Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.
11:00 Session 1507
JAPANESE REGULATORY SESSION: PMDA UPDATE - INITIATIVES AND
CHALLENGES FOR PROMOTING GLOBAL DRUG DEVELOPMENT
Session Chair:
Kyoichi Tadano, Director, Division of Planning and Coordination, PMDA, Japan
In this session, you will hear a detailed review of the past year at PMDA as well
as an overview of initiatives, milestones and current trends for the next year. You
will hear directly from senior-level PMDA representatives on issues that may
significantly affect your organisation’s regulatory operations
Future Directions and Challenges of PMDA
Tatsuya Kondo, Chief Executive, PMDA, Japan
Current Status of New Drug Reviews and Challenges to Promote Global Drug
Development
Satoshi Toyoshima, Executive Director and Director, Center for Product
Evaluation, PMDA, Japan
Current Projects for Promoting Global Drug Development including Japan
Yoshiaki Uyama, Review Director, Office of New Drug III, PMDA, Japan
11:00 Session 1607
PRODUCT INFORMATION MANAGEMENT – PROGRAMME TO MOVE ALL
PRODUCT INFORMATION IN THE CENTRALISED PROCEDURE TO PIM
Session Chair:
Steve Hasler, Vice President, Global Regulatory Operations, GlaxoSmithKline,
UK
The European Medicines Agency has issued a Statement of Intent regarding the
migration of all product information to PIM format by the end of 2011. The use
of PIM is strongly recommended for new products from mid-2010 and for
authorised products from when the product information is migrated. A
programme of work to achieve these goals is underway.
European Medicines Agency Plans to Transition PIM to the Standard Way of
Working
Olivier Simoen, Head of Programme and Project Management, European
Medicines Agency, EU
The Process for Migration to PIM
Mo Gould, Project Manager, FIT Consortium at the European Medicines Agency,
EU
Practical Experience of Migrations
Lynsey Flitton, Senior Regulatory Labelling Manager, Global Regulatory Affairs,
Wyeth Europa, UK
14:00 Session 1408
DRAWING THE BORDERLINE BETWEEN MEDICINES AND OTHER
CATEGORIES OF SELF-CARE PRODUCTS: A NEVER-ENDING TASK FOR
REGULATORS IN EUROPE?
Session Chair:
Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP,
Belgium
The session will review the regulatory requirements which apply in order to
clarify certain borderline issues between medicinal products and other product
categories, namely medical devices used in self-care, food supplements and
cosmetics. Despite the provisions introduced by Directive 2004/27/EC to bring
clarification in the area, differences in assessment between EU Member States
remain frequent, resulting in a regulatory framework potentially uncertain for
both industry and consumers.
Latest Developments in the Borderline between Medicines and Food
Lucca Battistini, Manager, Food Related Issues, AESGP, Belgium
Hot Topics/Stand-Alone Sessions
Borderline Medical Devices - Medical Products
Peter Lassoff, Vice President, Europe, PAREXEL Consulting, UK
Borderline Medical Products vs. Cosmetics
Speaker invited
14:00 Session 1508
PHARMACEUTICAL MEDICINE (IN COLLABORATION WITH IFAPP)
Session Chair:
Jean-Paul Deslypere, Business Development Manager, Life Sciences - Asia
Pacific, SGS Life Sciences Services, Singapore
Pharmaceutical Medicine (PM) can be defined as the discipline of medicine that
is devoted to the discovery, research, development and support of ethical
promotion and safe use of pharmaceuticals, vaccines, medical devices and
diagnostics. Thanks to its important role in overseeing the process of
developing new therapeutics it will greatly contribute at improving the
standards of health and the quality of life within society. Although PM already
has existed for more than 30 years it is still not well known within the medical
profession and even amongst the clinical research community. This session aims
to familiarise DIA participants with the specialisation of PM, and its professional
representative groups: IFAPP and CEPM. The past and future achievements of
IFAPP and CEPM will be highlighted as well as the major targets of these
organisations: recognition of PM as a separate medical specialty and training of
all involved in PM. For this, courses need to be set up and accredited, while
participants who successfully finish the courses need to be certified. The
experience with PM in the different continents will be discussed with
contributions not only from very experienced countries but also from countries
were PM is just organising itself. Last but not least some important future
projects co-sponsored by the European Union authorities will be presented.
IMI 16
Fritz Buehler, European Center of Pharmaceutical Medicine, ECPM Executive
Office, University Hospital Basel, Switzerland
Pharmaceutical Medicine in Japan
Stewart Geary, Vice President, Eisai Co. Ltd., Japan
Pharmaceutical Medicine in China
Frank Fan, Medical Director, Wyeth Ltd., China
Session 1608
THE FUTURE OF TELEMATICS IN EUROPE
Session chair:
Raun Kupiec, Senior Director regulatory Affairs – Process Management,
Genzyme, Netherlands
The importance of electronic interchange between applicant and regulator and
between regulators increases month by month but where is it heading overall.
The direction of the European Medicines Agency is laid out in the Telematics
Master Plan but this needs to be regularly redefined as new drivers are
identified. Industry is a key stakeholder in this but what direction does it feel
should be taken and does it align with those defined by the regulators? The
eCTD specification is under redevelopment and in time this may have a major
impact on all stakeholders. Progress will be reported and future directions
defined.
The European Medicines Agency Telematics Master Plan – Continuing Progress
Tim Buxton, Head of Sector, Project Management, European Medicines Agency,
EU
The Industry Vision for Telematics support for European Regulatory
Procedures
Steve Hasler, Vice President, Global Regulatory Operations, GlaxoSmithKline,
UK
eCTD Next Major Version – The European perspective
Stan van Belkum, Programme Manager, Medicines Evaluation Board, The
Netherlands
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