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  Next Events
  		• Nov 2008 - 80335 Munich :
    Regulatory Affairs Forum
  		• Dec 2008 - London:
    TOPRA EMEA Update - Medicines Legislation
  		• Dec 2008 - 08014 Barcelona :
    9th Conference on European Electronic Document Management
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    Events in the life sciences industry

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    24.11.08 - 25.11.08 Regulatory Affairs Forum
      Le Meridien Hotel Munich , Bayerstrasse 41  
    80335 Munich , Germany
    • Scientific Advice and the Transatlantic Simplification Process
    • Centralised procedure: New market authorisation procedures and
    case studies
    • Update on Variation Regulations
    • Update on CMD(h) - Activities and the network
    • MRP / DCP procedures
    • Choice of RMS and availability of NCA resources
    • CMD(h) and CHMP referrals - interaction and case studies
    • Harmonisation of SmPCs of national MA's
    • The proposed new Pharmacovigilance Legislation
    • PSUR work-sharing and the link between PSURs and risk
    management plans
    • Transparency and public disclosure
    - Risk communication guideline
    - EudraCT and the impact of Paediatric Regulation
    • Risk management plans and Post Authorisation Safety Studies (PASS)
    • Risk management case studies
    • Telematics Roadmap and impact on regulatory business
    • Centralised procedure: eSubmission practicalities, Product
    Information Management (PIM) and case studies
    • NCA implementation of electronic initiatives: eCTD and NeeS
      Event website
    Contact Mrs. Talana Bertschi
      E-mail
    Further information Details
     
     
     
    02.12.08 - 03.12.08 TOPRA EMEA Update - Medicines Legislation
      Hilton London Canary Wharf Hotel 
    London, United Kingdom
    The aim of this conference is to provide a practical insight into the workings of the EMEA and to bring together regulatory personnel from the national agencies and industry in order to share regulatory knowledge, specifically when coordinated via the EMEA. It will cover all the major areas of medicines legislation covered by the European Medicines Agency. If you are working at a Europe wide level this meeting is a must for all levels of regulatory personnel. Speakers from the EMEA and representatives of the national agencies, the European Commission and Industry will offer their experiences.
      Event website
    Contact Mrs. Sarah Roberts
      E-mail
    Further information Details
     
     
     
    04.12.08 - 05.12.08 9th Conference on European Electronic Document Management
      Hilton Barcelona , Avenida Diagonal 589-591  
    08014 Barcelona , Spain
    During the past decades we dreamed, anticipated, waited for a future time when technology would shape a new landscape for EDM. Many of the
    components have been around for quite a long time. Others are just emerging. But now, for the first time, that future has come to being. EDM in
    many different shapes, spanning from home-grown systems to hosted repositories, has become the established method for managing official
    documentation. Registration dossiers are built electronically even for paper submissions and safety information is exchanged in electronic formats. Is
    this the end of the story? Certainly not but this much is certain: the future we dreamed of then, is now.
      Event website
    Contact Mrs. Talana Bertschi
      E-mail
    Further information Details
     
     
     
    04.12.08 - 05.12.08 Cardiac Safety
      Hilton Barcelona, Avenida Diagonal 589-591  
    08014 Barcelona , Spain
    The rapid development of Cardiac Safety standards in clinical and drug development practices, coupled with the increased regulatory scrutiny, has resulted in a momentous evolution of the cardiac drug safety field. The ICH-E14 guidance has been at the centre of the public and industry interest since its inception in 2003. After its finalization in 2005, focus has shifted to regional interpretation and implementation of the guidance and the development of cardiac safety compliance strategies by biopharmaceutical and other organisations. The implementation of the E14 guidance has recently also been broadened to cover
    oncology drugs and biologics, with associated challenges in terms of e.g. finding alternatives to the ‘thorough QT study’ in healthy volunteers. Concomitantly, the field of Cardiac Drug Safety has expanded beyond the repolarisation and arrhythmia issues and is now involving wider areas of drug induced cardiotoxicity, including vascular and tissue related toxicities. These topics and other will be discussed at the forthcoming DIA Cardiac Safety meeting, alongside presentations of new technologies and novel biomarkers for early detection and risk management of drug related cardiac toxicity.
      Event website
    Contact Mrs. Talana Bertschi
      E-mail
    Further information Details
     
     
     
    28.01.09 TOPRA Biotech Meeting: Understanding Your Biotech Product
      Radisson SAS Portman Hotel 
    London, United Kingdom
    Programme includes
    • Analytical characterisation concentrating on in
    vitro and biophysical techniques
    • Bio-analytical techniques concentrating on
    bioassays and agency expectations for bioassays
    • Impact of process variables on product quality
    • Comparability assessment example following
    a major process change (a case study from
    Wyeth)
    • Regulatory Agency perspective on comparability
    • Biosimilars
      Event website
    Contact Mrs. Sarah Roberts
      E-mail
    Further information Details
     
     
     
    15.03.09 Pharma-Biotech Product & Company Valuation
       
    Milan, Italy
    Know what determines the value of pharma & biotech companies.
    Gain a thorough understanding of key valuation terms, concepts, tools & techniques.
    Learn and practice how to assess and calculate the value of biotech companies.
    Learn and practice how to calculate the value of a development compound with an excel tool you can take home and use for any other pharmaceutical product in development.
    Gain expert insight and advice from Patrik Frei, who assessed and valued over one hundred products and companies in the life sciences industry.
      Event website
    Contact Mrs. Marie Stricklesse
      E-mail
     
     
     
    25.02.10 - 28.02.10 Int. Conference on Early Disease Detection & Prevention
      Hilton Munich Park Hotel 
    Munich, Germany
    This year's EDDP conference will focus on cardiovascular (cardiac disease and hypertension), metabolic (diabetes) and renal diseases. With a scientific program featuring a distinguished international panel of leading speakers, as well as a concurrent exhibition, this conference aims to:
     Discuss all elements relevant to early detection of disease prior to its clinical appearance
     Highlight the most updated technological and other means for disease prevention
     Encourage a free exchange of ideas among high-caliber presenters and participants
     Serve as a platform for the biotech/pharma industries to discuss ongoing projects and products
     Present general principles, ongoing academic/industrial research, and the latest achievements in the field
     Highlight biotechnological innovations and evaluate their applicability and cost-effectiveness
     Set the stage for prevention of disease by pharmacological, genetic or other interventional modalities

      Event website
    Contact Mrs. Orly Ishay
      E-mail
     
     
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