2019 TOPRA ANNUAL SYMPOSIUM Logo

Programmes

Our list of programme topics and speakers for the 2019 TOPRA Annual Symposium is subject to change as the event approaches. A final programme will be published in September 2019.

30 September

11:30 – 12:30 Registration
12:30 – 12:40  Welcome to the 2019 Symposium
12:40 – 14:10 

HM1: Europe as a centre for regulatory excellence – the journey 
Leader: João Duarte, Associate Director, Regulatory Intelligence, Alexion Pharmaceuticals, France
Chair: Lorraine Nolan, Chief Executive, Health Products Regulatory Authority (HPRA), Ireland

The European regulatory framework is a respected, well established and unique network of regulatory expertise that supports an important public health mission and improves healthcare for hundreds of thousands of citizens. How is it tackling the current challenges and opportunities facing healthcare regulation and what unique features make such a framework fit to spur innovation, advance regulatory science and support patient care? This session will reflect on how European healthcare regulation has evolved and where it is headed, and how it continues to advance regulatory science and public health.

12:40 - Introduction

Speaker: Lorraine Nolan, Chief Executive, Health Products Regulatory Authority (HPRA), Ireland

12:50 - Panel discussion

Speakers:

  • Anthony Humphreys, Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency (EMA), the Netherlands
  • Florian Schmidt, Deputy Head of Unit B5, Directorate General Health and Food Safety (DG Sante) European Commission
  • Pär Tellner, Director, Regulatory, Drug Development and Manufacturing, European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium
  • Greet Musch, General Director DG PRE Authorisation, Federal Agency for Medicines and Health Products (FAMHP), Belgium
14:10 – 14:50 Tea & coffee break
 
For the next session, delegates have two options to choose from: 
14:50 –16:20 

HM2: Accelerating regulatory approvals globally
Leader and Chair: Sharon Gorman, Director, EU Regulatory Policy, Pfizer, UK

Most pharmaceutical companies today are not only interested in obtaining a fast and efficient regulatory approval in Europe, US or Japan, but strive for rapid approvals globally. Patients are demanding that medicines are available to them as early as possible, regardless of geography. This session will discuss the key initiatives which have already accelerated, or have the greatest potential to accelerate, regulatory approvals regionally and globally. Speakers will consider the key benefits, limitations and hurdles in the practical implementation of the initiatives available, and discuss how they can evolve in the future to the benefit of patients and citizens worldwide.

14:55 - Introductory presentation

Speaker: Neil McAuslane, Scientific Director, Centre for Innovation in Regulatory Science, UK (TBC)

  • The impact of expedited/ facilitated regulatory pathways on approval times in mature markets and do they have a “halo” effect on approvals and roll out time to emerging countries?
  • Expedited / Facilitated regulatory pathways: What are seen by emerging regulators as the barriers and enablers to the successful use of these models for medicines
15:10 - Industry experience to date of established regulatory pathways

Speaker: Simon Bennett, Director, Global Regulatory Policy, EU Lead, Biogen, UK

  • The US, EU and Japan: Experience of current options for accelerating development and approval and how they compare. What lessons have been learned which can be useful globally?
15:25 - Options for accelerating approvals globally

Speaker: Julie O’Brien, Director Europe & International Regulatory Policy, Pfizer, Ireland 

  • Expedited/Facilitated  pathways: Overview and Options 
15:40 - International collaborations to speed approvals globally

Speaker: Emer Cooke, Director, Regulation of Medicines and other Health Technologies, World Health Organization (WHO)

  • WHO Initiatives and their potential impact
15:55 - Panel discussion
14:50 – 16:20 PS1: Electronic Product Information: what is happening now, future directions and opportunities

Leaders: Ronnie Mundair and Giovanna Ferrari, Regional Labelling Leads, International Labelling Group, Pfizer, UK

In the Pharmacovigilance Directive 2010/84/EC, Article 59, the European Commission (EC) 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 these 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; this included a recommendation to define key principles for the use of electronic formats for product information, and specific steps towards this goal were then outlined in the EMA Action Plan in November 2017. Since then, progress has continued, with EMA hosting a multi-stakeholder electronic product information (ePI) workshop in Q4 2018, further to which ePI ‘key principles’ were published for consultation. 
 
This session will provide an opportunity to discuss these recent developments in the area of ePI in Europe with key stakeholders, to consider how the ‘key principles’ may be implemented, and to reflect on what new benefits the electronic approach may offer to patients in accessing and understanding information about their medicines.

14:50 - Looking ahead: ePI in the digital health landscape of the future
Speaker: Giovanna Ferrari, Regional Labelling Leads, International Labelling Group, Pfizer, UK

15:10 - Considerations from the industry inter-association taskforce
Speaker: Aimad Torqui, Director Global Regulatory Policy, MSD and Chair, Inter-Association Task Force for e-labelling, the Netherlands

15:30 - Presentation name TBA
Speaker: Juan Garcia Burgos, Head of the Public Engagement Department, European Medicines Agency

15:50 - Panel discussion
16:20 – 17:00  Tea & coffee break
17:00 – 18:30 

HM3: Life after Brexit
Leader: Aileen Fisher, Head of Drug Safety and Regulatory Operations and Technical (CMC) Regulatory, Mundipharma, UK

Brexit has been a major component of UK and European politics over the last few months/years and both the pharma industry and Health Authorities have had to prepare for and adapt to a constantly evolving Brexit picture. As the uncertainty continues, this panel session aims to focus on “life after Brexit” for Europe and for the UK and to discuss topics such as “how Brexit has changed/will change the pharma industry in the UK”; “the MHRA plans for the future”; “the EMA perspective and future engagement with the UK”; and “the member state perspective”.

Panel discussion with the following speakers, moderated by the chair:

  • Anthony Humphreys, Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency (EMA), the Netherlands
  • Rita Purcell, Deputy Chief Executive, Health Products Regulatory Authority (HPRA), Ireland
  • Emma Du Four, Head of International Regulatory Policy & Intelligence, Abbvie, UK
  • Jonathan Mogford, Director of Policy, Medicine and Healthcare Products Regulatory Authority (MHRA), UK  
18:30 – 20:00  Symposium Networking Dinner  

 

1 October

8:55 – 9:00

Welcome to Day 2

 
Delegates choose from two options:
9:00 – 10:30 

HM4: Public hearings at the European Medicines Agency - two years' experience 
Leader: Sabine Haubenreisser, Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency (EMA)
Chair: Martin Huber, PRAC Vice-chair, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Public hearings are a new tool allowing the European Medicines Agency to engage with European Union (EU) citizens and listen to their views and experiences with a view to improving the safety of medicines.

The EU’s pharmacovigilance legislation provides for the Pharmacovigilance Risk Assessment Committee (PRAC) to hold public hearings in the frame of certain safety reviews of medicines. These hearings support the committee's decision-making by providing perspectives, knowledge and insights into the way medicines are used.

The first public hearing covered Valproate and related substances on 26 September 2017 and the second covered quinolone and fluoroquinolone antibiotics on 13 June 2018. This session will reflect on experience with these public hearings and will look at the lessons learnt and how these can be applied to future hearings. It will be followed by an interactive Q & A session.

9:00 - Short introduction and background on the development and experience with public hearings at the European Medicines Agency so far

Speaker: Juan Garcia Burgos, Head of the Public Engagement Department, European Medicines Agency, the Netherlands

9:10 - Impulse statements from the following speakers
  • Marco Greco, President, European Patients' Forum (EPF), Italy
  • Tara Kelly, Medicines Information Pharmacist, Irish Pharmacy Union (IPU), Ireland
  • Pär Tellner, Director, Regulatory, Drug Development and Manufacturing, European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium
9:30 - Panel discussion
  • Additional panellist: Sabine Haubenreisser, Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency (EMA) 
9:00 – 10:30

PD: Leading in a global environment
Leader: Samantha Cooper, Head of Professional Development, TOPRA, UK

In today’s global economy, companies are relying on a geographically dispersed workforce. To succeed, companies are building teams that offer functional expertise from around the world, combined with local knowledge of the markets they wish to enter, drawing on the benefits of international diversity, individual cultures with varied work experiences and alternative perspectives on strategic and organisational challenges. However, managers who actually lead global teams are up against stiff challenges; to create a successful team is hard when everyone is local and people share the same office, but when the team is widely dispersed and culturally diverse, communication can deteriorate, misunderstandings can happen and collaboration can become distrust.  In this session we have global leaders who will give an insight into their strategies and will answer questions about their experience.

Speakers:

  • Aaron Cousins, Vice President – Global Quality & Regulatory Affairs, Beckman-Coulter, UK
  • Angela Stokes, Vice President, Head of Global Regulatory Consulting, Syneos Health, UK
 
10:30 – 11:00 

Tea & coffee

11:00 – 11:40 TOPRA Annual Lecture
Speaker: Sebastian Payne, Director, Deloitte, UK

In the face of exponential technology and regulatory change, will life science regulatory survive or thrive?
The life sciences industry operates in an increasingly complex regulatory landscape. Regulators and Industry both face challenges in responding to developing trends and fostering innovation in the face of rapid change while keeping patient safety at the core of their purpose. We will explore some of those challenges and look at how by embracing them effectively organisations can not only drive progress, but thrive in the process. 
11:45 – 12:30 TOPRA Annual Review 
12:30 - 14:00 

Lunch

14:00 –15:30 

HM5MD1: Medical devices used to deliver medicinal products - new regulatory processes from May 2020 
Leader and Chair: Janine Jamieson, JCombinations AB, Sweden

Recognising the increasing convergence of medical technologies and medicines, the Medicinal Product Directive (2001/83/EC) is amended by the new EU Medical Device Regulation (EU) 2017/745 to ‘ensure appropriate interaction in terms of consultations during pre-market assessment, and of exchange of information in the context of vigilance activities involving such combination products.’ For MAAs submitted after 26 May 2020 a notified body (NB) opinion will be required on the safety, performance and usability of integral delivery device constituents. Many non-integral inhalation devices will also require NB assessment for the first time. 

EMA/CMDh guidance on procedural implications of Article 117 was published in February 2019, EMA QWP/BWP draft guidance on data requirements was published for a 3-month consultation on 3 June and TEAM-NB have set up a working group for consistent approaches across NBs. This session will bring together key stakeholders to discuss the paradigm shift in regulatory processes and interactions – and how to manage the imminent changes, complicated by expected NB resource constraints.

14:00 - EMA procedural guidance on Article 117

Speaker: Ivana Hayes, Seconded National Expert (Regulatory Affairs), European Medicines Agency (EMA), the Netherlands

  • EMA involvement in assessment of certain medical devices
  • Integral vs non-integral medical devices
  • Q&A on implementation of the MDR and IVDR – update
14:15 - EMA QWP/BWP guidance on quality requirements for drug–device combinations

Speaker: Nick Lee, Executive Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland

  • Background and interaction with notified bodies and industry
  • Core concepts of the draft guidance and timelines
  • Initial feedback on comments received from consultation
14:30 - New interactions with notified bodies

Speaker: Colm O'Rourke, Industry Engagement Officer, National Standards Authority of Ireland (NSAI), Ireland 

  • Notified bodies and their role in reviewing medical devices
  • TEAM-NB working group on Article 117
  • Proposed content of the NBO
14:45 - Industry preparations for new regulations

Speaker: Paul Scannell – Senior Manager, Device Technical Regulatory Lead, Mylan and Chairman of the Medical Device Taskforce, Medicines for Europe, Ireland

  • Impact of the new MDR on the pharma industry
  • Cross-industry collaboration and prioritised comments on guidelines
  • Expectations and hopes for the year ahead
15:00 - Panel Discussion
15:30 – 16:10 

Tea & coffee break

 
For the next session, delegates two options to choose from: 
16:10 – 17:40 

HM6MD2: Disruptive technologies: challenges and opportunities
Leader: Jonathan Trethowan, Vice President Regulatory and Scientific Policy, PharmaLex, UK
Chair: Laurence O'Dwyer, Scientific Affairs Manager, Health Products Regulatory Authority (HPRA), Ireland


Clayton M. Christensen, a Harvard Business School professor, coined the term disruptive technology in 1995. A disruptive technology is one that displaces an established technology and shakes up the industry (or a product that creates a completely new industry). Disruptive technologies, including artificial intelligence (AI), are becoming commonplace in our everyday lives and offer enormous potential to drive advances across the healthcare industry. Although there are applications in many areas, this session will focus on clinical research where these technologies may be used to reduce the time and costs to develop new products. Clearly this will benefit industry and patients, but it also presents new challenges to the regulatory systems we have in place. 

Our panel will introduce examples of disruptive technologies being implemented in clinical research and discuss how stakeholders need to collaborate to ensure the existing regulatory framework evolves so that we can adopt the benefits these technologies should bring.

Horizon scanning within the EU-Innovation Network

Speaker: Laurence O’Dwyer, Scientific Affairs Manager, Health Products Regulatory Authority (HPRA), Ireland

  • Overview of the EU-Innovation Network (EU-IN)
  • Objectives of horizon scanning
  • Co-ordinated approach to horizon scanning within the EU-IN
Challenges and opportunities from a healthcare provider's perspective

Speaker: Stuart Parks, Head of Clinical Engineering, NHS Scotland (Greater Glasgow & Clyde)

  • Current Challenges within Healthcare
  • Accelerating absorption / deployment of disruptive solutions
  • New opportunities for Industry
A Data Science perspective on AI-based technologies for accelerating drug development

Speaker: Bruno Boulanger, Chief Scientific Officer, PharmaLex Statistical Solutions, Belgium

  • More data doesn’t mean necessarily less risk
  • Let’s not repeat the same errors as with biomarkers
  • Opportunities for orphan disease and unmet needs 
A regulator's perspective on AI-based technologies

Speaker: Nikolai Brun, Director of Medical Evaluation & Biostatistics Division, Danish Medicines Agency (DKMA), Denmark

  • AI-based devices
  • AI-based analyses in regulatory submissions for drugs and devices
  • AI as a tool in regulatory assessment
16:10 – 17:40 PS2: Chemistry, Manufacturing and Controls (CMC): the ICH Q12 opportunity and filing in Japan
Leader: Sarah Fitzgerald, Director, Alexion, Ireland

16:10 - The ICH Q12 opportunity: Accelerating innovation through flexible regulatory approaches
Speaker: Alessandra Leone, Pfizer, Italy

Biopharmaceutical development and manufacturing are increasingly relying on rapid advances in science. Is it possible to evolve the regulatory framework to deliver safe, effective new treatments to patients faster? Through adoption of ICH Q12 tools and enablers, Industry and Regulators have a unique opportunity of applying science- and risk-based approaches to reduce the post-approval CMC change burden associated with innovative developments.

16:50 - Filing in Japan: CMC considerations and challenges
Speaker: Áine Kane, Pfizer, UK

An overview of the regulatory process for filing clinical and registration submissions for small molecules and biologics will be presented, including a comparison of the process to other regions and the challenges encountered.
17:40 –19:30  Networking reception 

 

2 October

9:00 – 9:05 Welcome to Day 3 
 
For the next session, delegates have two options to choose from:
9:05 – 10:35 

HM7: Convergence with HTA - the effects on development and regulatory processes
Leader and Chair: Susan Bhatti, Director EU Global Regulatory and Scientific Policy, Merck KGaA, Germany

The specific needs of patients as well as the requirements of health technology assessment (HTA) and payer/reimbursement bodies are increasingly influencing the development and market access of medicines. It is therefore essential these external stakeholders are integrated into the product development strategy and that their needs are considered when planning for regulatory submissions and product launch. Early consultation is important to ensure optimal and robust evidence is generated that will satisfy the needs of both regulators and HTA bodies. 

In Europe, the opportunity for parallel consultations with the European Medicines Agency and the European Network for Health Technology Assessment (EUnetHTA) provides applicants with a single gateway for discussions on their evidence generation plans. Patient representatives and healthcare professionals are routinely involved in the parallel consultation procedure to ensure their views and experiences are reflected. In this session representatives from health authorities, HTA bodies, patients and industry will present their experiences of parallel consultation and share any lessons learned in the panel discussion. 

9:05 - Experience of EUnetHTA with early dialogues for pharmaceutical products

Speaker: Chantal Guilhaume, Scientific Project Manager, EUnetHTA JA3 at Haute Autorité de Santé, France

  • Quantitative analyses of parallel scientific experience since July 2017
  • Review of main topics addressed 
  • Alignment between HTA bodies (HTAb) in final recommendations
  • Evolving approaches to increase patient’s contribution to final consolidated HTA recommendations
9:20 - Integrating multiple stakeholder perspectives in the evidence generation plan – an EMA perspective

Speaker: Michael Berngten, Head of Product Development Scientific Support Department, European Medicines Agency (EMA)

  • The experience with “Parallel Consultation” with HTAs: What are key learnings and trends?
  • Getting novel methodologies for evidence generation right: How to make sure that they are suitable for different stakeholders?
  • Patient input into the design of evidence generation plans: Which impact have we seen?
9:35 - European Commission perspective

Speaker: Flora Giorgio, Head of Sector, HTA, Directorate General Health and Food Safety (DG Sante), European Commission

9:50 - Panel Discussion
9:05 – 10:30

PS3: Clinical Trial Regulation
Leader and Chair: Christopher Price, Manager, Global Regulatory Oncology, Merck, Germany

2019 marks five years since the CT Regulation was first published in the Official Journal of the European Union. The implementation phase continues, since the availability of a functional EU clinical trial information system will determine when the CT Regulation comes into force across the EU.  

As EMA, Member States and industry collaborate to shape how the new clinical trials information system will operate, we will explore their different perspectives on the current approaches to implementation, their major hurdles faced and a look to the future. As EMA, Member States and industry collaborate to shape how the new clinical trials information system will operate, we will explore their different perspectives on the current approaches to implementation, their major hurdles faced and a look to the future. We will share hands-on insights from testers from industry on the portal and database functionality. We will discuss transition guidance documents and the challenges of practical implementation of the legislation.

Speakers:

  • Edit Szepessy, Policy Officer – Pharmaceuticals, Unit B4, European Commission
  • Other speakers to be announced
 
 
10:30 – 11:00  Tea & coffee break
 
For the next session, delegates have two options to choose from:
11:00 – 12:30

HM8: The future of regulatory affairs and the RA professional
Leader and Chair: Aileen Fisher, Head of Drug Safety and Regulatory Operations and Technical (CMC) Regulatory, Mundipharma, UK

Regulatory ways of working are changing dramatically as a result of progression in technology and systems, the availability of real world evidence and data and the expanding expectations of health authorities, HTA bodies and patients. Are we as regulatory professionals ready for this new world?

This panel discussion will explore the future of regulatory affairs and the RA professional: the way industry connects with health authorities; the impact of technology and systems on the way we work; the impact of real world evidence and its use for regulatory purposes; the progress of transparency; as well as the key attributes and capabilities required for the RA professional in this future world.

Panel discussion with these speakers, moderated by the Chair:

  • John Cogan, Head of Innovation and CTO, Kinapse, UK
  • Pat O’Mahony, Chief Executive, Clinical Research Development Ireland (CRDI) Ireland 
  • Michael Berngten, Head of Product Development Scientific Support Department, European Medicines Agency (EMA), the Netherlands
  • Nancy Pire-Smerkanich, Regulatory Associate Director, Regulatory Knowledge and Support, Southern California Clinical and Translational Science Institute, USA
  • Others to be confirmed
11:00 – 12:30

PS4: Do environmental regulations for genetically modified organism (GMO) containing IMPs create a hurdle for drug development in Europe?
Leader and Chair: Martin Lanigan, Manager, Global CMC Vaccines, Pfizer, Ireland

There is a significant increase in the current number of investigational medicinal products in development in Europe and Globally for hard to treat diseases.

Potentially the number of GMO containing IMPs in development are increasing exponentially. As a result, more companies are working with the regulations and guidelines for GMOs and clinical trials and have been experiencing challenges with the timelines to enable study approvals.

The Industry would like to work with the Regulators to improve the feasibility of Real-World implementation of the regulations to enable optimal drug development times.

We will discuss these challenges and the potential support to resolve these for the future.

11:00 - Introduction and definitions

11:05 - Current challenges
Speaker to be announced

  • Overview of current GMO Submission Process per Country (sequential or parallel CTA/ GMO process/ Classification: Deliberate or Contained Use / Timings
  • Risk mitigation strategies
11:25 - ATMPs - Major developments

Speaker to be announced

  • Updated EC Q&A (June 2018)
  • New European Commission – repository (overview) of 25 national GMO regulatory requirements created December 2017 
  • Common application Form (May 2018)
12:00 - Forward looking

Speaker to be announced

  • Harmonisation efforts (EFPIA / CTFG) to facilitate efficient CTA start up
  • Integrated approach with CTAs
  • Alignment of documentation requirements for EU and North America
12:30 – 12:40  Wrap-up of sessions 1–8 
12:40 – 13:10 Lunch
13:10 - 14:40

PD: Preparing your team for the future
Leader: Samantha Cooper, Head of Professional Development, TOPRA, UK

13:10 - Competence and accreditation: tools to support the development of you and your teams 

Speaker: Samantha Cooper, Head of Professional Development, TOPRA, UK

13:30 - Resilience and adaptability

Speaker: Joe Cheal, Lead Imaginarian and Trainer, Imaginarium Learning and Development, UK

Resilience is the ability to get in the driving seat and ‘bounce-back’ from events that life throws at us. Throughout this interactive session, we will explore a range of practical tools:

  • How to manage workload and work-life balance – tools for you and your team
  • How to develop a ‘growth mindset’ and adapt to change
  • How to look after yourself when times get tough
14:40 End of Human Medicines Symposium 

 

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TOPRA Symposium 2019

30 Sep - 2 Oct 2019
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