Clinical Research for Life Sciences Executives
Overview
Biotech and pharmaceutical executives represents a company's interests by leading efforts to develop products within tight budgets and deadlines and ensuring that development efforts remain within expectations set for investors and board members. An understanding of clinical development is critical for effective leadership in these roles. This course will cover the processes of new product development, focusing on clinical research and introduces the essentials of Good Clinical Practice (GCP) and program management.
Who will benefit
This course will be beneficial to life sciences executives new to drug development or executives whose companies will soon have products in development.
Key topics
Advising: Current status of new product development
- Institute of Medicine's recommendation and developments in risk management
- Food and Drug Administration's (FDA) Critical Path Institute and implications for physicians
- Review of regulatory developments across the global community [International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Clinical Trials Directive (CTD), Declaration of Helsinki]
Planning: The executive's role in learning new product development
- Strategic planning for success
- Global development plans
- Targeted product profile development
Overseeing: How the sponsor's responsibilities translate for the executives
- Ethics in recruitment and enrollment
- Investigator Investigational New Drug (IND) applications and compassionate use programs
- Compliance and data quality: regulations, complications and mission of the team
Guiding: Executive as a company leader
- Working with multidisciplinary teams and vendors
- Aligning expectations for better communication
- Understanding the impact of unilateral decisions
Learning outcomes
The objectives of this course are to provide a detailed, executive focused, comprehensive overview of the clinical research process and principles of ICH/GCP, according to industry standards and FDA regulations. Executives who attend will have a better understanding of how they can support the team by providing leadership and guidance that fits into company policies and quality standards.
Learn more about bringing this course in-house.
