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, Sr. 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:
In order to register you can simply let us know your interests through Email: [email protected] or CALL: +44 2036120886
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 Sponsor & Exhibition Stall (Booth) or a paid Speaker slots are also available
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)
Conference Sponsor & Exhibition Stall (Booth) or a paid Speaker slots are also available
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.