Phone: +44 141 899 0081

Dr Gonzalo Calvo

ex-CHMP member Spain, Clinical Assessor AEMPS

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    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-CMC Assessor, MHRA, UK

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    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 Pharmacovigilance, MHRA

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    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.

Karl-Heinz Huemer

ex-PDCO member, Austria

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    Karl-Heinz Huemer studied medicine and biology. After receiving his PhD he worked for many years as a physiologist at the University of Vienna (research and teaching). After completion of his MD he continued his medical specialisation (Facharzt) also in physiology with internships in clinical pharmacology and ophthalmology, while also being member of the ethics committee at the Medical University of Vienna. In 2007 he became clinical assessor at the Austrian Medicines & Medical Devices Agency, soon also appointed as delegate in both the Paediatric Committee (PDCO) and the Scientific Advice Working Party (SAWP) at the European Medicines Agency. Since 2023 he is working as a regulatory & scientific consultant.

Marco Antonio Moreno

ex-CMC Assessor, AEMPS, Spain

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    Marco Antonio Moreno has worked for over 20 years as CMC Assessor, in the Spanish Agency for Medicines and Medical Devices (AEMPS) in Spain, and in the pharmaceutical industry with broad experience in all Chemistry, Manufacturing and Control (CMC) and Quality aspects through preclinical, late-stage  and commercial development of medicinal products across multiple indications, including during NDA/MAA procedures and post-approval related activities. He became an EMEA Expert during his tenure at AEMPS. Marco has also worked in a broad range of pharmaceutical companies in key roles, such as at QualitecFarma as Regulatory and Scientific Affairs Manager; and at Pfizer as Regulatory Affairs Therapeutic Area Manager. In 2004 he was appointed as Expert for the “European Pharmacopoeia Group of Experts 10A”, after obtaining the approval of the European Pharmacopoeia Commission. He has also served as a Scientific reviewer for the Journal of Pharmaceutical and Biomedical Analysis, Chromatographia, European Journal of Pharmaceutical Sciences and Pharmaceutical Research. As part of his professional activities, he performed as Lecturer in various Spanish Universities for graduate and Master’s students. He has written a wide variety of scientific articles and presented at a range of congresses. He received his Ph.D. degree in Pharmacy with Honours from the University of Madrid in 2000 and in 2005. He obtained the Post-Graduate Specialist degree in Industrial and Galenical Pharmacy, as well as a Master´s Degree in European Regulatory Affairs and Procedures from the University of Barcelona.