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Informa Life Sciences

9th Annual Phase I Clinical Trials: Improving safety, reducing costs and increasing efficiency in Phase I studies

  
   
Download Programme
– updated on 08 February 2010


9th Annual Phase I Clinical Trials: Improving safety, reducing costs and increasing efficiency in Phase I studies
Register online or Call:
Life Science Customer Services
Tel: +44 (0) 20 7017 7481
Email:  registrations@informa-ls.com
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Inspirational after lunch speaker just announced:

Gerald Ratner, Former Chief Executive, Ratners jewellery, made famous for successfully rebuilding his jewellery brand after his own words almost destroyed it.

At this meeting you will:

  • Save money, improve safety and increase efficacy in your Phase I clinical trials
  • Understand the consequences of the TeGenero experience on phase I trials
  • Avoid product failure by learning exactly how to satisfy your regulators
  • Listen to case studies about creative, low cost design to speed Phase I studies
  • Develop strategies for improving CRO selection and management
  • Hear the latest industry and regulatory perspectives on how to successfully plan and run a QTc Study
  • Establish safe and rational dose selection/escalation in FIM studies
  • Learn from more than 40 Phase I experts! 

Key speakers include:  

-           Professor Kent Woods, Chief Executive Officer, Medicines and Healthcare Products Regulatory Agency, MHRA

-           Professor Sir Gordon Duff, Chairman, Commission on Human Medicines

-           Dr John Warren, Medical Assessor, MHRA, Member Scientific Advice Working Party, EMEA

-           Fethi Trabelsi, Director, Scientific and Regulatory Affairs Anapharm, a PharmaNet Development Group company

-           Willem Jan Drijfhout, Senior Vice President Early Development Services, PRA International

-           Dr Jal Chiesa MD FFPM ICR, Medical Director, Covance

-           Harsukh Parmar, Director, Discovery Medicine, Respiratory & Inflammation Therapy Area, AstraZeneca

-           Dr. Thomas Senderovitz, M.D., Vice President Global Exploratory Development, R&D, UCB

-           Greet Musch, Head of Department, Research & Development, Federal Agency for Medicines and Health products, Belgium

-           Inspirational after lunch speaker: Gerald Ratner, Former Chief Executive, Ratner’s Jewellery

-           Colette Strnadova, Ph.D., Senior Scientific Advisor, Health Canada

-           Gregory I. Berk, MD, Chief Medical Officer, SuperGen, Inc.

-           Alun W. Bedding, Director, Biostatistics and Programming Development Partners, Drug Development Sciences, GlaxoSmithKline

-           Dr. Priyadarshini Roy, Clinical Pharmacologist, Novartis, India

-           Borje Darpo, Pharmaceutical Consultant, formerly Vice President, Chief Medical Officer, Daiichi Medical Research UK and USA

-           Georg Ferber, Group Head, Biostatistics, Novartis Pharma AG

-           Piet H. van der Graaf, Head of Pharmacokinetics & PK/PD, Department of PDM, Pfizer Global Research & Development, Sandwich UK

-           Paola Tocchetti, Director Drug Metabolism and Pharmacokinetics, NicOx Research Institute

-           Dr. Stefano Persiani, PhD, Director, Dept. of Drug Metabolism, Pharmacokinetics and Dynamics, Rottapharm spa

-           Paul Cutler, Genomics Research, GlaxoSmithKline



Who Will Attend?

Managers and senior executives from:

  • Clinical Development
  • Clinical Operations
  • Pharmacoinformatics
  • Clinical pharmacology
  • Clinical Research
  • Clinical Trials
  • Data Management
  • Clinical Imaging
  • Outsourcing
  • Contract Management
  • Biostatistics
  • Pre-clinical Development


Don't Miss

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HEAR what some of last years' delegates had to say;

 

"Good networking opportunity and very informative"

Mark Bee, Business Development Manager, PAREXEL INTERNATIONAL

 

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"Good for networking, gives the current state of art for phase I studies"

Wilma Bagches, Associate Director, MerckSerono

 

Good for networking, gives the current state of art for phase I studies

 

"Phase I is [the] future of drug development"

Denislav Granchev, IT Manager, Comac Medical LTD

 

Phase I is [the] future of drug development

 

"Exchange of new strategies in early drug development at a high level. Informa Life Sciences sets a high standard. Stimulating atmosphere."

Eveline Wesby-Van Swaay, group manager & Global Drug Safety Physician, Astra-Zeneca

 

Exchange of new strategies in early drug development at a high level. Informa Life Sciences sets a high standard. Stimulating atmosphere.

 

 

Questions to be answered at this year’s conference:

  • What are the main expectations of the new EMEA guidelines for FIM studies?
  • In FIM, what is the right starting dose?
  • What are the new innovative phase I study designs being successfully used at the moment?
  • What are the challenges of conducting Phase I trials in patients?
  • How accurate is animal data when testing in humans?
  • What are the challenges of proof of mechanism in phase I?
  • Importance of ADME in Phase I ?

Visit the link below to read more about the revised application process from the MHRA;

http://www.iir-events.com/IIR-Conf/page.aspx?id=5357

 

 

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Key Presentations

 



Register Now!
Register online or call:
Life Science Customer Services
Tel: +44 (0) 20 7017 7481
Email:registrations@informa-ls.com
Group Discounts
For more info call:
Simon Lau
Tel: +44 (0) 20 7017 7165
Email:simon.lau@informa.com
Speaker Opportunities
To discuss opportunities call:
Siobhan Corry
Tel: +44 (0) 20 7017 7135
Email:siobhan.corry@informa.com
Sponsorship and Exhibition
To discuss opportunities call:
Sophie Ahmed
Tel: +44 (0) 20 7017 7266
Email:sahmed@iirltd.co.uk