19th Pharmacovigilance 2019

19th Pharmacovigilance 2019
“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management”
08th – 10th October 2019, Hotel TBC, Cambridge, Boston, USA
Boston, USA, 2019-Jul-19 — /EPR Network/ — 19th Pharmacovigilance 2019 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. The entire program will cover the detection, analysis and prevention of adverse drug reactions. It will be studied with the help of case studies and industry experiences. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting Pv development.
SPONSORS:
• GOLD SPONSOR: Brookwood, AB Cube, AWINSA Life Sciences
• BRONZE SPONSOR: 4C Pharma Solutions
KEY SPEAKERS:
• DEREK ROY, Resident Agent in Charge, FDA
• BRUNO MENDEZ, VP Global Quality Head Pharmacovigilance, Sanofi
• MARIETTE BOERSTOEL-STREEFLAND, Sr. VP PharmacoVigilance & Drug Safety, Alexion Pharmaceuticals
• COLLEEN WALSH, Senior Director, Pharmacovigilance & Regulatory Quality Management Operations, Alexion Pharmaceuticals
• GERSON PELTZ, Senior Director – Oncology Safety Risk Lead, Pfizer
• SANDRA RAFF, Senior Director, Global Drug Safety and Risk Management, Takeda Pharmaceuticals
• BRUCE DONZANTI, Senior Group Director, Regulatory Pharmacovigilance Policy, Genentech
• WILLIAM WANG, Executive Director, Clinical Safety Statistics, Merck
• MELVIN MUNSAKA, Senior Director, Head Safety Statistics, Abbvie
• XIAO NI, Director, Scientific Computing and Consulting, Novartis
• SHARON REID, Director, Risk Management Product Lead, Pfizer
• WILLIAM BLUMENTALS, Sr. Director, Head of Pharmacoepidemiology, Sanofi Genzyme
• ANNAYA BHATTACHARYA, Global Lead for Safety & Risk Management, Bristol-Myers Squibb
• HARISHA KADALI, Associate Medical Director, Takeda Pharmaceuticals
• JAYLAXMI NALAWADE, Associate Director – Pharmacovigilance and REMS, Lupin
• RICHARD WOLF, Executive Director, Pv Operations, CSL Behring
• PHIL TREGUNNO, Group Manager – Vigilance, Intelligence and Research Group, MHRA (UK)
• STEINAR MADSEN, Medical Director, Norwegian Medicines Agency (UK)
• HEATHER LEIGH FLANNERY, Global Lead, ConsenSys Health
• TOYIN ADEWOLE, Associate Director, Drug Safety – Clinical Research, Supernus Pharmaceuticals
• SANJEEV MIGLANI, Founder and Director, AWINSA Life Sciences
• MUGDHA CHOPRA, Cofounder & Director, AWINSA Life Sciences
• KEVIN TYNAN, Consultant, Global Clinical Safety and Pharmacovigilance, CSL Behring
• ISRAEL GUTIERREZ, VP Pharmacovigilance & Drug Safety, Geron Corporation
• SHEETAL KHEDAR, Senior Director, Regulatory Science, Sarah Cannon Development Innovations
• DAVID HUTCHINSON, Founder, Brookwood International Academy
• MELVA COVINGTON, Senior Principal, AGAPE Strategic Solutions
• BEN LOCWIN, Senior Vice President, Quality, Lumicell
Plus many more
KEY THEMES DISCUSSED IN THIS CONFERENCE:
• Pharmacovigilance in the US: What comes next for the industry?
• Recent developments – legislation, policies, systems, technology, communication strategies and best practice in PV
• Challenges and Opportunities for Effective Pharmacovigilance in the 21st Century
• Why does pharmacovigilance sometimes fail and where
could the fault lie?
• Pharmacovigilance and healthcare system
• Future of Signal Detection – Growing companies and safety efficiencies
• Technology Impact – Cloud – Big data – Analytics – AI – Machine learning
• Good Clinical Practices and Good Pharmacovigilance practices
• Future of outsourced phase I, II and III trials and post-marketing studies,
• Data quality management and analysis – analyzing the new guidelines
• Strategies to improve clinical trials and PV
• Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
• Patient centric approach to help improve patient safety
• Outsourcing activities – Choosing your right vendor and setting the path right
• PV Audit & inspections – preparation, implementation and lessons to be learnt
• Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models
• Current regulations and guidelines – USA, EU and RoW
• The developing regulatory framework in advanced and developing markets
• Be part of a major networking opportunity
WHO SHOULD ATTEND:
CEO’s, CTO’s, CIO’s, Presidents, VPs, Directors, Heads, Managers, Scientific Advisors, Consultants of:
Pharmacovigilance, Pharmacoepidemiology, Pharmacogenomics, Drug/Product Safety, Drug Development, Information and Clinical Data Management, Clinical Pharmacology, Clinical Safety, Periodical safety update Reports, Risk Management, Research & Development, Quality Assurance, Patient Safety, Signal Detection, Safety Surveillance, Outcomes Research, Data Analysis, Epidemiology, Medical Affairs, Regulatory Affairs and Compliance, Information technology, Sales and Marketing
CONFERENCE SPONSORSHIP:
E-mail – kavitha@virtueinsight.co.in or Tel: +44 2036120886
Sponsor, Exhibition Stall (Booth) and a paid Speaker Slots are also available.
We also have some sponsorship opportunities available for the event, which gives you an opportunity to sponsor/speak/exhibit, and create brand awareness. In addition, the networking opportunities in focused and relevant industry gathering provide the personal contact necessary for business development efforts.

CONFERENCE REGISTERATION:
In order to register contact us on Email: kavitha@virtueinsight.co.in Tel: +44 2036120886
Conference Only:
• Introductory Offer (3 delegate places for the price of 2) A huge saving (Limited seats left)
• Early Discount (25th June 2019 – 19th August 2019): (£1299 per delegate)
• Standard Registration (20th August 2019 Onwards): (£1499 per delegate)
Conference + Workshop:
• Introductory Offer (3 delegate places for the price of 2) A huge saving – (Limited seats left)
• Early Discount (25th June 2019 – 19th August 201): (£1499 per delegate)
• Standard Registration (20th August 2019 Onwards): (£1699 per delegate)
Workshop Oniy – £399
Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway. Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margins. Expand your knowledge of the latest business models and strategies in the high-level conference.