8th pharmacovigilance 2015
TRANSCRIPT
8th Pharmacovigilance 2015
“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management"
24th & 25th February 2015, Marriott Marble Arch Hotel, London, UK
For more info on the event and for event brochure kindly visit –http://www.virtueinsight.com/pharma/8th-Pharmacovigilance-2015/
Contact :- Nisha:- +917401150416. Email – [email protected]
Key Themes Discussed at this Summit:• Update yourself with respect to terms of legislation, policies, systems, technology,
communication strategies and best practice in PV• Developing Pharmacovigilance into high quality management system and its
components• Audit and Inspection: Realistic steps for a fruitful consequence• EMA PSMF - Assuring compliance and provide standardization• Discover approaches for collecting, integrating and analyzing all of the safety data
generated from preclinical models• Exploiting the pharmacy automations and technologies for enhancement of
medication safety• Developments in Pharmacovigilance, drug safety & risk management to ensure safer
drugs to market• Improving patient care and safety in relation to use of medicines and all medical and
paramedical interventions• Determining the steps and strategies for enhancing quality in healthcare• Emerging signal detection data gathering successful tools to highlight emerging risks• IT solutions for Pharmacovigilance – Learn & Explore• Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients• GVP Module V and XVI – explaining authority expectations and avoid speculation and
differing interpretation of the current guidelines• Review the use of (PSURs) post-authorisation for safety signals • ICH-R3 standards - Determining where future challenges could arise• The developing regulatory framework in advanced and developing markets• Accelerating new medicine introduction in developing world & overcoming challenges• Explaining how to use the data sources and observational research for effective safety
analysis• Be part of a major networking opportunity
Key Speakers: • Michael Richardson, VP International & QPPV EU GPV&E, Bristol Myers Squibb• Kathy Williams, Lead Pharmacovigilance & Regulatory Excellence, GRAPSQA,
AstraZeneca• William Gregory, Director - Safety & Risk Management, Pfizer (USA)• Michael Bean, Senior Director, Regulatory Compliance R&D at Janssen, Johnson &
Johnson• Franck Schwartz, Senior Director, Safety & Compliance, Novartis• Catherine Akers, Regulatory Affairs Manager – EU Policy, Amgen• John Parkinson, Consultant Expert, Healthcare Data (Former Director CPRD, MHRA)• Sumit Munjal, Global Director, Pharmacovigilance & EU Region Medical Advisor - Lead
Oncology Portfolio, Takeda Pharmaceuticals• Deborah Layton, Principal Research Fellow, Drug Safety Research Unit (DSRU)• Brian Edwards, Principal Consultant, Pharmacovigilance & Drug Safety, NDA• David Jefferys, Sr. VP Regulatory, Eisai Pharmaceuticals• Barbara Dawson, Vice President - EU QPPV, The Medicines Company
• Nele Matthijs, PhV Inspector, DG Inspection, Federal Agency for Medicines and Health Products
• Steinar Madsen, Medical Director, Norweigen Medicines Agency• Pipasha Biswas, Director, Symogen• Veronique Basch, Executive Director, Global Pharmacovigilance, UBC• Veronica Fjellström, Deputy QPPV, Bluefish Pharmaceuticals• Fiona Maini, Sr. Manager, Deloitte Consulting• Gillian P Lennard, Director of Regulatory Affairs, European Regulatory Solutions
Plus Many More...
Target Audiance-Industry:-
• Pharmaceutical organisations• Generic pharmaceutical companies• Contract research organisations • Patient recruitment companies • Government- Department of health• Non-profit organisations/ Association• Consultans
Conference Booking Details:
Introductory Offer (3 delegate places for the price of 2):- A huge saving of £ 600 - (Limited seats left)
Super Early Discount (Till 12th December 2014):- Conference Delegate Pass (£ 600 + VAT per delegate)
Early Discount (13th December 2014 - 16th January 2015):- Conference Delegate Pass (£ 800 + VAT per delegate)
Standard Registration (17th January 2015):- Conference Delegate Pass (£ 1100 + VAT per delegate)
To register or for more details please contact :- Nisha :- +91 7401150416. Email – [email protected]
We also have sponsorship opportunities available for the event which gives you an opportunity to 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.
Should you or any of your colleagues be interested in participating, please let me know and I would be glad assist you accordingly.
Thank you for your time and consideration.
Regards,Nisha