Services
- Proven experience in infectious diseases ( Influenza, bacterial infections and other viral infections)– providing input into clinical trial design or protocols. Selection or management of CROs . Experience in conducting clinical trials phase 1 to IV in compliance with ICH GCP standards.
- Creation of disease registries and their management
- Management of CROs and third party vendors and other stakeholders
- Organisation of advisory boards
- Strong network of International thought leaders both on a local or international level
- Organisation of scientific medical symposia
- Establishment and conduct of compassionate use programmes
- Specific experience of interactions and meetings with regulatory health authorities, ministry of health or other national bodies from public health groups to academic networks
- Access to patient groups
- Market research on various aspects of drug development
Contact
James Smith Co-Pharma
Kienberghof 9
CH-4450 Sissach
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Short Biography
Dr. James Smith worked in the pharmaceutical industry in clinical research & medical affairs groups for over 30 years and was responsible for various infectious disease portfolio drugs in the area of malaria, HIV, bacterial infections , RSV and influenza.
During his time as International Medical Leader, Tamiflu, for Roche based in Basel, Switzerland he implemented Roche’s scientific and medical activities for Tamiflu® organizing symposia, authoring publications, and co-ordinating clinical studies. There was a additional focus on supporting governments and other key groups in their pandemic planning efforts.
Prior to that Dr. Smith has worked in pharmaceutical companies and CROs and has been involved in the clinical development of many different classes of products, including CNS drugs & Cardiovascular agents
James completed a PhD in pharmacology from the University of London, UK. He started his pharmaceutical career with CIBA-Geigy in England and then moved to their Swiss headquarters in 1983.
He was awarded the Swiss Association of Pharmaceutical Professionals Diploma in Pharmaceutical Medicine, January 2001.