Trk 14: Clin Safety-PV [
clear filter]
8:30am EDT
#117: IDMP: A Compliance Project or a New Way of Conducting Business?
Chair
Principal Consultant, NNIT A/S
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more...
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Speakers
Regulatory Affairs SME, NNIT Inc.
Debbie Persaud is a RA SME at NNIT US. Prior to joining NNIT, she worked as a RA Manager at Pfizer and Ethicon specializing in global regulatory submission strategies for biologics and medical devices. She has a MSc. in Biomedical Sciences from the University of Medicine and Dentistry...
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Monday June 27, 2016 8:30am - 9:30am EDT
109AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
8:30am EDT
#116: Has the EU Good Pharmacovigilance Practices Delivered on Its Intended Promise and Commitment?
Chair
EU QPPV, Global Patient Safety, Eli Lilly and Company Ltd
Dr. Simmons is currently the EU QPPV for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focussed her career drug safety through senior management positions in Glaxo Eli Lilly. Val...
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Speakers
Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of...
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General Manager, Dr. Ebeling & Assoc. GmbH
Dr. Leonardo Ebeling, general manager and co-founder of Dr. Ebeling & Assoc., located in Hamburg, Germany. He studied medicine at the universities of Marburg and Hamburg. After completing his studies in 1984, he worked for big and medium-sized pharmaceutical companies in leading positions...
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Monday June 27, 2016 8:30am - 9:45am EDT
103C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:45am EDT
#140: Understanding, Developing, and Implementing an Anticipated Events Review Process: Adoption of the FDA IND Rule on Safety Reporting Requirements
Chair
Associate Director, Biostatistics, Janssen Research & Development, LLC
Mac received a Masters in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology. He has been involved in pharmacovigilance, signal detection and data visualization for most of his career, including membership in several multi-disciplinary...
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Speakers
Senior Medical Advisor, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology...
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Advisor, Expedited Reporting Global Patient Safety, Eli Lilly and Company
18 years of pharmaceutical drug safety experience. Currently oversees global PV expedited reporting business processes. She supported multiple projects including the FDA IND rule changes, database updates, creation of an investigator line listing report, & EU GVP process updates...
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Monday June 27, 2016 10:45am - 12:00pm EDT
108A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:30am EDT
#323: Social Listening for Pharmacovigilance: Practical Considerations and Challenges for Implementation
Chair
Safety Evaluation and Risk Management Scientist, GlaxoSmithKline
Manager-Safety Evaluation and Risk Management Laurie joined GlaxoSmithKline in 2009 as a Medical Information Scientist. Prior to GSK Laurie worked as a clinical pharmacist at The University of California-San Francisco Medical Center and Duke University Medical Center. She earned her...
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Speakers
President and Senior Medical Advisor, Medical and Pharma Advisors Group
Lalitha is a board certified physician with subspecialty training in Internal Medicine with 14 +years in clinical practice & over 15 years in the Pharmaceutical Industry. She runs an independent consultancy practice. Previously she worked in Ardea BioSciences as Head of Pharmacovigilance...
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Managing Partner, Fathom Digital Healthcare Consulting
20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to...
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Director, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline
Lorrie is Director, Safety Evaluation and Risk Management at GSK. She has more than 16 years experience in the pharmaceutical industry. Dr. Schifano obtained a B.S. in Pharmacy at Duquesne University in Pittsburgh, PA and her Pharm.D. at University of North Carolina, Chapel Hill...
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Wednesday June 29, 2016 10:30am - 11:45am 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 Basic
- Featured Topics Program Offerings for Student Attendees, Social Media Strategies, Big Data
- Interest Area Clinical Safety & Pharmacovigilance
- format json
- Interest Area Clinical Safety & Pharmacovigilance
- Featured Topics Program Offerings for Student Attendees,Social Media Strategies,Big Data
- Credit Type ACPE, CME, IACET, RN
- Tags Session
2:00pm EDT
#349: Measuring the Effectiveness of Risk Minimization: Principles and Regional Requirements
Chair
Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of...
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Speakers
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...
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Director of Risk Management Epidemiology, Oxon Epidemiology
Annalisa Rubino is Director of Risk Management Epidemiology with OXON Epidemiology. She is a Pharmacoepidemiologist with extensive research experience in drug development in academia and industry. She has worked in consultancy for the pharmaceutical industry in therapeutic risk management...
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Wednesday June 29, 2016 2:00pm - 3:15pm EDT
109AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
4:00pm EDT
#373: Safety Reporting Pitfalls and Successes for Oncology and Hematology Drugs
Chair
Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER, FDA
Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including...
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Speakers
Deputy Director, Regulatory Science, OSE, CDER, FDA
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality...
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Therapeutic Area Lead, Clinical Safety and Risk Management, Oncology, and Bone, Merck Research Laboratories
Nina Stuccio, D.O. is the Therapeutic Area Lead, Oncology and Bone, Global Safety and an Industry member of the Clinical Trial Transformation Initiative (CTTI) IND Safety Advancement Project, focused on oncology trials to determine barriers and identify solutions for compliance with...
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Wednesday June 29, 2016 4:00pm - 5:15pm EDT
113B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:45am EDT
#410: The Role of Big Data in Transforming the Detection of Adverse Drug Reactions
Chair
Senior Research Scientist, Oracle Health Sciences
Rave Harpaz is a Senior Research Scientist at Oracle Health Sciences. Previously, Rave was a Research Scientist at Stanford University, a post-doctoral fellow at Columbia University, and a quantitative risk modeling analyst at Merrill Lynch. Rave holds a PhD in Computer Science from...
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Speakers GG
Associate Professor, Department of Biomedical Informatics, Arizona State University
Head, Signal Management Group, Janssen Pharmaceuticals, Inc.
Amy is an experienced pharmacovigilance physician, focusing on proactive surveillance. She has been in industry for 15 years and at JNJ for the last 12. She is currently the lead of the Signal Management Group, which is dedicated to the development and implementation of new signal...
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Medical Officer, Office of Translational Sciences, CDER, FDA
Dr. Alfred Sorbello is a Medical Officer at FDA in the Office of Translational Sciences of the Center for Drug Evaluation and Research (CDER). Previously, he worked in CDER’s Office of Surveillance and Epidemiology /Division of Pharmacovigilance II and in CDER’s Office of New...
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Thursday June 30, 2016 10:45am - 12:00pm EDT
113B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA