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Published by: SMI Publishing, Ltd
Published: Oct. 25, 2006
Table of Contents
- Day 1
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Dr Michael Herschel, Director, Clinical Research, GlaxoSmithKline.
- 9.10 ENSURING A SUCCESSFUL TRIAL
- How to guarantee success
- Patient involvement in the design of clinical trials
- Strategies for successful patient recruitment
- Ensuring the successful execution of the organisation’s development projects
- Respect for the rights of study subjects
- Principles of trial design
- What merits success?
- Dr Michael Herschel, Director, Clinical Research, GlaxoSmithKline.
- 10.30 Morning Coffee
- 11.00 PREPARING FOR, HOSTING AND SURVIVING REGULATORY INSPECTIONS
- Quality assurance and inspections in clinical trials
- Regulatory inspections in clinical trials
- Complete inspection process
- Preparing for a regulatory inspection
- Hosting regulatory inspections
- Common inspection findings
- Minimising future impact
- Dr Ian Thomson, Medical Quality Assurance Advisor, Eli Lilly & Company.
- Dr Mark Parry, MGR LRL + ELANCO QA, Eli Lilly & Company.
- 11.40 THE EUROPEAN CLINICAL TRIAL DIRECTIVE
- Two years on - what’s changed? Who suffers?
- Dr Estelle Fritschy, Good Clinical Practice, Quality Assurance Auditor, Actelion Pharmaceuticals Ltd.
- 12.20 Networking Lunch
- 1.50 EFFECTS OF THE DIRECTIVE ON PUBLICLY FUNDED TRIALS
- The crisis that small businesses and academics face
- Complying with new regulations
- Taking advantage of the requirements that simplify the initiation and conduct of trials
- What influence do clinical researchers hold? Can they sway the decision-making process?
- Unnecessary delays or stoppages when conducting trials
- Inadequate financial support for academic groups
- Clarifying the precise requirements of the legislation for sponsors and investigators conducting non-commercial trials
- Dr Richard Sullivan, Director, Clinical & Translational Directorate, Cancer Research UK.
- 2.30 PATIENT RECRUITMENT
- Ensuring maximum participation
- Always an issue?
- What is the real cost of resources and services?
- Differentiating treatment costs
- Ensuring that decision makers are consulted early in the costing and resourcing process
- Dr Hartwig Gajek, Medical Director, Europe, Baxter BioPharmaceuticals.
- 3.10 Afternoon Tea
- 3.40 PANEL DISCUSSION
- Survival of the fittest - how are regulations affecting the industry
- How can we achieve harmonisation across member states?
- Does Europe still suffer from a lack of uniformity?
- Are there too many differences?
- Dr Ian Thomson, Medical Quality Assurance Advisor, Eli Lilly & Company.
- Dr Michael Herschel, Director, Clinical Research, GlaxoSmithKline.
- Pierre Mermet-Bouvier, Director, Wyeth Research.
- 4.20 IMPLEMENTING THE EU CLINICAL TRIALS DIRECTIVE IN GERMANY
- A focus on Investigator Initiated Trials (IITs)
- Highlights and lowlights of the German drug law after the transposition of the Directive
- Impact of the new law on IITs
- Where are the simplifications?
- GCP in IITs
- How much support can a pharmaceutical company provide for an IIT without becoming the sponsor?
- Dr Dagmar Chase, Managing Director, Clinrex GmbH.
- 5.00 Chairman’s Closing Remarks and Close of Day One
- Day 2
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Pierre Mermet-Bouvier, Director, Wyeth Research.
- 9.10 REGULATIONS IN THE FRENCH MARKET
- Case study - Wyeth
- Has there been a decrease in clinical research?
- The impact on the cost of trials
- Who are the ones most affected by the trial?
- Safety reporting
- Why France didn’t make the 2004 deadline
- Implementation into national legislation
- Pierre Mermet-Bouvier, Director, Wyeth Research.
- 9.50 IMPACT OF THE DIRECTIVE ON EASTERN EUROPE
- An attractive location for trials?
- Cost issues - can it lead to the loss of commercial research to Eastern Europe?
- What does the directive means for Eastern Europe?
- Understanding the various local governments and communities
- The impact of EU regulations on clinical trials in Eastern Europe
- Encouraging the co-operation of EU member states
- Dr Agnieszka Zareba, Regional Director, Clinical Research & Development, Wyeth .
- 10.30 Morning Coffee
- 11.00 HOW TO ASSURE QUALITY WHEN CLINICAL TRIALS ARE CONDUCTED IN EASTERN EUROPE
- An overview of the current CR environment
- Define the term "Eastern Countries"
- Current CR Environment overview - conditions we work under
- Key issues for success in CR, analysing:
- Regulatory environment
- Patient protection, media attitude
- Health systems - CR environment
- Investigators/sites - strategies for successful patient recruitment
- CRO competence and resource
- Import procedures
- Infrastructure and access to new technologies etc.
- GCP and NGO activities
- Dr Milen Vrabevski, Chief Executive Officer, Comac Medical Ltd.
- 11.40 HAS EUROPE BECOME A BETTER PLACE FOR CLINICAL TRIALS?
- Key issues and problems
- Concerns over the Directive
- Practical solutions to meet the challenges of working to the Directive
- Lessons learned from FDA inspections
- Investment in clinical trials in Europe and the world
- Dr Jean-Pierre Tassignon, Chairman, European Forum for Good Clinical Practice & Executive Vice President, PSI Pharma Support International.
- 12.20 Networking Lunch
- 1.50 NEW REGULATORY SYSTEMS (EXPERIENCES SHARED AND LEARNED)
- Case study - an example from Bio-Kinetic Europe
- The MHRA and CTA applications
- COREC the new ethics committee systems:
- Regulatory approvals within the NHS trusts
- Input from the CRSC
- Considerations for streamlining the regulatory pathway
- Dr David Bell, Medical Director, Bio Kinetic Europe Ltd.
- 2.30 CLINICAL TRIAL SUPPLY
- A new dimension to clinical trials that is creating waves in the industry
- Overview of relevant European regulatory framework and its implications for conducting clinical studies in EU member states
- Managing the movement, control, and release of investigational medicinal product (IMP) into and within Europe
- Role of the QP(s) and the importance of formalised agreements related to breakdown of responsibilities between centralised QP, national QPs, heads of local QA and responsible persons, and between sponsor and third party contractors acting on their behalf
- Identifying and agreeing responsibilities at the GCP-GMP interface
- Need for proper communication among all responsible for the integrity of product - tracking, and control of IMP throughout the distribution chain up to final destruction of unused product
- Dr Brian O'Neill, Global Head, CQA External Alliances, F.Hoffmann-La Roche.
- 3.10 Afternoon Tea
- 3.40 IMPLEMENTATION OF THE DIRECTIVE
- The UK perspective
- Significant variations in reporting procedures
- The main benefits and disadvantages of the Directive
- Good Clinical Practice (GMP) guidelines
- Good Manufacturing Practice (GMP) standards for medicines used in trials
- The responsibility of sponsors
- Regulatory guidelines
- Impact of the directive on members of the public
- Dr John Bolodeoku, Senior Director, Medical Affairs & Health Economics, Europe, Astellas Pharma EU Ltd.
- 4.20 EUROPEAN RECRUITMENT PROGRAMMES
- Focusing on patients
- Involving patients upfront
- Learning how they think
- Patients and investigators - contrasting views on recruitment
- Putting an effective programme into place
- Mr Richard Anderson, Chief Executive Officer, De Facto Communications.
- 5.00 Chairman’s Closing Remarks and Close of Conference
AbstractFollowing the runaway success of last years event, SMi are pleased to announce their 4th annual conference ‘Conducting Clinical Trials in Europe.’
This meeting will cover regulatory developments in the European environment with close attention being paid to the Clinical Trial Directive and it’s affect on the industry two years after its initial implementation. Recognised experts from within the EU community will share their experiences as we embark on a country by country journey to discover the impact of the directive, challenges faced and possible solutions to overcome them.
Our influential industry panel will give best practice advice on what components are needed for a successful trial, including key requirements for good clinical practice, quality assurance and inspections for clinical trials to ensure that your company maximises patient involvement and clinical trial supply
Gain an insight into the development strategies being employed from companies in the European market!
Hear cutting edge contributions from senior industry practitioners including:
- Dr Brian O’Neill, Global Head, CQA Management External Alliances, F.Hoffmann-La Roche
- Professor Heinrich Klech, Senior Medical Director, Eli Lilly
- Dr Hartwig Gajek, Medical Director, Baxter Europe
- Dr Agnieszka Zareba, Regional Director, Clinical Research & Development, Wyeth
- Pierre Mermet-Bouvier, Director, Wyeth Research
- Dr Michael Herschel, Director, Clinical Research, GlaxoSmithKline
- Estelle Fritschy, Good Clinical Practice, Quality Assurance Auditor, Actelion Pharmaceuticals
- Dr Ian Thomson, Medical Quality Assurance Advisor, Eli Lilly
- Dr Richard Sullivan, Director, Clinical & Translational Directorate, Cancer Research UK
- Dr Milen Vrabevski, Chief Executive Officer, Comac Medical
Key issues to be addressed at the conference include:
- EU CLINICAL TRIAL DIRECTIVE TWO YEARS ON: See what has changed from early implementation of the directive and its affect on academics and the pharmaceutical industry
- QUALITY ASSURANCE: Learn from key industry experts what it takes to prepare, host and survive regulatory inspections
- HAS EUROPE BECOME A BETTER PLACE FOR TRIALS? : Hear lessons learned and practical solutions to overcome the financial concerns that companies deal with when conducting clinical trials
- CLINICAL TRIAL SUPPLY: Discover its implications for conducting studies in EU member states and how this is affecting major pharmaceutical companies whilst learning how to ensure maximum participation in trials
- EUROPEAN PERSPECTIVES: Listen as leading experts discuss the impact of the directive from various European countries including Germany, France, UK and Central Europe
- NETWORKING OPPORTUNITIES: Collaborate with industry peers in an environment promoting information exchange
Get Full Details About This Report >>
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