Patient-centered outcomes (PCO) research is crucial to successful product development in the pharmaceutical/biotechnology industry. PCO research scientists seeking to pursue a career aligned with this industry should understand the product development process, the product lifecycle, the scientific communication process and interactions with key industry stakeholders – both internal and external (i.e., regulators and payers).
This training is aimed at individuals who are:
- Pursuing a PCO research career
- New to the pharma/biotech industry
- Looking to gain a better understanding of PCO research-related activities within the pharma/biotech industry (e.g., may currently be working in a medical affairs team)
- Pursuing a career that works closely with the pharma/biotech industry (e.g., regulatory authorities, payer/health technology appraisal organizations, consulting companies)
- Mentors in academia who help students make career decisions
- Discuss the different stages of drug development.
- Discuss the pharma/biotech product lifecycle and PCO research needs associated with different stages.
- Review the roles, responsibilities and scientific deliverables of a PCO research scientist in the pharma/biotech industry.
- Develop awareness of different functions in the pharma/biotech industry that are key internal stakeholders in the drug development process and partners for PCO research scientists.
- Define key PCO research industry terms, business deliverables and related responsibilities.
- Discuss types of regulatory interactions that may involve PCO research and the preparation process for regulatory interactions, with a focus on FDA and EMA.
- Discuss market access considerations for PCO research.
- Understand PCO research communications and the importance of outreach to various audiences, including patients and physicians.
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