Dr Glyn Belcher has over 30 years experience in clinical development and drug safety in the pharmaceutical industry. Dr Belcher qualified in medicine from Oxford and Cambridge universities and received his PhD in neuropharmacology from the latter. After a number of years in hospital internal medicine he joined Schering and worked in clinical research in the UK affiliate before moving to headquarters in Berlin, first as head of cardiovascular clinical research and later as head of a new safety department covering clinical development activities. Dr Belcher moved to Takeda European Research and Development Centre in London where he was Director of International Drug Safety and EU QPPV for nine years. He most recent full-time position was as Head of Drug Safety and Risk Management and EU QPPV at Biogen Idec in UK. In this position he took a lead role in the safety aspects of the European approval and post-marketing surveillance of Tysabri and other Biogen medicines. After retiring from this position, he has continued to consult for Pharmaceutical Industry companies as well as committing more time to teaching and mentoring in the areas of pre-marketing and post-marketing drug safety and benefit risk management.
Fernanda Ferrazin, former GMP inspector, has gained long experience as GMP inspector and director, first in the Ministry of Health where he served from 1984 to 2004, and later at the Italian Agency for Medicines (established in 2004). From 2009 to 2013 she has been involved in the safety of medicines (as Director of the Pharmacovigilance Office and alternate member of the PRAC - Committee for Pharmacovigilance Risk Assessment of the European Medicines Agency EMA in London). From 2013 to 2015 has verified regulatory compliance due to the updating of the registration dossiers and CTDs of the medicines by MAH companies, in particular in case of GMP production API production delays and semi-finished/finished products. Teacher on GMP and Pharmacovigilance issues in several University Masters and Training Courses. Speaker at numerous scientific congresses.
Calin is the Chief Executive Officer of Drug Development Consulting Services (DDCS), established in 1999, a pharmacovigilance quality assurance consulting firm located Luxembourg. He has worked for 15 years in drug development, clinical research, pharmacovigilance and quality assurance. He is a medical doctor. Calin has conducted more than 140 pharmacovigilance systems audits for various pharmaceutical companies, has audited transfer of safety databases and MedDRA recoding, PSUR processes, CCSI processes, signal detection, has participated in the preparation, conduct and follow-up of various regulatory inspections in the area of pharmacovigilance in Europe, has advised several EU and non-EU pharmaceutical companies in establishing/improving a pharmacovigilance system in conformity with current regulatory requirements.
Calin has been a Eudraviglance Trainer since 2004 and has trained more than 250 Eudravigilance and XEVMPD courses and has been a professional trainer in the use of the EudraVigilance Data Analysis System for European National Competent Authorities and the European Medicines Agency between 2008 and 2013.
Marco Sardella, Chief Pharmacovigilance Ofﬁcer EU-QPPV-ADIENNE Pharma & Biotech Dr. Marco Sardella is a PV Person with signiﬁcant experience in setting up pharmacovigilance and risk management systems worldwide (experience with EMA, USA, Canada, Switzerland, Russian Federation, ASIA, Middle East). Former European QPPV of Gentium S.p.A/Jazz Pharma. Today, overall Responsible for Global Safety and Pharmacovigilance for the Group ADIENNE Pharma and Biotech in the position of Chief Pharmacovigilance Ofﬁcer & European QPPV. Experience with development of CTD safety modules for hemato-oncological products [successful approval in US, Canada, (New Drug Applications) and EMA (Marketing Authorization Applications)].
Responsible for Safety in international pre-approval and post-approval safety studies.
From 2000 to present, dr. Laura Sottosanti is the Scientific Administrator at the Pharmacovigilance Office of the Italian Medicines Agency – (AIFA).
Member of various national and international commissions , most significant:
Italian Representative in several meetings of the European Commissions for the discussions on new pharmacovigilance legislation of the Expert Group on the delegates acts, Coordinator of the Signal Analysis Working Group between AIFA and the Regional Center for Pharmacovigilance, Italian member of the signal management review technical working group (SMART WG) at EMA, reference at national level for BEMA (benchmarking of AIFA) activity, Italian Trusted deputy for Eudravigilance.
Teacher on Pharmacovigilance issues in several University Masters on Pharmacovigilance. Speaker at numerous scientific congresses. Author of various publications on topics related to pharmacovigilance.