This presentation reviews some of the elements that go into decision making for outsourcing pharmacovigilance work especially for off shore projects. The speaker will discuss the important elements that constitute successful pharmacovigilance outsourcing projects and describe how to “crack the code” of assuring themselves that the targeted return on investment can be achieved without sacrificing quality?
This presentation takes a step-by-step approach to review:
- The perceptions of industry today with respect to pharmacovigilance
- The expectations Sponsor companies have of what outsourcing is and what it is not
- What are reasonable cost savings to expect
- What are the important factors that allow companies to crack the elusive code to achieve cost effectiveness without compromising quality during a pharmacovigilance study?
At the conclusion of this workshop, participants should be able to:
- Understand different outsourcing and off-shoring models and describe realistic expectations of both
- Balance the need to find cost effective pharmacovigilance solutions with need to perform within regulatory mandates
- Understand the keys to successful relationships with outsourcing partners and their staff
- Provide internal stakeholders e.g. contracts groups or procurement staff with an understanding of the important quality elements that are required when outsourcing pharmacovigilance activities
Angela Pitwood, Vice President, IPM Safety Services
Angela Pitwood is the Vice President of Pharmacovigilance for IPM Safety Services. Angela is responsible for the ongoing development and management of IPM Safety Services operations. With over 20 years of experience in the Pharmaceutical industry, Angela offers her clients the assurance that their drug safety programs are being managed by a seasoned pharmacovigilance executive with experience in developing, implementing and leading safety operations in lower cost markets.
Angela was formerly Vice President of Drug Safety Surveillance at Pfizer, Inc., where she successfully developed and led 12 therapeutic area teams and support functions for the management of adverse event reporting for human health, including all phases of a product life cycle (drugs, vaccines and devices). Angela led these activities using a combination model of 360 in-house staff at three global locations – U.S., Europe and Asia. In addition, she developed and managed three off-shored safety processing vendor sites in India, as well as outsourced groups in the United States.
Who Should Attend?
This workshop is for pharmacovigilance professionals in pharmaceutical, biotech, generics as well as safety professionals in medical device, vaccines and over-the-counter products involved in leading operational activities, assessing productivity and evaluating efficiencies.
Specific roles may include:
- Drug Safety operations
- Clinical Research and Development
- Pharmacovigilance Operations
- Risk Management
- Medical Writing
- Medical Information
- Project Management
IPM Safety Services provides pharmacovigilance and risk management services for clinical research and marketed products.