Asian Pharma

THURSDAY 15 SEPTEMBER 2005
ASIAN PHARMA SEMINAR

Location: Chatham House, 10 St James' Square, London SW1Y 4LE
(Nearest Tube Stations: Piccadilly Circus or Green Park)
Time: 17.00 - 19.30 pm (followed by reception)
For Prices and To Register Please click here.

Chair:
Dr Gillian Walley, Global Head of Proposals, MDS Pharma Services

Speakers: Chris Barnett, Director of Quality and Compliance, Pharmaceutical Development Services "Importation of clinical trials materials: Contracts, Technical Agreements and Qualified Persons"

Dr Ian Wilding, Scientific Advisor, Pharmaceutical Profiles Overcoming developability problems in oral drug delivery using human absorption and scintigraphic studies

Dr Stephen Little, CEO, DxS Ltd "Strategic alliances for the delivery of Personalised Medicine"

Background:

Chris Barnett
With a number of examples from recent experience, Chris Barnett, a QP with a number of years experience in investigational products will attempt to highlight some of the pitfalls, and to provide some guidance to companies wanting to import products into Europe for use in clinical trials.

The requirements for the importation of products for investigational purposes has changed significantly, compared with the previous situation, since the transposition of the Clinical Trial Directive into UK law in May 2004. There still remain, however a number of misunderstandings regarding the legalities of importation, and the requirements for QP certification of imported product. The study sponsors, the manufacturers, the importers, the packagers and the Qualified Persons all have their roles to play, and it is becoming more and more important to have written agreements in place to describe these roles. Furthermore, the Regulatory Agencies are routinely scrutinizing these agreements during their inspections to ensure that there are no unnecessary gaps, and that the requirements of the legislation are being complied with.

Ian Wilding
Dr Wilding is the scientific Advisor for Pharmaceutical Profiles and was the recipient of the prestigious 2005 Controlled Release Society "Career Achievement Award in Oral Drug Delivery". He has over 230 research papers/abstracts in biopharmaceutics, drug delivery and intestinal absorption. His presentation will focus on both the use of gamma scintigraphy to visualize the interaction between drug, dosage form and gastrointestinal physiology and how the proactive adoption of human drug absorption studies, using remote controlled capsules, has become a proven, reliable and cost effective method of gathering 'formulation relevant' biopharmaceutical data to accelerate decision making in early drug development.

Stephen Little
Dr Stephen Little is Chief Executive and co-founder of DxS Ltd, a pharmacogenomics service and personalised medicine business based in Manchester, UK. Prior to forming DxS, he was a board and executive team member at AstraZeneca Diagnostics with overall responsibility for R&D within the business.

Current medicines are only safe and effective for a proportion of patients. For example, AstraZeneca's lung cancer treatment Iressa is proving successful in Japan however efficacy in Europe and the USA is still subject to lengthy debate! Advances in technologies have enabled the link to be made between a patient's genetic profile and in this case, their response to therapy. This presentation will focus on the challenges faced by pharmaceutical companies when the drug requires a diagnostic to identify those who will benefit from the prescribed treatment.

This meeting is supported by our Annual Sponsors Gold Sponsors: The Harten Group

Silver Sponsors: Bridgehead International -
Clinphone Group
Global Outsourcing Review -
Harrison Clinical Research
Inveresk Research -
Japan Airlines -
Jetro London -
MDS Pharma Services
Pharmaceutical Development Services -
Pharmaceutical Profiles

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Attendance Fees: 1 Seminar £55 + VAT
4 Seminars £155 + VAT
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