Regulatory Rapporteur May 2012

  • Focus - Clinical Trials
  • PLUS
  • Perceptions and realities of clinical safety of biosimilars – Part 2
  • Nutraceuticals & functional food regulations in key emerging markets
  • The new Medicinal Products and Health Products Safety Reform Act

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Focus on...Pharmacovigilance (PV)

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TOPRA's PV resources ensure individuals working within PV are kept informed of this ever-changing regulatory environment.

Pharmacovigilance Meeting 28/06/12
The MHRA perspective on the new pharmacovigilance legislation
Special PV Edition of Regulatory Rapporteur
Pharmacovigilance: The New European Picture

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PharmaTimes World News

  • GSK pays $213 million to raise stake in Theravance to 26.7%
  • EU Parliament seeks urgent review of drug monitoring
  • Pfizer's Torisel loses out to Bayer's Nexavar in PFS trial
  • USA boosts Alzheimer's funding as prevention trial is launched
  • New global vaccine plan is flawed - MSF

PharmaTimes Clinical News

  • ReNeuron’s UK stem-cell trial edges towards Phase II
  • New pharma funding for Dundee’s Division of Signal Transduction Therapy
  • Pharma needs to take strategic approach to patient-reported outcomes, says report
  • Combination of ‘push and pull’ mechanisms needed to stimulate NTD R&D
  • AG Mednet technology tackles imaging trial errors