The 9th annual review of the activities of the European Medicines Agency (EMA) and the national agencies that work within the European regulatory system will take place in the new EMA offices at Canary Wharf.
This event will:
- Address all the major areas of medicines legislation coordinated by the EMA
- Provide practical advice on the workings of the EMA within the European regulatory network and how the national agencies contribute
- Feature a wide range of speakers and panellists from national agency heads to European Commission officials, EMA senior leadership, industy leaders, pan-European policymakers and consultants
What topics will be covered?
- Developing new medicines: What is the regulatory role in fostering and supporting pharmaceutical innovation?
- Optimising your regulatory strategy by using accelerated regulatory pathways
- Data Sharing and Disclosure: Operational Aspects of EMA Policies
- Involvement of patients and Health Care Providers in in the work of EMA and it’s committees
- Operational efficiencies with post-approval activities
- Reflections on 2015 – Review of evaluation highlights, surveys and progress in the area of telematics
- The new EU Clinical Trial Regulation – how will the EU Portal and database support implementation?
- PLUS-The Regulator Roundtable - your opportunity to hear from senior EMA staff members, EMA Committee chairs and NCA representatives for this popular Town Hall-style session, and their reflections on the year gone by and strategic priorities for 2016. There will be a mix of predetermined questions and open discussion from the floor
(Topics are subject to change)
EMA, regulatory agency and patient group speakers
- Peter Arlett - Head of Pharmacovigilance Department, Inspections & Human Medicines Pharmacovigilance Division, EMA
- Peter Bachmann - Chair CMD(h), BfArM, Germany
- Michael Berntgen - Head of Scientific & Regulatory Management Department, Human Medicines Evaluation Division, EMA
- Melanie Carr - Head of Corporate Stakeholders Department, Stakeholders & Communication Division, EMA
- Emil Cochino - Scientific Officer, Anti-infectives and Vaccines Office, Scientific & Regulatory Management Department, EMA
- Rosa Giuliani - EMA HCP working party, Italy
- Zaïde Frias - Head of Human Medicines Research & development Support Division, EMA
- Robert Hemmings – Chair SAWP, MHRA, UK
- Jordi Llinares Garcia - Head of Product Development Scientific Support Department, Human Medicines Research & development Support Division, EMA
- Georgy Genov - Head of Signal Management Service, Pharmacovigilance Department, EMA
- David Haerry, co-chair of Patients' and Consumers' Working Party (PCWP), European Aids Treatment Group (EATG)
- Anne-Sophie Henry-Eude - Head of Access to Documents Service, Corporate Stakeholders Department, EMA
- Tony Humphreys - Head of Procedure Management & Committees Support Division (ad interim), EMA
- Anabela Marçal - Head of Compliance & Inspections Department, Inspections & Human Medicines Pharmacovigilance Division, EMA
- Isabelle Moulon - Head of Patients & Healthcare Professionals Department, Stakeholders & Communication Division, EMA, HCP
- Francisco Peñaranda - Head of Business Data & Analytics Department, Information Management Division, EMA
- Marie-Helene Pinheiro - Principal Regulatory Advisor, EMA
- June Raine - Chair PRAC and Director - VRMM, MHRA, UK
- Ana Rodriguez - Head of Clinical and Non-Clinical Compliance Service, EMA
- Tomas Salmonson - Chair CHMP, MPA, Sweden
- Olga Solomon - Deputy Head of Unit SANCO D5 – medicinal product, authorisations, European Medicines Agency, European Commission,Belgium
- Enrico Tognana - Business Pipeline Coordinator, Science and Innovation Support Office, Regulatory Science and Innovation Support Department, EMA
- Corinne de Vries - Head of Science and Innovation Support Office, Regulatory Science and Innovation Support Department, EMA
- Noël Wathion - Chief Policy Adviser, Head of Stakeholders & Communication Division (ad interim), EMA
- Rachel Adams - Senior Director and Regulatory Therapy Area Lead, EMEA, Janssen Pharma R&D
- Judith Creba - Executive Director, EU Regulatory Strategy, Novartis Pharma AG, Switzerland
- Lode Dewulf - Chief Patient Affairs Officer, Vice-President UCB, Belgium
- Emma du Four - Senior Director Regulatory Policy & Intelligence, Abbvie, UK
- Carolyn Hynes - Senior Director, Global Regulatory Intelligence, GlaxoSmithKline, UK
- Angelika Joos - Executive Director Global Regulatory Policy, MSD (Europe) Inc., Belgium
- Clare Lavery - Policy Director, Chief Medical Office, AstraZeneca, UK
- Christine Mayer-Nicolai - Head Global Regulatory & Scientific Policy, Merck KGaA, Germany
- Mairead Noone, - Director, Global Regulatory Affairs, GlaxoSmithKline, UK
- Fabien Peuvrelle - Director, Knowledge Management, Regulatory Intelligence & Policy, EMEA Regulatory Affairs, Celgene R&D, Switzerland
- Geert Preuveneers - Executive Director Regulatory Affairs Europe, MSD (Europe) Inc., Belgium
- Fiona Reekie - Director of Regulatory Policy, Europe and Global Emerging Markets, Biogen Idec Ltd, UK
- Nick Sykes - Senior Director, European Regulatory Policy, Pfizer, UK
Further EMA and industry speakers to be confirmed.
Did you know? The Awards ceremony to celebrate Regulatory Excellence takes place on 18 November, the day before the start of this conference. If you're going to attend the The Annual European Medicines Agency Review of the Year and Outlook for 2016, why not also attend the Awards ceremony? For more information, go to www.regulatoryaffairsawards.org.
This course offers 16 CPD hours for successful completion
Why is Continuous Professional Development important?
As a professional in regulatory affairs you have a personal responsibility to maintain your level of knowledge and competence; you are therefore encouraged to participate in Continuous Professional Development.
CPD is important to you as;
- It demonstrates to your employer that you have planned, updated and maintained your knowledge and experience
- It enables you to develop your knowledge and experience for your present role and any potential future roles.
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Course price (including VAT):
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For the 25% discount please contact firstname.lastname@example.org for the code
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