EMA SOLUTIONS - Key Persons

Dr. Xavier Luria

Job Titles:
  • Consultant
  • Director / CEO, DDR S.L
Dr. Xavier Luria is a consultant on drug development and drug regulation. He was Head of Safety and Efficacy at the European Medicines Agency (EMA) during 2005-2012, and previously held leadership positions in the biopharmaceutical industry for more than eighteen years, covering international clinical development, pharmacovigilance, biostatistics and medical affairs. At EMA, Xavier worked closely with CHMP, the highest regulatory committee in EU, and other regulatory bodies and committees. In addition to Dr. Luria's specialties in internal medicine, pharmaceutical medicine and biostatistics (Autonomous University, Barcelona), he has developed expertise in several specific therapeutic areas. Xavier has also completed a postgraduate qualification in clinical pharmacology, drug development and regulation (Tufts University School of Medicine, Boston). He is a recognized expert on regulatory systems and benefit-risk assessment (modelling, development and methodologies).

Gerry McGettigan

Job Titles:
  • Director / CEO, Kinesys Consulting Ltd
Gerry, a molecular biologist, has over twenty five years' experience in the biotechnology and pharmaceutical industries, in regulatory affairs, clinical development and business development, and in various Non-Executive Director roles. He has worked with large and medium pharma companies (Almirall, Spain and Glaxo, UK) and was Regulatory & Scientific Affairs Director of The Liposome Company, a US biotechnology firm. 

He founded the European regulatory affairs and product development consultancy company, GMG BioBusiness Ltd, which was sold to a top 5 CRO in 2005. He also set up and was CEO of the Catalan biotechnology development agency, Biocat, based in Barcelona. Gerry has worked with many clients on projects ranging from early stage regulatory strategy and complex biotechnology products, to clinical development and registration of novel healthcare products. 

Gerry has excellent relationships with top level business, science and governmental executives. Gerry set up Kinesys Consulting in 2007, helping companies with regulatory strategy, writing and submissions.