14^th Global Pharmacovigilance and Clinical Trials Summit March 16-17, 2020 Sydney, Australia

Dr. Steen Ottosen is a physician with a medical degree from the University of Southern Denmark and clinical experience from general surgery as well as family medicine and specialization in public health medicine from the University of Oslo, Norway. He has 20 years of experience in drug safety, medical and regulatory affairs and quality management. He is the founder of the drug safety consultancy company Steen Ottosen ApS with consultants and clients in the US and Europe. Previously he has been leading a number of drug safety organizations as well as serving as Qualified Person for Pharmacovigilance around the world including companies like La Jolla Pharmaceutical, Arena Pharmaceuticals, Amgen, PRA International, Pharmion, Genmab, and Lundbeck.

Open access literature databases for mandatory drug safety literature screening during clinical development and post-market – equal access to new science for pharmaceutical companies.

Dr. Ujwala Salvi is a Founder & Chief Executive Officer, at NUCLEON Therapeutics LLP, Mumbai (India). She has an MBA in Finance from the Indian Institute of Management (IIM), Kolkata & Doctorate in Applied Biology from Mumbai University, has over 15 years of experience across the Global Pharmaceutical/CRO, Tier I Medical Devices and BPO industry.

Process Optimization and Role of Artificial Intelligence in Global Pharmacovigilance.

Daniela Di Cosmo has been working in the Pharmacovigilance field since 2013, firstly in Hospitals in Italy, and then abroad (Czech Republic, UK, Ireland, and Denmark), handling all possible tasks in both clinical (all clinical trials’ phases) and post-marketing. She has always operated on a global level, yet facing the possible new changes given by local legislation (and how the affiliates handle them), and therefore she is well aware of the everyday challenges that all this requires (current role: Pharmacovigilance Manager).

Principles of causality assessment and sender’s comment: everyday challenges and possible solutions