Webinar—MAH Essentials: Ensuring Compliance for European Market Entry

Frank has over 30 years of experience in industry in a broad Regulatory Scientific field across all product types and multiple therapeutic areas including (pediatric) rare diseases and leads a team of subject matter experts in Regulatory Sciences to advise, support or lead overall regulatory strategy development and execution.

Frank’s broad and varied experience within the drug development industry includes significant interaction with the European Medicines Agency (EMA) and majority of national regulatory agencies across Europe, Middle East, CIS Region, Africa and to a certain extent LATAM, APAC, Canada, Australia, US. Regulatory interactions include but are not limited to scientific advice/protocol assistance, orphan applications and maintenance, pediatric investigation plans, early interactions, pre-submission meetings with EMA and/or Rapp/Co-Rapp and full marketing authorisation application pre-submission and full procedural support.

Frank has led various due diligence activities for product or portfolio acquisition and supported various Mergers & Acquisitions and served as international expert witness in arbitration court cases. Aside from Regulatory Scientific experience, Frank also held positions in Business Development, In/out-licensing, Commercial, Marketing & Sales, Quality and Pharmacovigilance.

Eleonora Casucci is Vice President Quality and Compliance at ProPharma. She has over 20 years of pharmaceutical industry experience, and her leadership has driven global business expansion, particularly in cell & gene therapies. With experience in quality assurance and as a qualified person, as well as commissioning, qualification, and validation, she has demonstrated a commitment to operational excellence. Eleonora has a master’s in molecular biology with a thesis on assay application at the Italian Centre for National Research.

Thomas Chatzopoulos brings over 25 years of Pharmacovigilance expertise, having held senior roles at leading pharmaceutical companies including Grünenthal, Novartis, and Boehringer Ingelheim. As Vice President of the QPPV Office at ProPharma, he oversees QPPV and LPPV activities, leveraging his extensive experience in setting up global PV systems and preparing them for audits and inspections.