This presentation reviews the background and drivers for making the decision – when to outsource pharmacovigilance work. There are several schools of thought on how best to handle safety data as well as who should be involved. Additionally, much has been discussed about the pros and cons to outsourcing and especially off-shoring so that it can be difficult to separate anecdotes from the past from today’s reality. These days much has changed; the key is finding the right partner.
This presentation takes a step-by-step approach to objectively balancing the need to reduce costs with confidence that compliance can safely be maintained and efficiencies gained by utilizing outsourcing models. The most common outsourcing and off-shoring models are discussed in this session in order to provide detailed and practical tips for ensuring that the chosen service provider fits with our company’s needs.
At the conclusion of this workshop, participants should be able to:
- Recognize the challenges Sponsors face with finding solutions to improve efficiencies objectives across multiple internal stakeholders
- Understand different outsourcing and off-shoring models
- Discuss the changing environment and benefits of strategic partnerships
- Describe optimal oversight and techniques for managing at distance
- Apply realistic expectations to the inclusion of “outside staff” in your team
- Describe the key steps in meaningful measurement of quality and performance as it relates to the overall management of product safety
- Understand where to focus in-house resources to support change
Angela Pitwood, Vice President, IPM Safety Services, a division of IndiPharm, Inc.
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 overt-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
IPM Safety Services is a division of IndiPharm, Inc. Our dedicated pharmacovigilance division provides integrated drug safety services to support your clinical research and marketed products. Our senior management team has decades of experience managing and directing large multinational safety and medical information teams, dedicated to processing thousands of adverse events and medical information requests annually. Our focus on process quality provides your organization with high-quality safety processing and reporting – efficiently meeting your expectations and regulatory requirements.
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