Ioana Venet, Pharm.D.

Ioana helps to define and implement CMC (Chemistry, Manufacturing and Controls) strategies, to support clients to take their products from development to marketing authorization. She provides guidance on questions to be discussed when seeking scientific advice (EMA, National), and contributes to the responses to address issues raised by the Regulators. Her scientific expertise focuses on products containing active substances of chemical or plant origin. 

Having worked as a pharmaceutical assessor for 10 years (MHRA and ANSM), Ioana has significant scientific and technical skills in the field of Quality of medicines and an excellent knowledge of the regulatory authorities. During this time, she gained in depth understanding of quality requirements for active substances and drug products (e.g., various oral administration forms, injectables, topicals, etc.), for applications for marketing authorization and variations, for innovant products and generics. Ioana has a specific expertise in the control of the microbiological quality, she was Principal Assessor for the evaluation of the rapid microbiological methods. During her time as a Pharmaceutical Assessor, she also participated in European work at the EDQM as a national expert, for the assessment of CEPs for active substances and discussions within the Microbiology group of experts. 

During 8 years at the MHRA, Ioana led and provided scientific and regulatory advice to companies before and after submission of their applications. She made many successful presentations to expert committees (the UK Committee for Chemistry, Pharmacy and Standards (CPS), the Committee for Human Medicines (CHM), the Co-ordination Group for Mutual Recognition and Decentralized Procedures (CMDh), the EU Quality Working party (QWP)). Having worked on all types of EU (centralized, decentralized, MRP, referrals) and UK national procedures, for products submitted under diverse legal bases, she is familiar with the regulatory requirements and strategies. She collaborated with the inspectorate to address GMP issues and provided support to pharmacovigilance colleagues on pharmaceutical quality matters. 

At the ANSM, her responsibilities focused on the evaluation of the quality aspects of medicines proposed for authorization in EU under the Centralized procedure and providing quality input for CHMP scientific advice (e.g., definition starting material, strategy for the impurities control, stability study results extrapolations, etc.). In addition, she participated to the elaboration and revision of EU guidelines and collaborated with other Regulatory Agencies in EU. 

Just before joining VCLS, Ioana worked for 2 years for the European Pharmacopoeia at the EDQM, being involved in the elaboration of new texts providing guidance for the development and control of certain types of biological products (e.g., bacteriophages), the maintenance of existent Ph. Eur. texts (e.g., for the control of microbiological quality, the control of the quality of water for pharmaceutical use). She has also been involved in the preparation of the Ph. Eur. strategy for reducing the use of in-vivo (animal) tests for the control of products (i.e., removal/replacement of the rabbit pyrogen test by alternative in-vitro tests). 

Just after graduating from her Pharmacy studies, Ioana worked for 3 years in the pharmaceutical industry, in France and the UK, in Regulatory Affairs, being responsible for the life cycle management activities for innovators, generics and OTC products. 

In addition to her Pharmacy Doctor Degree (Pharm.D.) from Paris-V University, Ioana holds a master’s degree in the Control of Quality of Medicines, with a specialization in the control of the microbiological quality. 

Ioana is based at our Boulogne offices in Paris.