Pharmacovigilance & Drug Safety

Mario Bertazzoli is a physician and a registered specialist in Human Reproduction Pathology. He received both medical and specialization degrees from the University of Milan, Italy. He worked since 1995 for international pharmaceutical companies as pharmacovigilance and pharmaco-epidemiology physician. He is currently the Head of Corporate Drug Safety and Reference Physician to the EU Qualified Person for Pharmacovigilance for the Helsinn Group. He is founder and treasurer of the International Society of Pharmacovigilance, Swiss-Austrian Chapter.

Worldwide Pharmacovigilance (especially US, EU, Switzerland, China and Japan), Benefit-risk management and Pharmacoepidemiology.

Microbiology, Genetics, Immunology, Virology, Immunopharmacology, Cell Biology

Microbiology, Genetics, Immunology, Virology, Immunopharmacology, Cell Biology,

Saad Shakir qualified in Medicine in 1976 and worked in hospital medicine for eleven years before moving to general practice. He has been working in pharmacovigilance & pharmacoepidemiology for more than a decade, initially at the Medicines Control Agency (MCA) in the UK then in the international pharmaceutical industry.He was appointed as the Director of the Drug Safety Research Unit (DSRU) in Southampton in 1999. The DSRU is an academic Unit associated with the University of Portsmouth. At the DSRU he leads a research team with an active programme for monitoring and studying the safety of medicines. Saad Shakir is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London, a Fellow of the Faculty of Pharmaceutical Medicine, a Fellow of the International Society of Pharmacoepidemiology and a Member of the Royal College of General Practitioners in the UK. He continues to practice clinical medicine part-time. He has worked and advised on many drug safety issues including product withdrawals and major safety hazards. He is an author of many publications in scientific journals on pharmacovigilance and pharmacoepidemiology and is a member of the editorial board of the journals of Pharmacoepidemiology and Drug Safety. Saad Shakir has led, co-ordinated and participated in many postgraduate educational and training programmes. He supervises postgraduate students for higher degrees and has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology.

Pharmacovigilance risk management and risk minimisation and its effectiveness

1980 - 1994 Qualified University of London, Guy\\\\\\\'s Hospital Medical School followed by hospital medicine and clinical research: general medicine, 6 years in renal medicine, principal investigator in London, Birmingham, and Manchester attached to Renal Unit Royal Infirmary 1994 -1999 Senior Medical Assessor UK Medicines Control Agency – Senior Medical Assessor in Pharmacovigilance Assessment Group. 1999 - 2005 Senior Medical Director in a global CRO – Parexel Scientific and Medical Services – with responsibilities in pharmacovigilance and clinical trials. 2005 - 2007 Deputy Qualified Person for pharmacovigilance for Janssen Cilag Since July 2007, Dr Edwards has been a Principal Consultant in Pharmacovigilance and Drug Safety with NDA Regulatory Science Ltd based in Leatherhead, Surrey, UK. In addition, he chairs the QA panel overseeing the training of UK pharmaceutical physicians on behalf of the UK Faculty of Pharmaceutical Medicine and he is Director of ISoP Secretariat Ltd, is on the ISoP Executive Committee and is Treasurer as of November 2012. He is also Vice President in the Alliance Clinical Research Excellence and Safety (ACRES). He is co-chair of PharmaHUF in the UK & Ireland.

hospital medicine and clinical research: general medicine

Kieran O’Donnell has over 15 years of PV and since 2006 has been leading European and Global PV operations, gaining broad experience in PV QMS; Benefit-risk management; Signal Detection & Management; PSURs & DSURs; RSI development; ICSR and SUSAR submission; Inspection (MHRA GCP & PV and FDA PV inspections; ISO 9001:2000; and responsible roles such as the RP for EudraVigilance and Deputy QPPV for Pharmacovigilance. In addition to his PgC Pharmacovigilance, he has been a member of the RQA PV Committee since 2008 and is a Fellow of PIPA. He joined TMC in June 2014.

Pharmacovigilance, EudraVigilance, Signal Detection, Benefit-risk management

Marco Manfredi MD, pediatrician and gastroenterologist, is now adjunct professor at Parma University. He carried out his education at Parma University where completed his PhD in Pediatric Gastroenterology in 2004. Currently he is working as Assistant Manager in Pediatric Gastroenterology at “Pietro Barilla” Children's Hospital in Parma, Italy. His main fields of interests are Helicobacter pylori infection, coeliac disease, gastrointestinal infectious diseases, functional gastrointestinal diseases, and Probiotics. Dr Manfredi published more than 75 papers, included chapters of textbooks. He is editor of three textbooks on “Helicobacter pylori infection”, “Gastrointestinal Endoscopy in Children” and on “Probiotics in Children” published by Nova Science Publishers, New York, USA. He is serving as an editorial board member of several reputed journal like “Clinical Microbiology: open access” and “Frontiers in Pediatric Gastroenterology and Hepatology” and expert Reviewer for journals like BMC Gastroenterology, Saudi Journal of Gastroenterology, BMC Case Reports. He is a member of Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition.

Gastroenterology, Hepatology and Nutrition

Uqbah Iqbal is the recipient of Research University Fellowship Scheme, MyBrain 15 (MyPhD) Postgraduate Scholarship Programme, graduate on Time Award, Outstanding Student Award, the Youngest Ph.D. in History Holder and the only Malaysian achieved a Ph.D. in History in conjunction with the 43rd Convocation of the National University of Malaysia. He’s authoring 71 books/ebooks and his 320 articles appeared in international and national journals. In the process, he became Executive Editor, Chief Editor, Associate Editor, Guest Editor, International Advisory Board, Conference Organizer, and Review Committee. He has also reviewed the book Pharmacovigilance and Pharmacoepidemiology, Clinical Research in Psychology. International Journal of Pharmacovigilance, International Journal of Modern Pharmaceutical Research.

Pharmacovigilance, Pharmacology, Neuropharmacology