Patrick is a regulatory affairs expert with over 18 years' experience, and has been with NDA since 2007. He specialises in the preparation, review and submission of regulatory documentation and in project management of MA Applications, Renewals, Referrals, PSURs, and Variations for National and European procedures.
Area of Expertise
- 4+ years' experience gained within the European regulatory authorities with assessment of clinical and safety product licence variations, renewals, reclassifications and class reviews
- 14+years' hands-on experience within the pharmaceutical industry supporting and leading numerous projects such as clinical trials, scientific advice, MAAs, post approval and regulatory intelligence
- Strategic client support in the monitoring of regulatory developments, changes in European requirements and their impact on core business
- Strategic client support in regulatory intelligence and post approval activities
- Project management, preparation, review and submission of documentation for MAA applications, Variations, PSURs, Renewals, CTAs, Scientific Advice, Referrals
- Procedural support and co-ordination of response document preparation including leading interaction and negotiation with regulators
Before joining NDA
Patrick joined the pharmaceutical industry in 2001 in clinical research (phase I and II), transferring to the MHRA in 2002, as an Assessor within the Licensing Division. He then went on to join MHRA’s Vigilance and Risk Management of Medicines (VRMM) Division.