16th Pharmacovigilance 2018

16th Pharmacovigilance 2018

“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management"

02nd – 04th Oct 2018, Double Tree Suites By Hilton Boston, Cambridge, Massachusetts, USA

16th Pharmacovigilance 2018 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. This conference will help the drug safety representatives from the pharmaceutical industry and academic and quality research organizations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing pv requirements, and to improve their organizations' compliance with pv requirements. Also it can help you control your product's lifecycle, your patient's trust, and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting Pv development.

SPONSORS:

• PRINCIPAL SPONSOR:

• Brookwood

KEY SPEAKERS:

• WILLIAM WANG, Executive Director, Clinical Safety Statistics, Merck
• TEGINDER SINGH, Senior Director Global Regulatory Affairs, Johnson & Johnson
• ALEXANDRE KIAZAND, Global Head Safety Science, AstraZeneca
• RICHARD WOLF, Head of GCSP Regions & PV Operations, CSL Behring
• MICK FOY, Group Manager, MHRA (UK)
• DEEPA ARORA, Vice President - Pharmacovigilance & Global Head- Drug Safety & Risk Management, Lupin
• KHAUDEJA BANO, Senior Medical Director Medical Affairs, Abbott
• DOUG COFFMAN, Chief of Staff/Senior Director, Strategy & Business Planning - Global Patient Safety Evaluation, Takeda Pharmaceuticals
• MATTHEW MELDORF, Senior Group Medical Director, Safety Science, Genentech
• ANAND ANANTHAKRISHNAN, Director, Pharmacovigilance Safety System Operations, Fresenius Medical Centre
• WILLIAM BLUMENTALS, Director, Pharmacoepidemiology Team Lead, Sanofi Genzyme
• PEDRO L. OYUELA, Medical Director, Global Patient Safety, Amgen
• ANNAYA BHATTACHARYA, Director Global IO Implementation Lead, Bristol-Myers Squibb
• DAVID CHONZI, Vice President- Head of Patient Safety and Pharmacovigilance, Kite Pharma, A Gilead Company
• ANKA G. EHRHARDT, Director, Clinical Research, CHDI Foundation
• DAVID HUTCHINSON, Founder, Brookwood International Academy
• SUZANNE SCHRANDT, Director, Patient Engagement, Arthritis Foundation
• MELVA T. COVINGTON, Principal, AGAPE Strategic Solutions
• SHEILA WEISS, Senior Research Leader, Evidera
• SHEETAL KHEDKAR, Senior Director, Regulatory Science, Sarah Cannon Development Innovations
• BEN LOCWIN, President, Healthcare Science Advisors
• STEPHEN F. AMATO, Faculty Director Graduate Regulatory Affairs, Market Access and Life Sciences, Northeastern University

Plus many more

KEY THEMES:

• Pharmacovigilance in the US: What comes next for the industry?
• Recent developments - legislation, policies, systems, technology, communication strategies and best practice in PV
• Optimising the overall PV ecosystem - Challenges and Opportunities
• Why does pharmacovigilance sometimes fail and where
could the fault lie?
• Pharmacovigilance and healthcare system
• Technology Impact - Cloud – Big data – Analytics – AI – Machine learning
• Updates to PSUR, PBRERs, DSUR, PASS
• 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 REGISTERATION:

Conference + Workshop:

• Introductory Offer (3 delegate places for the price of 2) A huge saving of £999 - (Limited seats left)
• Super Early Discount (Valid Till 5th July 2018) : (£999 per delegate)
• Early Discount (6th July 2018 - 17th August 2018): (£1299 per delegate)
• Standard Registration (18th August 2018 Onwards): (£1499 per delegate)

Conference Only:

• Introductory Offer (3 delegate places for the price of 2) A huge saving of £799 (Limited seats left)
• Super Early Discount (Valid Till 5th July 2018: (£799 per delegate)
• Early Discount (6th July 2018 - 17th August 2018): (£999 per delegate)
• Standard Registration (18th August 2018 Onwards): (£1299 per delegate)

Workshop Oniy - 250

Join us at 16th Pharmacovigilance 2018 and expand your knowledge of the latest business models and strategies in the high-level conference. 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.