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  • Regulatory NewsRegulatory News

    MHRA to Land a New Interim Chief Executive Ahead of Brexit

    Beginning 20 September, June Raine will be the new interim Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA). Raine will replace Ian Hudson, who will step down after 18 years with MHRA, including six years as chief executive. In addition to Hudson, John Wilkinson, director of devices at MHRA, will step down at the end of October. In June, Wilkinson discussed with Focus several initiatives that MHRA is working on, including how to de...
  • Regulatory NewsRegulatory News

    UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers

    No one knows what UK pharmacovigilance will look like after the UK leaves the EU, and that uncertainty puts the many Qualified Persons Responsible for Pharmacovigilance (QPPVs) residing in the UK in a precarious position. According to the UK’s independent academic Drug Safety Research Unit, which organized a meeting last week on the topic of pharmacovigilance post-Brexit, "At worst, this will deal a severe blow to UK pharmacovigilance" as pharmaceutical companies "...
  • CHMP Appoints New Vice-Chair

    The European Medicines Agency (EMA) has appointed Ian Hudson as the new vice-chair of its Committee for Medicinal Products for Human Use (CHMP) after its previous vice-chair was appointed to the position of chair of the CHMP. Hudson ( PDF ) has been a member of the CHMP since 2004, and has also served on the Paediatric Committee (PDCO), the Committee for Proprietary Medicinal Products (CPMP) and the guideline consistency group. Outside of EMA's advisory groups, he curr...