Enews - 22 November 2013
BSI is delighted to update you on a significant investment and expansion of our in-house medicinal expertise. We now have more in-house resource and breadth of medicines expertise than at any time in our history. To mark this expansion we have created a new brochure and we would also like to introduce you to our highly qualified experts.
BSI has proactively expanded our in-house medicinal expertise with four key objectives in mind:
- Firstly to ensure we have the right level of resources to efficiently manage the ever increasing number of devices we certify incorporating medicinal substances;
- Secondly to be confident that our experts are appropriately qualified to assess all of the drug substances used in the devices of today and devices for the future;
- Thirdly to be absolutely certain that we can meet the expectations of competent authorities in preparing the highest quality usefulness reports;
- Finally to be confident in the decisions we must make as a Notified Body when assessing changes to devices which may impact on the usefulness of the medicinal substance.
Our in-house knowledge and experience means that we are better-placed than ever before to anticipate the needs of European competent authorities. We do not submit medicinal dossiers to the competent authority until we have verified the usefulness of the drug. Our high quality review gives you added confidence and eliminates avoidable delays downstream in the consultation process.
So now, let us introduce you to our experts:
Dr. Tina Amini is an industrial pharmacist with a PhD in Pharmaceutics from Aston University, Birmingham and a Doctor of Pharmacy. Prior to joining BSI, Dr. Amini worked within Research & Development and Quality control functions in the pharmaceutical industry for over 17 years. During this time, Dr. Amini has worked in managerial and scientific capacities and her experience includes the formulation and processing of a wide range of pharmaceutical dosage forms including solids, liquids, parenterals and semi-solids taking products through from discovery to commercialisation.
Dr. Amini's field of expertise also includes targeted delivery systems, peptides and her extensive experience in submitting technical information to competent authorities for marketing authorizations has provided Dr. Amini with a thorough understanding of the requirements of European competent authorities and the European Medicines Agency.
Dr. Sophie Tabutin is a qualified QP and pharmacist with a background in drug formulation. She has over ten years of pharmaceutical industry experience with top pharmaceutical companies where she has worked developing and producing investigational drugs and leading clinical research.
Dr. Tabutin has worked on over 120 clinical trials in various therapeutic areas as a clinical pharmacist, developed liquid formulations for parenteral and non-parenteral use, coordinated regulatory strategies and reviewed clinical trial applications in several EU countries. She also led the design and implementation of a GMP quality system.
BSI is very proud of our unrivalled history in certifying medical devices incorporating medicinal substances. By strengthening our resources in this field, manufacturers can be assured that BSI will provide a highly professional and efficient service fully aligned with the requirements of the competent authorities and European Medicines Agency and in doing so deliver a direct and efficient certification process.
Dr Haydar Jaafar
General Devices Group Manager
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