The Annual EMA Review of the Year, UK, 20-21 Nov 14

The Annual EMA Review of the Year, UK, 20-21 Nov 14

Taking place in the EMA’s new offices at Canary Wharf, the TOPRA Annual Regulatory Review is a firm favourite with European regulatory professionals as it is the key year-end event that encourages discussions on issues impacting the regulatory environment and considers the challenges ahead for the European Medicines Agency, national regulators, industry and other stakeholders.

Strategically important questions that will be addressed include
•    The EMA’s new working model – what is the experience and impact?
•    Is adaptive licensing the future approach to putting novel products on the market?
•    The European system in a global development model, why is it important for the regulatory professional?
•    How can patients play a more central role in regulatory decision-making?
•    Benefit risk decision making – can it be better communicated?
•    Transparency of data and information is the new norm; how will it affect you?
•    What should the regulatory system look like in 2020?

Preliminary programme

Download the programme as a pdf (subject to change)

The EU regulatory ecosystem from a global perspective

•    A review of how Regulators interact with each other in today’s global environment and about key topics of discussion in global forums.
•    Specific co-operations by Regulators in the creation of therapeutic guidelines and the lessons learned.
•    Regulatory challenges for industry associated with managing a product throughout its lifecycle.

Sabine Haubenreisser -  EMA liaison official at the US FDA, International Affairs, EMA
Jordi Llinares-Garcia - Head of Product Development Scientific Support, EMA
Sue Forda - Vice President, International Regulatory Affairs, ‎ Eli Lilly and Company, UK

Adaptive licensing and other early access initiatives
•    The early experience of the EMA adaptive licensing pilot programme and some of the key topics of interest to industry,
o    Which types of products the pilot is most useful for,
o    The optimal time point for engagement in the pilot
o    What improvements could be made to the process for future projects.
•    Views and experiences from the EMA, an HTA and industry
•    Experiences of the NEWDIGS safe harbour discussions.

Spiros Vamvakas – Head of Scientific Advice, Human Medicines Research & Development Support Division, EMA
Wing Cheng - Coordinator Scientific Advice, Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Sharon Gorman - Director, EU Regulatory Policy, Pfizer, UK
Plus comments from Robert Hemmings  – CHMP member, Chair of CHMP’s Scientific Advice Working Party (SAWP), and Unit Manager, Statistics and Pharmacokinetics Unit, MHRA, UK

Medicine development and authorization – a patient centered approach
•    How Industry intends to involve patients from early discovery and throughout the research
•    Development cycles towards approval to make research more focused on unmet health needs of patients and hence more targeted towards what "end users of healthcare" really want and need. The involvement and strategic role of patients in the regulatory process and how Regulators are using this input for their decision-making
•    How patients are currently preparing to take on increased responsibility to provide valuable and systematic input into the various processes.

Lode Dewulf - Chief Patient Affairs Officer, Vice-President UCB, Belgium
Isabelle Moulon -  Head of Patients & Healthcare Professionals Department, EMA
Jan Geissler -  Director, European Patients' Academy on Therapeutic Innovation.  (EUPATI)

Advancements in benefit/risk methodologies
•    An overview on the current status regarding methodology used in benefit-risk assessment for eliciting patient preferences on benefits and risks of a medicinal product and the implementation of these methods within the Agency and pharmaceutical industry.
•    To what extent are accepted methods available or need to be developed, e.g. through the Innovative Medicines Initiative 2

Douwe Postmas – National expert, Benefit-risk methodology project, EMA
François Houÿez - European Organisation for Rare Diseases (Eurordis), France
Susan Longman – Head, Drug Regulatory Affairs, Europe and Great China, Novartis Pharma AG, Switzerland
Demographic inf Switzerland |

The EMA’s new ways of working – the journey so far and what comes next
•    An overview of the main changes in the Agency’s way of working with regard to human medicines evaluation,
•    Progress so far from Procedural management and interfaces from view of variations and PSUR assessment plus therapaeutic area offices
•    Initial experiences with the changes from both EMA and industry perspectives.
•    An outlook of what to expect in 2015.

Michael Berntgen - Head of Scientific and Regulatory Management, EMA
Alberto Ganan – Head of Evaluation Procedures D, EMA
Irene Rager – Head of Evaluation Procedures E, EMA
Heidi Janssen - Head of Endocrinology, Metabolism & Cardiovascular, EMA
Plus comments from Melanie Carr (Head of Corporate Stakeholders Department, EMA) and Evdokia Korakianiti (Head of Procedural Management Department, EMA)

Clinical Trials, Transparency and data disclosure
•    The latest information on the policy on publication of clinical trial data
•    The latest information on the initiative for the EMA to develop and maintain the IT platforms that will support sponsors and EU Member State representatives to carry out their respective roles related to the submission, assessment and supervision of clinical trials in the EU
•    What is the current thinking to maintain confidentiality, and differential access but also meet the demands for transparency and data access.

Noel Wathion – Chief Policy Adviser and Head of Stakeholders and Communication Division (ad interim), EMA
Anabela Marçal  - Head of Compliance & Inspections Department, EMA
Sabine Atzor - Head of EU Regulatory Policies, F. Hoffmann-La Roche Ltd.

EMA Roundtable
This session will open with a presentation on the metrics of the EMA procedures followed by a Town Hall style debate. This will be jointly moderated by EMA and a NCA representative (from the national agencies) with participation by the heads of the main EMA committees.  There will be a mix of predetermined questions and open discussion from the floor.

Speakers and panellists
Tomas Salmonson - Chair of CHMP, MPA, Sweden
Anthony Humphreys - Head of Scientific Committee Support Department, Procedure Management and Business Support Division, EMA
Enrica Alteri – Head of Human Medicines Evaluation Division
Jordi Llinares – Head of Product Development Scientific Support Department, Human Medicines Research & Development Support Division
Anabela Marçal - Head of Compliance & Inspections Department, Inspections & Human Medicines Pharmacovigilance Division
Peter Arlett - Head of Pharmacovigilance Department, Inspections & Human Medicines Pharmacovigilance Division

and from the National Competent Authorities – the chairs of the key EMA committees:
Peter Bachmann, chair CMD(h) and BfArM, Germany
June Raine, chair PRAC and Director – VRMM, MHRA, UK


Who should attend?

This conference covers all the major areas of medicines legislation covered by the European Medicines Agency. If you are working at a Europe-wide level then this meeting is a must for you. It will provide you with practical advice on the working of the EMA within the European regulatory network.

Speakers include

National agencies, key officials from the European Commission, Heads of Unit from EMA, leading experts from within industry, pan-European policymakers and consultants who examine topical issues in European and global regulatory affairs.

Working Party includes

  • Judith Creba, Novartis, Switzerland
  • Christine Mayer-Nicolai, Merck, Germany
  • Angelika Joos, MSD (Europe) Inc, Belgium
  • Liz Gifford, Eisai, UK
  • Carolyn Hynes, GSK, UK
  • Tomas Salmonson, MPA, Sweden
  • Robert Hemmings, MHRA, UK
  • Peter Bachmann, BfArM, Germany
  • Fiona Reekie, Biogenidec, UK
  • Nick Sykes, Pfizer, UK (chair)

and from EMA:

  • Jordi Llinares Garcia (Head of Product Development Scientific Support Department)
  • Michael Berntgen (Head of Scientific & Regulatory Management Department)
  • Anabela de Lima Marçal (Head of Compliance & Inspections Department)
  • Marie-Hélène Pinheiro (Regulatory Intelligence & Best Evidence Department)
  • Martin Harvey Alchurch(Head of Communication Service)


Book online now

Registration fees

Member       £1,440.00

Non Member   £1,920.00

- Personnel in full-time education, working in academia (full-time) or working for a statutory regulatory body may be entitled to a discount on the above fees. Please contact the TOPRA office for details.

- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).

All fees are shown in Pounds Sterling and include VAT (where applicable)

20/11/2014 - 21/11/2014
The Annual EMA Review of The Year EMA London E14 5EU UNITED KINGDOM
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