussion 

Session speakers, plus:

  • David Jefferys - Senior Vice President, Eisai, UK
  • Catarina Andersson Forsman - Director General, Swedish MPA
14.50  Break 


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 ICDRA perspective. The focus will be on innovation, a global culture of patient safety, and evolving needs and challenges.

Leader and Chair: Carlos Langezaal –  Senior Director, Global Regulatory Affairs, Celgene, US
15:15  Introduction 

The International Coalition of Medicines Regulatory Authorities (ICMRA) address current and emerging human medicine regulatory and safety challenges globally, strategically and in an ongoing, transparent, authoritative and institutional manner

  • Strategic initiatives
  • Information sharing
  • Regulatory science
Speaker: Jonathan Mogford – Policy Director, MHRA, UK

Going further together: Uppsala Monitoring Centre 40 years and WHO Programme for International Drug Monitoring 50 years

  • WHO Programme for International Drug Monitoring
  • A transformed WHO
  • Universal health coverage
Speaker: Marie Lindquist - Director, Uppsala Monitoring Centre, Sweden

International collaborations

  •  Outcomes of the Dublin International Conference of Drug Regulatory Authorities meeting

Speaker: Lorraine Nolan - Chief Executive, Health Products Regulatory Authority, Ireland

16.20  Panel discussion featuring session speakers 
16.45  Break 

SESSION 3  Brexit 
(This is a joint session with the Human Medicines 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. 

Leader: Sharon Gorman – Director, EU Regulatory Policy, Pfizer, UK
Chair: David Jefferys - Senior Vice President, Eisai, UK


  • What is known to date and what is still to be determined
Speaker: David Jefferys – Senior Vice President, Eisai, UK 

Progress and impact of EMA relocation and impact on current and future centralised products
Speaker: Marie-Hélène Pinheiro – Industry Stakeholder Liaison, Corporate Stakeholders Department, Stakeholders & Communication Division, EMA


Impact on the Regulatory Network

  • Impact on MRP/DCP products
  • Impact on the national agencies
Speaker: Marie Gårdmark – Director of Licensing, Swedish MPA

Pharmaceutical industry views and the preparations required by industry
Speaker: Virginia Acha - Executive Director, Regulatory Policy, Regulatory Affairs International, MSD; and member of  EFPIA Brexit and ABPI/BIA Brexit task forces

17.55  Medical device industry views and the impact for the devices industry
Speaker: Maurizio Suppo – Co-owner & Principal Consultant, Qarad 
18.05  Panel discussion
Session speakers, plus additional panellist Jonathan Mogford – Policy Director, MHRA, UK 

18.45 Networking Reception in exhibition hall

Tuesday, 2 October

08.55  Introduction to Day 2

SESSION 4 – Medicinal Products with Integral Medical Devices: Bringing Two Worlds Together
(This is a joint session with the Medical Devices/IVD 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 the 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. 

Leader and Chair: Mark Chipperfield – Corvus Device Ltd, UK

09.00  Introduction  

A regulator’s view – Observations and reflections from reviewing combined products

  • Recent issues and regulator expectations for medical device constituents
  • Update on CHMP guidance development
  • Advice to manufacturers on preparing for Article 117
Speaker: Armin Ritzhaupt - Regulatory Affairs, European Medicines Agency

A consultant view – Observations from supporting industry in gain combined product approvals 

  • Reflections on the approach in Switzerland
  • Bringing together device Clinical Evaluation and drug Clinical Investigation
  • Who reviews what?
Beat Steffen - Founder and CEO at Confinis AG

An industry perspective - Experiences with EU review of integrated products

  • Past difficulties with obtaining ‘voluntary’ opinions to support MAA
  • Anticipated challenges with the Art. 117 requirements
  • Expectations and needs to smooth the future path
Speaker: Stephen Dew - Associate Director, Regulatory Affairs CMC Medical Devices and Combination Products at Biogen Idec
10.05 Panel discussion featuring session speakers
10.30  Break 

SESSION 5 – Developing Cooperation at the Interface Between Medicinal Products and Medical Devices 
(This is a joint session with the Human Medicines Symposium)
In recognition of the increasingly blurred distinction between medicinal products and medical devices, the Heads of Medicines Agencies (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. 

Leader and Chair: Janine Jamieson - JCombinations and IPQ Publications, Sweden

11.00  Introduction 

Cooperation on medical device regulation, combination and borderline products

  • Cooperation between authorities/CAMD/iimplementation roadmap
  • HMA-CAMD cooperation
  • Increasing convergence and cooperation with medicines regulators
Speaker: Niall MacAleenan - Head of Medical Devices Department, Health Products Regulatory Authority (HPRA), Ireland and member of CAMD EG 

Industry perspective on preparations for Rule 21, substance based medical devices

  • Background and debate about MDR Rule 21, substance-based medical devices
  • Changes in classification for currently marketed products: upclassification of Class I devices
  • Consultation procedure with relevant medicines authorities or EMA in the context of the conformity assessment 
  • Regulatory expectations and industry guidance in development
Speaker: Maud Perrudin - Deputy Director, Association of the European Self-Medication Industry (AESGP), Belgium

Classification of therapies incorporating tissues and cells/blood

  • Medicinal products or medical devices – what determines classification?
  • How do clinical trial requirements differ?
  • Experience of combined ATMPs with device components
Speaker: Ilona Reischl - Vice-chair CAT and Head of Clinical Trials for Medicines and Dedical devices, AGES, Austria
12.00  Panel discusssion
Session speakers plus additional panellist Armin Ritzhaupt - Regulatory Affairs, European Medicines Agency 

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.

Leader and Chair: Victoria Eriksson – Regulatory Affairs Team Manager, AstraZeneca, Sweden

14.00 Introduction

EU Commission, new HTA Regulation 2021

  • Highlights and consolidation of key points in the new HTA regulation
  • How far have we come and what will happen next? What are the challenges?
  • Experience from ongoing EUnetHTA assessments and how it can feed into an improved process
Speaker: Flora Giorgio - Head of HTA Sector, European Commission, Unit B4 – Medical Products: Safety, Quality, Innovation

EUnetHTA, FINOSE- A Nordic cooperation for joint assessments and Sweden’s Dental and Pharmaceutical Benefits Agency view on how Real World Evidence can make a difference in HTA decision-making

Speaker: Niklas Hedberg, Unit Chief, TLV  - The Dental and Pharmaceutical Benefits Agency, Sweden, and Chair, EUnetHTA


Parallel consultation for Regulatory and Health Technology Assessment

  • What are the experiences from parallel consultations so far?
  • Challenges and potential enablers for parallel consultations
  • Statistics on completed parallel consultations with EMA
  • Examples of consultations for post-authorisation data collection?
Speaker: Francois Meyer - Advisor to the President, International Affairs, Haute Autorité de Santé (HAS), France


Case study: The reality of real world evidence-based perspective

  • Accelerated development enabled by scientific results
  • The challenge with different requirements by different HTAs across Europe
  • Recommendations for the future
Speaker: Alfred Sackeyfio – Health Economics and Payer Evidence Lead, AstraZeneca, UK

15.05 Panel discussion featuring session speakers
15.30 Break

SESSION 7 – EU Telematics and SPOR Data: An Opportunity for Regulatory Optimisation for Human and Veterinary Medicinal Products
(This is a joint session with the Veterinary Medicines Symposium)

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. 

Leader: Anna Mäkinen Salmi – Head of Regulatory Department, Swedish MPA
Chair: Karin Gröndahl – Business Development Manager, Swedish MPA, Sweden




ROG – Optimisation of Regulatory Affairs and Operations

  • Introduction of the Regulatory Optimisation Group (ROG)
  • Business case – Type IA variations
Speaker: Stan van Belkum – Chair, ROG, and Deputy Director, Medicines Evaluation Board (MEB), The Netherlands


SPOR – How to get ready for the implementation of SPOR and IDMP

  • SPOR implementation roadmap
  • Future implications on the business process for marketing authorisation applications (MAA) for human and veterinary products
  • Harmonisation and validation to generate trust in the data
Speaker: Jeffrey Martin – Co-chair of SPOR Taskforce, Enterprise Architect, Swedish MPA 


CESSP – Integration of the eAF with CESP Portal

  • CESP dataset module to Go Live for new MAAs
  • How to better reuse the data
Speaker: Georg Neuwirther - Head of IT, AGES, Austria; and project leader for CESSP project


Panel discussion 
Session speakers, plus:

  • Remco Munnik - Chair of Telematics Group of Medicines for Europe and Regulatory Information Director, Asphalio
  • Laetitia Le Letty – CMDv Chair, French Agency for Veterinary Medicinal Products (ANSES), France


17.35 TOPRA Annual Review Meeting and Announcement of Poster Competition Winners 
18.15 - 19.15 Networking buffet in exhibition hall 


Wednesday, 3 October

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. 

Leader and Chair: João Duarte, Associate Director, Europe Regulatory Policy and Intelligence, Takeda, UK

09.15  Introduction 

An industry perspective on early patient access as a regulatory objective

  • Industry experience on defining early access to patients in regulatory terms
  • Challenges and opportunities in the EU in pursuing early access opportunities and lessons learned from an R&D perspective
  • Reflections on stakeholder engagement from an industry perspective when developing evidence generation to support early access
Speaker: Bharti Navsariwala - Senior Director, EU Regulatory Affairs – Oncology, Takeda 

How can regulators support early access through R&D and evaluation support?

  • How early is “early” access and how do regulators define trade-off between evidence and marketing authorisation?
  • Available regulatory tools that support development and eventually access
  • How are regulators horizon-scanning and acting on future access challenges?

Speaker: Tomas Salmonson - Chair CHMP, EMA & Scientific Advisor, Swedish Medical Products Agency


Is “early” the new standard? A patient’s view on early access 

  • Thoughts from a patient representative on the importance of early access, both from available schemes and from a conceptual perspective
  • What is (and should be) the patient role in defining early access?
  • Current areas where patient input provides value to early access
Speaker: Robert Johnstone – Chair, Access Matters – Midstream; Board Member, European Forum for Good Clinical Practice (EFGCP), Health Quality Improvement Partnership (HQIP), and International Foundation for Integrated Care (IFIC), UK
10.25  Panel discussion featuring session speakers 
10.45  Break 

SESSION 9 – Advanced Therapy Medicinal Products (ATMPs): Cell and Gene Therapies, the Future?
After 10 years of 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 small and medium-sized enterprises (SMEs) and academia. This session will look at plans and activities to facilitate for developers of ATMPs and about experience gained by a Swedish SME.

Leader and Chair: Vera Franzén - Regulatory Affairs Consultant, Vera Franzén Consulting, Sweden
11.15  Introduction 

European Commission perspective

  • EU initiatives to support the development of ATMPs
Speaker: Rocio Salvador Rolan - Policy Officer, Unit B5, DG Santé, European Commission


CAT perspective

  • CAT activities – daily work and new/revised regulatory guidelines
  • Lessons learned
  • Safety – a risk-based approach, patient follow-up and risk management
Speaker: Lisbeth Barkholt - Clinical Assessor, Medical Products Agency Sweden; and EMA CAT member


An SME regulatory ATMP case study

  • ATMP classification
  • Scientific advice (national, EMA and FDA)
  • EMA ATMP certification
Speaker: Margareth Jorvid - Head of Regulatory Affairs and QA, Immunicum, Sweden

12.20  Panel discussion featuring session speakers plus:
- Ilona Reischl – Federal Office for Safety in Health Care (BASG), Austria 
- Marie-Hélène Pinheiro – Industry Stakeholder Liaison, Corporate Stakeholders Department, Stakeholders and Communication Division, EMA 
12.45  End of Symposium 


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