15th Annual 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 quality research organisations 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 pharmacovigilance requirements, and to improve their organisation’s compliance with pharmacovigilance requirements.
KEY SPEAKERS:
VICKI R EDWARDS, Vice President, Pharmacovigilance Excellence and QPPV, Abbvie
KARSTEN LOLLIKE, Corporate Vice President and QPPV, Novo Nordisk
KHAUDEJA BANO, Senior Medical Director Medical Affairs, Abbott (USA)
RENE HALTINER, Managing Director / Senior PV Strategy Lead, Conceptual Process Solutions / F. Hoffmann-La Roche
JOHN SOLOMON, Head of Pharmacovigilance - UK & Ireland, Sanofi
YUUNG YUUNG YAP, Senior International Regulatory Counsel, EU and International Regulatory Law, Pfizer
DAVID J LEWIS, Senior Adviser Pharmacovigilance, Novartis
TANJA PETERS, Global Head of PV Intelligence, Deputy EU QPPV, Boehringer Ingelheim
MICHAEL BEAN, Senior Director, Regulatory Compliance R&D, Janssen Pharmaceutical
SUSAN WELSH, Chief Safety Officer, CSL Behring (USA)
HELEN MCASKILL, Interim Head of Research and Development at Department of Health, Isle of Man Government
FRANCK SCHWARTZ, QA Global Inspection, Intelligence Lead - Compliance and Regulatory Affairs, Novartis
RICARDA TIEMEYER, Head of Drug Safety & PoC Medical Information, Roche
MICHAEL RICHARDSON, VP International GPV&E and EU QPPV, Bristol-Myers Squibb
RUDI SCHEERLINCK, Head Global Drug Safety, Basilea Pharmaceuticals
SUMIT MUNJAL, Global Director, Pharmacovigilance & EU Region Medical Advisor - Lead Oncology Portfolio, Takeda Pharmaceuticals
MICK FOY, Group Manager, Vigilance Intelligence and Research Group Vigilance and Risk Management, MHRA
ULRICH VOGEL, Head Strategic Data Analysis, Global Pharmacovigilance, Boehringer Ingelheim
JACKIE ROBERTS, Executive Director Regulatory, Pharmacovigilance and Medical, Accord Healthcare
STEINAR MADSEN, Medical Director, Norweigen Medicines Agency
PHILIP EICHORN, Senior Director (Worldwide Safety and Regulatory), Pfizer
HEINZ WEIDENTHALER, Director Pharmacovigilance, QPPV, Bavarian Nordic
KATHRIN WAWRA-HEHENBERGER, Director, Clinical Safety Physician, CSL Behring
MIRCEA CIUCA, Global Head Medical & Clinical Drug Safety, Vifor Pharma
KAREN CHENG, Safety Risk Lead, Pfizer
MODESTAS JARUTIS, Medical Manager, Roche
G. NARAYANAN, Vice President, Disruptive Biologics, Voisin Consulting Life Sciences
JORGE GONZALEZ BORROTO, Pharmacovigilance Officer / Nonclinical Toxicology Expert, Ferrer Internacional
ANDREA MAULWURF, Head of Pharmacovigilance, EU-QPPV, Allergy Therapeutics
DAVID JEFFERYS, Sr. VP Regulatory, Eisai
CHETAN SHATAPATHY, Director, Sanjeevani Pharma
SANDY EISEN, Chief Medical Officer, Frontline Pharma Consulting
HILARY JONES, Of Counsel, Bristows
Plus many more
KEY THEMES:
Pharmacovigilance in 2020 - future horizons and efficiencies
Updates towards of legislation, policies, systems, technology, communication strategies and best practice in PV
Possible effects of Brexit on Pharmacovigilance
Strategies for best practice in bene t-risk management
Market analysis – What is our current stand? – Moving towards the new successful PV era
Implementing risk minimization procedures - Making sure we succeed
Examining developments in GVP measures and status of the new Module VI
Improving in signal management and their implications
Safety information
Medical devices
Good Clinical Practices and Good Pharmacovigilance practices
IT and new technologies for improvement of PV and clinical research
Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
Patient centric approach to help improve patient safety
Outsourcing activities
PV Audit & inspections
Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models
Accelerating new medicine introduction in developing world & overcoming challenges
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 BOOKING DETAILS:
E-mail: [email protected] or TEL: +44 2036120886
Introductory Offer: 3 delegate places for the price of 2
Standard Registration: (£1150 + VAT per delegate)
Conference Sponsor & Exhibition Stall and paid Speaker Slots are also available.
15th Pharmacovigilance conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting pharmacovigilance development.