Ensuring Pharmacovigilance Compliance and Robust Oversight at the Affiliate Level

Life Sciences, Pharmaceutical, Drug Safety, Commercialization & HEOR,
  • Tuesday, September 08, 2020 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

Due to harmonisation of pharmacovigilance regulations and globalisation, the role of an affiliate has shifted to be a dual role – driving commercial growth along with pharmacovigilance management. At the same time pharmacovigilance has become more complex and operations associated with regulatory and pharmacovigilance activities is an unwanted burden to the affiliate.

Join us to explore the challenges associated with managing pharmacovigilance at an affiliate level, potential solutions and explore the benefits of adopting an outsourced model.

Speakers

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Sharlene Ahmed, Drug Safety Manager, Pharmacovigilance and Safety Services, ICON

Sharlene Ahmed is a Drug Safety Manager at ICON with over four years of experience in Pharmacovigilance, including the management of global affiliate services for Pharmacovigilance across 75 countries. Ahmed also acts as Subject Matter Expert (SME) in this area, serving as Local Responsible Person for UK and Ireland. During studies at the University of Nottingham in Biochemistry, Ahmed also took part in a pharmacovigilance and medical information internship. Once graduating in 2014, she worked in the Health App and Technology industry before returning to pharmacovigilance in 2015.

Message Presenter
http://Barry%20Rice,%20ICON

Barry Rice, Director Project Management, Pharmacovigilance and Safety Services, ICON

Barry Rice has over 23 years of clinical research experience (20 years with ICON) and has worked in various Project Management roles including post-marketing. He has worked for over three years in the development of the global Affiliate model solution for Pharmacovigilance. He received his BSc Honors Degree in Pharmacology from the University of Liverpool, holds a Master’s Degree in Biotechnology from the Nottingham Trent University and a Postgraduate Certificate in International Business Management, Smurfit Graduate Business School, University College Dublin.

Message Presenter

Who Should Attend?

Vice Presidents, Executives, Directors, Managers and Associates responsible for oversight, ideally with approved products in remote territory. Most receptive clients will be mid-sized:

  • Outsourcing
  • Procurement
  • Quality Assurance
  • Project Management
  • Pharmacovigilance
  • Medical Affairs
  • Regulatory Affairs
  • Post Market
  • Clinical Trials Phase 2b onwards

Xtalks Partner

ICON 

ICON plc is a global provider of outsourced development and commercialization services to pharmaceutical, biotechnology, medical device and government and public health organisations. The company specializes in the strategic development, management and analysis of programs that support clinical development. With headquarters in Dublin, Ireland, ICON currently operates from 98 locations in 40 countries and has approximately 15,100 employees. Further information is available at ICONplc.com.

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