Dr Gonzalo Calvo
ex-CHMP member, Clinical Assessor AEMPS, Spain
- Gonzalo is a physician with broad experience advising pharma and biotech companies on regulatory and clinical development matters. For a number of years, he has been supporting Kinesys’ clients through our Advisory Board, in which Gonzalo is a key figure. He is currently Head of the Clinical Pharmacology Department at the Hospital Clinic, one of the major hospitals in Barcelona. He was CHMP member for Spain, and Clinical Assessor at AEMPS, for 10 years. Together with CHMP colleagues across the EU, he had responsibility for all decisions pertaining to new drug MAAs in the European Union. Gonzalo has held various other clinical and regulatory roles, including in pharmacovigilance. During his tenure at CHMP and AEMPS he chaired and participated in a number of EMA / CHMP working parties (cardiovascular, efficacy, and others), set up the Scientific Advice function at AEMPS, and assessed Scientific Advice Applications at EMA and AEMPS. Gonzalo was president of the European Association of Clinical Pharmacology and Therapeutics (EACPT) from 2011 to 2015.
Laura Millichamp
ex-Quality Assessor, MHRA, UK
- Laura has over 15 years’ experience in Regulatory Affairs and is the Founder of InsideReg, a Regulatory Affairs Consultancy specialising in novel therapeutics in pre-clinical and clinical phases of development. She leads multi-disciplinary teams providing strategic and technical advice on a broad range of products including biologicals, innovative biotech products, radionuclides, drug device combinations, and mRNA. Laura has in depth experience of the preparation and submission of applications for Marketing Authorisation, Orphan Designation, FDA Type C meetings/Scientific Advice, Clinical Trial Applications/INDs and works across a range of therapeutic areas, including in rare diseases. Laura previously worked as a Senior Consultant at Parexel, where she advised clients on regulatory strategy, and prepared successful Regulatory Authority submissions for activities at all stages of product development. Prior to joining Parexel, Laura was an MHRA Assessor and CHMP Expert for over 7 years, where she assessed a broad range of Marketing Authorisation Applications and variations, provided Scientific Advice at the UK and EU level, and contributed to the development of guidelines for topical and paediatric product development.
Dr Panos Tsintis
Ex Head of Safety, EMA, and ex Head of Pharmacovigilance, MHRA
- Dr Panos Tsintis qualified and trained in internal medicine in the UK. He has over 35 years’ experience in Pharmacovigilance and drug development. Panos is a former senior regulator with the UK MHRA and European Medicines Agency (EMA) where he was Head of Pharmacovigilance and Post-Authorisation Safety and Efficacy of Human Medicines Sector. In these roles, Dr Tsintis performed clinical assessment for marketing authorisations and the full range of pharmacovigilance benefit-risk evaluations. Panos was actively involved in developing and introducing pharmacovigilance and risk management guidelines in the EU since 2005. He also acts as senior advisor to the Council of International Organisations of Medical Sciences (CIOMS) and is involved in CIOMS working groups on Risk Minimisation, Patient Involvement, Benefit-Risk of medicines and Artificial Intelligence in Pharmacovigilance. Dr Tsintis currently runs his own consulting company PLM Med Ltd. providing support and advice to pharmaceutical companies and other clients on product lifecycle management of medicines including pharmacovigilance, regulatory inspections and interactions with global regulatory authorities on benefit-risk.
