2018 Programmes

Thank you for your interest in our 2018 Annual Symposium. The following programme information is subject to change; finalised programmes for each Symposium track will be published closer to the event.

If you would like to be notified when finalised programmes are available, please contact our meetings team.

Opening Lecture

Tomas Salmonson, Chair of the EMA's Committee for Medicinal Products for Human Use (CHMP) 

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 2016–2020 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 the possibility for representatives from HMA and EMA to update on achievement and next steps, and discuss priorities to 2020 and beyond.

Speakers to be announced

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
- other speakers to be announced

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.

- Marie Gårdmark - Director of Licensing, Medical Products Agency, Sweden
- Alan Morrison - Vice-President, International Regulatory Affairs, MSD
- other speakers to be announced

Medicinal Products with Integral Medical Devices: Bringing Two Worlds Together
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.

Speakers to be announced

Developing Cooperation at the Interface Between Medicinal Products and Medical Devices 
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 and Dedical devices, AGES, Austria
- other speakers to be announced 

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
- other speakers to be announced

EU Telematics and SPOR Data: An Opportunity for Regulatory Optimisation
Futher details to come.

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.

Speakers to be announced

Advanced Therapy Medicinal Products (ATMPs): Are 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.

- 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

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

Clinical Trials Regulation
Earlier this year a notice was published in Official EU Journal that the EU clinical trial portal and database are fully functional and therefore the CT Regulation (EU) No 536/2014 will soon become applicable. 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. 

Speakers to be announced

Introduction to 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

Building Professional Competence sessions

A series of interactive sessions over 1 and 2 October to build your professional competence and those of your teams.

Developing Regulatory Skills and Knowledge: Apprenticeships and Competencies
This first evening of the professional development stream will feature an opportunity for young professionals, MSc students and anyone thinking of joining TOPRA's MSc programme to network and ask about the MSc Regulatory Affairs and other postgraduate qualifications.

Managing Teams Through Change
With Brexit, the MDR and IVDR we are in a period of even greater change than usual, this practical workshop is aimed equipping managers with the skills to optimise the leadership of their teams through this period of change.

Certification: Demonstrating Professionalism and Excellence
A look at TOPRA's certified training programmes for teams and the Chartered Scientist certification for individuals.

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