Speaker Biography
Robert Smith
Robert Smith, BSc (hons), MSc, Pg Dip, MRPharmS, Qualified Person, is Director, Clinical Pharmacy Research Services. After qualifying as a pharmacist, he worked for 5 years as a clinical pharmacist specializing in geriatric medicine for the National Health Service in the UK. In 1989, he moved to work in the production department, specializing in liquids and semi-solids production and pack aging of solid dosage forms. After 8 years, Smith joined Covance Pharmaceutical Packaging Services to work as the warehouse and purchasing manager, where he was responsible for interpreting clinical trial protocol in order to design clinical trial packs to meet protocol requirements, In June 2001, he joined Genzyme Ltd. to set up the UK operations department of clinical Pharmacy Research Services. In November 2003, Smith passed the qualified person viva to become eligible as qualified person under the permanent provision arrangements. Currently he is the main qualified person certifying and releasing investigational medicinal products at Genzyme. In June 2004, he passed a post graduate diploma in pharmaceutical quality and good manufacturing practice. In his professional life, Smith has been responsible for setting up several new departments from scratch, transferring product and processes to and from different manufacturing sites, setting up quality systems, implementing and defining inventory systems and performing numerous GMP and third party supplier audits. He serves on the European Regional Steering Committee of the ISPE Investigational Products Community of Practice (IP COP) which fosters best practice within the clinical supplies industry. Additionally, he is the chair of the IP COP Global Regulatory sub-committee. This committee provides regular feedback to the regulators with respect to legislation and guidance.