Trk 14: Clin Safety/PV [
clear filter]
10:30am EDT
#225: One Size Does Not Fit All: Best Practices for Right-Sized Signal Management Systems
Chair
Senior Benefit Risk Management Director, Quintiles Inc.
Over 15 years in PV, spanning CRO, regulatory authority and company. Areas of special interest are EU post-marketing safety systems & product benefit-risk management. Adjunct Lecturer in international PV at Tufts University School of Public Health and Community Medicine in Boston...
Read More →
Speakers
Senior Researcher, Uppsala Monitoring Centre
Ola Caster is Senior Researcher at the Uppsala Monitoring Centre and affiliated with the Department of Computer and Systems Sciences, Stockholm University. He has nearly ten years’ experience from research and development in global pharmacovigilance, with formal qualifications PhD...
Read More →
Director for Data Mining and Informatics Evaluation and Research, OTS, CDER, FDA
Dr. Francis is the Director of the Data mining and Informatics Evaluation and Research Group in the Office of Translational Sciences, CDER, FDA.In that capacity he directs a trans-disciplinary group of senior sciences to test, create and operate data analysis program facilitating...
Read More →
Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented...
Read More →
Tuesday June 28, 2016 10:30am - 11:45am EDT
113B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm EDT
#249: Current Topics for Pharmacovigilance in Japan
Chair
Senior Vice President, Chief Medical Officer, Eisai Co., Ltd.
Stewart Geary has worked at Eisai since 1996 in PV, clinical safety and regulatory science. He was a member of the CIOMS VII, VIII and IX Working Groups, and currently serves on the Executive Committee of JAPhMed and the Editorial Advisory Boards for Applied Clinical Trials and Pharmaceutical...
Read More →
Speakers
Executive Consultant, Director of Drug Safety Outsourcing Planning, CAC Croit Corporation
Drug Safety & Pharmacovigilance expert. EWG for ICH E2B, and Rapporter for ICH E2D. Lecturer of many educational seminars worldwide more than 20 years. Executive Consultant, and Auditors for Global Pharmacovigilance Compliance.
Technical Officer, Application Review Division I, Office of Relief Funds, Pharmaceuticals and Medical Devices Agency (PMDA)
Technical officer of PMDA since Feb.2010 and technical officer of Office of Relief Funds of PMDA since Jan. 2014.
Tuesday June 28, 2016 2:00pm - 3:15pm EDT
113B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
4:00pm EDT
#272: How Can We Build Reliability and Quality When Outsourcing Pharmacovigilance?
Chair
Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining...
Read More →
Speakers
Director, Global Pharmacovigilance Case Management, Alexion
Lillian is a Doctor of Chiropractic with over 19 years’ healthcare experience, including clinical practice, teaching, drug safety/pharmacovigilance & medical affairs. The last 3 years, she provided safety expertise companywide & for external partners. She has worked to develop valuable...
Read More →
Consulting Specialist Leader, Deloitte
Kelly has over 17 years of industry and consulting experience in Life Sciences. She has significant consulting experience in the areas of Quality, Pharmacovigilance, R&D and Regulatory Affairs. Projects she has led and provided extensive subject matter expertise on include, Process...
Read More →
Tuesday June 28, 2016 4:00pm - 5:15pm EDT
113B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm EDT
#350: Evaluating the Impact of Adverse Event Information from Solicited Programs on Benefit-Risk Profiles: Is It Worth the Effort?
Chair
Senior Group Director, Pharmacovigilance Innovation Policy, Genentech, A Member of the Roche Group
Bruce has a PhD in pharmacology with 20+ years experience in the pharma/bio industry, mostly in drug safety but he has also worked in other areas such as pre-clinical research. During the past 5 years, Bruce was Head, Drug Safety at Genentech before transitioning into a new role in...
Read More →
Speakers
Group Manager, Vigilance Intelligence and Research Group, Medicines and Healthcare products Regulatory Agency (MHRA)
Mick has been with the MHRA’s Vigilance Intelligence and Research Group for 9 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the MHRA’s signal detection systems. He is also responsible for two large European projects to improve drug safety...
Read More →
Vice President, Foresight Group International
Jamie Portnoff is a Vice President and Global Practice Leader with 15 years of experience in Life Sciences. In the past 10 years Ms. Portnoff has delivered a broad scope of business solutions including multiple PV operational and organizational integrations. Prior to Foresight, Ms...
Read More →
EU QPPV, Executive Director, Global Patient Safety, Amgen Ltd
Sue has been in the pharmaceutical industry for over 25 years. Sue joined Amgen in 2013 as EU QPPV, based in Cambridge, UK. Sue is an honorary Fellow of PIPA and sits on the Efpia PV Expert Group. Prior to joining Amgen Sue spent 3 years at Eisai Europe as Head of International PV...
Read More →
Head of Global Drug Safety, Merck KGaA
Heike is a registered physician, practiced in internal medicine at university hospital in Berlin and Erlangen, Germany. She holds specialist registration in internal medicine and diplomas in public health, epidemiology from the University in Heidelberg, Germany and a diploma in tropical...
Read More →
Wednesday June 29, 2016 2:00pm - 3:30pm EDT
108A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
4:00pm EDT
#371: FDA and PatientsLikeMe: Exploring the Use of Patient-Generated Data in Drug Safety
Chair
President and Co-Founder, PatientsLikeMe
As President and Director of PatientsLikeMe, Benjamin Heywood is responsible for setting the company vision to improve healthcare and accelerate research, while directing its business growth strategy. Inspired by his brother Stephen’s battle with ALS, Heywood co-founded the company...
Read More →
Speakers
Medical Officer, OSE, CDER, FDA
Sonja Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordination of projects related to the Medical Dictionary for Regulatory Activities...
Read More →CP
Program Lead for Pharmacovigilance, OSE, CDER, FDA
Carol Pamer is Program Lead for Pharmacovigilance in the FDA CDER Office of Surveillance and Epidemiology (OSE) Regulatory Science Staff. She is a Principal Investigator for the FDA-PatientsLikeMe Research Collaboration Agreement. She earned her B.S. degree in Pharmacy from Ohio State...
Read More →
Wednesday June 29, 2016 4:00pm - 5:00pm EDT
113A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 14: Clin Safety/PV,
Session
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Agency Participation, Big Data
- Interest Area Clinical Safety & Pharmacovigilance, Clinical Research
- format json
- Interest Area Clinical Safety & Pharmacovigilance,Clinical Research
- Featured Topics Agency Participation,Big Data
- Credit Type ACPE, CME, IACET, RN
- Tags Session