EuroMEEting - Genetic Alliance UK
EuroMEEting - Genetic Alliance UK
EuroMEEting - Genetic Alliance UK
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24<br />
THEME 5<br />
This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.<br />
Theme 5 | Wider Access (Generics/Switching)<br />
Christa Wirthumer-Hoche, Deputy Head, AGES PharmMed, Austria<br />
Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP,<br />
Belgium<br />
How can we meet the patients' need and expectations? This question will be<br />
analysed for generics and self-care medicine. The efficiency of the existing<br />
regulatory system (licensing procedures, handling of the lifecycle, switchprocedures)<br />
will be discussed. Pros and cons will be identified in order<br />
to optimise access to medicines - also in developing countries – as well<br />
as affordable treatment by generics and biosimilars; with a high level of<br />
information to patients and consumers, which is especially important for nonprescription<br />
medicines. The impact of the new changes in the pharmaceutical<br />
landscape – a new Directorate General (DG), a new European Commissioner,<br />
new strategic roadmaps as well as new pieces of legislation – will be elucidated.<br />
Tuesday, 29 March 2011<br />
09:00-10:30 Session 0501<br />
SWITCHING: IS THERE AN IDEAL ROUTE?<br />
Session Chair:<br />
Hubertus Cranz, Director-General, AESGP, Belgium<br />
This session will review the existing procedures (CP, DCP-MRP, national) that can<br />
be used to switch a medicine, the conditions to be met and their pros and cons in<br />
terms of resulting access, resources needed etc. What are the influencing factors<br />
companies consider when choosing their ‘switching pathway’ and what would be<br />
needed to make it the 'perfect route(s)'. These views will be confronted with that<br />
of the authorities at national and EU level.<br />
The Centralised Procedure and Switch<br />
Eric Abadie, Chair, CHMP, Chair Pharmacogenomics Working Party, European<br />
Medicines Agency; General Directorate, Afssaps, France<br />
View of a National Authority<br />
June Raine, Director, Division of Vigilance Risk Management of Medicines, MHRA,<br />
<strong>UK</strong><br />
What are the Important Factors when Selecting a Procedure?<br />
Speaker invited<br />
11:00-12:30 Session 0502<br />
ARE NEW SWITCHES IN LINE WITH THE EXPECTATION OF THE 'EMPOWERED<br />
PATIENT'?<br />
Session Chair:<br />
Anthony Humphreys, Head of Regulatory, Procedural and Committee Support,<br />
European Medicines Agency, EU<br />
A number of new switches-in-class have born lately in the field of migraine,<br />
obesity, BPH, etc. Are these meeting patients' expectations? How is patient<br />
need/expectation known? What are consumers after? Are there gaps not met in<br />
terms of self-care? What are the criteria that matter for consumers and patients<br />
in a switching process both by industry and regulators? All these challenging<br />
questions will be addressed in this session giving a prominent role to patients<br />
and consumers.<br />
Switch: What could be on the horizon?<br />
Stephen Mann, Pharmaceutical Consultant, Co-Editor, SelfCare Journal, <strong>UK</strong><br />
Voice of the Patients/Consumers<br />
Speaker invited<br />
14:00-15:30 Session 0503<br />
CHANGING REGULATORY ENVIRONMENT: IMPACT ON THE SELF-CARE<br />
SECTOR<br />
Session Chair:<br />
Shirley Norton, Deputy Director, Vigilance and Risk Management Division,<br />
MHRA, <strong>UK</strong><br />
The last year or so has brought a number of changes in the pharmaceutical<br />
landscape: a new commissioner, a new DG, new strategic direction of the<br />
Agency and of the HMA, early experience with the variation regulations and<br />
possibly new legislations in pharmacovigilance and in the context of falsified<br />
medicines. The session will reflect on the impact these changes may have on<br />
the self-care sector and how it may adapt.<br />
Overview of the New Legislative and Regulatory Landscape<br />
European Commission speaker invited<br />
Will the Self-Care Industry be Better Off?<br />
Speaker invited<br />
Views of a National Competent Authority<br />
Regulator invited<br />
16:00-17:30 Session 0504<br />
IS THE PATIENT/CONSUMER ADEQUATELY INFORMED?<br />
Session Chair:<br />
Zaide Frias, Head of Regulatory Affairs, European Medicines Agency, EU<br />
We are witnessing a breathtaking evolution of new forms of digital<br />
communication. All of this is unfolding so quickly that we do not have time<br />
to pause and reflect on what is happening. Providing 'the right information,<br />
in the right place, at the right time' is even more crucial in a non-prescription<br />
environment where the intervention of a healthcare professional is optional.<br />
This session therefore proposes to explore amongst industry, regulators and<br />
consumer organisations ways to improve the quality of the conventional<br />
forms of communication on non-prescription medicines, to debate ways<br />
to disseminate such information more effectively and the potential for<br />
individualising such information to the consumer/patient needs.<br />
Industry View<br />
Helen Darracott, Director of Legal & Regulatory Affairs, PAGB, <strong>UK</strong><br />
The Regulators’ Perspective<br />
Isabelle Moulon, Head of Medical Information, European Medicines Agency,<br />
EU<br />
Consumers’ Perspective<br />
Ilaria Passarani, Health Policy Officer, BEUC -The European Consumers’<br />
Organisation, Belgium<br />
The Patient’s Point of View<br />
Ian Banks, President, European Men’s Health Forum, <strong>UK</strong>