Adverse events are the pillars of pharmacovigilance and safety operations as we know them. They are the drivers for developing safety databases, risk management plans, risk evaluation and mitigation strategies, benefit-risk assessments, and periodic reports. Their collection and reporting are instrumental in leading to preventative actions for marketing better and safer drugs.
The
4th Adverse Event Reporting and Safety Strategies Summit illuminates and disseminates best practices in pharmacovigilance and
adverse events management. Attendees will explore lessons learned and replicate best practices of our illustrious speaking faculty of regulators and industry-leading practitioners, and other experts.
The pharmacovigilance space is constantly evolving - as are the needs of professionals and stakeholders in this area. In order to promote patient safety, proactively monitor adverse events and understand their impact in every phase of development, it is crucial to keep up to date with the latest regulatory changes, innovations and emerging technologies.
This summit is expressly designed for PV professionals and stakeholders seeking to ensure global compliance and improve their company's effectiveness in
adverse events reporting, drug safety management and risk mitigation. The summit disseminates best practices of life sciences companies to detect and prevent adverse reactions that positively impact drug safety profiles by illuminating tactics for related to benefit-risk assessment, real-world data solutions and analyses, signal detection, periodic reporting and solicited/unsolicited reports.
Top Five Reasons to Attend
- Harmonize PV globally in compliance with the disparate expectations and timelines of regulatory authorities
- Prepare comprehensive reports by optimizing signal detection in enhancing data collection and mining methods
- Improve safety through robust safety governance and internal audits of risk management efficiency assessments
- Execute tactics and leveraging tools for measuring risk management efficiency to better identify potential and prevent adverse events
- Vet emerging technologies, solutions and partner strategies to streamline global safety operations and reporting
Speakers
- Deepa Arora, Vice President, Pharmacovigilance and Global Head, Drug Safety and Risk Management, LUPIN LIMITED
- Paul Beninger, Assistant Professor of Public Health and Community Medicine, TUFTS UNIVERSITY SCHOOL OF MEDICINE, Former Vice President, Global Patient Safety, GENZYME
- Deanna Montes de Oca, Associate Director, PV Operations Clinical Safety and Pharmacovigilance, OTSUKA
- Michael von Forstner, Co-Chair, Pharmacovigilance Working Group, MEDICINES FOR EUROPE
- Stephen A. Goldman, Managing Member, STEPHEN A. GOLDMAN CONSULTING SERVICES, Former Medical Director, MEDWATCH, U.S. FOOD AND DRUG ADMINISTRATION
- Andres Gomez, Vice President, Head of Epidemiology, Safety Science and Analytics, BRISTOL-MYERS SQUIBB
- Joanne Grego, Global Vendor Management and ICSR Quality Lead, GCSP, CSL BEHRING
- Israel Gutierrez, Senior Director Drug Safety and Pharmacovigilance, PHARMACYCLICS
- Bill Haddock, Head of Safety, OVID THERAPEUTICS
- Ghazala Haque, Safety Surveillance Manager, DUKE UNIVERSITY MEDICAL CENTER
- Judith Sills, Vice President and Head, Global Pharmacovigilance, THE MEDICINES COMPANY
- Gay Steinbrick, Director, Global Clinical Safety and Pharmacovigilance, MERCK
- Sameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS UNIVERSITY
- Susan Welsh, Chief Safety Officer, CSL BEHRING
- Richard Wolf, Head, GCSP Regions and Pv Operations, CSL BEHRING
Please fill in your name and email to receive the conference agenda of this event.
Conference Day One - Monday, December 4, 2017
Conference Day Two - Tuesday, December 4, 2017
The agenda is available as PDF under downloads at the right side of the page.
Venue
Sonesta Philadelphia Downtown Rittenhouse Square
1800 Market St, 19103
Philadelphia, PA, USA
Who Should Attend
This conference is designed for professionals from pharmaceutical, biotech and medical device companies with responsibilities in the following areas:
- Pharmacovigilance
- Drug Safety
- Risk Management
- Safety Research/Epidemiology
- Pharmacoepidemiology
- Medical Product Safety Assessment
- Regulatory Affairs
- Clinical Research
- Safety Surveillance
- Signal Detection
- Clinical Safety
- Patient/Medical Safety
- Health Outcomes
- Phase IV/Postmarketing Safety
This conference is also of interest to:
- Adverse Event/Case Management Service Providers
- Safety Database Providers for Case Management
- CROs
- PV Services Providers and Consultants
- Healthcare/Pharmacovigilance Consultants
- Healthcare Translation Agencies
- Technology Vendors/Portal Service Providers
Venue
Sonesta Philadelphia Rittenhouse Square1800 Market Street
Philadelphia, PA 19103
Explore the comfort and fresh, contemporary vibe at the all-new Sonesta Philadelphia. A premier choice among hotels in Philadelphia enjoys spacious, modern accommodations and luxurious amenities while staying in the heart of downtown and only steps away from Rittenhouse Square.
Relax and retreat in spacious accommodations. Treat yourself to a tasty bite, cocktails, and people watching at ArtBar. Go for a swim or lounge with a drink at our seasonal rooftop pool. Or wander through our gallery featuring the finest local artists around the city. Casual sophistication, impeccable service, and delightful added touches are what set us apart from Philadelphia Rittenhouse Square hotels.
To make reservations please call 1-800-SONESTA and request the negotiated rate for ExL’s December Meetings. Tso make reservations online
Click HereThe group rate is available until November 14, 2017. Please book your room early as rooms available at this rate are limited.
