The drug development process involves a series of lengthy steps that determine the degree of success for every drug brought to the market. Decisions made throughout the process affect every aspect of future development and impact heavily on commercialization strategies.
Included in the course content is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. The course also covers sales planning and the commercialization decisions that affect the development of the drug.
- Basic concepts of drug discovery and testing
- Scientific, regulatory, and management framework for modern pharmaceutical development
- Pre-clinical study requirements and how information gathered is used for human clinical studies
- The four major clinical phases (1-4) in the drug development process and the rationale for each and an introduction to the special problems of each phase
- The economics of drug development
- Cost/benefit issues in clinical development
- Discovery and development milestones
- The IND Process
- The NDA Process
- FDA Interactions – Application review and approval process
- Patents and exclusivity
- The rationale of government regulations and how they effect the development process
- The relationship between the Code of Federal Regulations and ICH GCP
- Designing optimal clinical trials
- Drug labeling, marketing, and pharmacoeconomic studies
- Project management cross functional teams during the development process
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
Designed for employees who need an understanding of the drug development process, this course provides a detailed picture of the complex and highly interrelated activities of the development cycle for drugs and biologics, from discovery to a successful commercialization. The training will be beneficial for anyone involved in the R&D process. It can also be customized for marketing & sales personnel who need to understand that actions taken during the development process have a significant effect on sales and marketing strategies.
Typical attendees include:
- Research & development scientists
- Clinical monitors and research associates
- Medical and clinical investigators and study coordinators
- Physicians & medical liaisons
- Statisticians & data management professionals
- CMC/pharmaceutical research professionals
- Regulatory affairs professionals
- Project managers
- Financial managers
- Brand team personnel
- Senior sales managers
- Strategic planners
A shorter on-site version of this course is available for administrative/support personnel or those new to the life sciences industry who require an understanding of the steps and terminology used in the development process. We can customize the program to meet the specific needs of your personnel.
This course provides an understanding of the interrelated activities throughout the drug development cycle and is designed for R&D, operations and/or marketing and sales management. This course serves as an introduction to the drug development process and will familiarize participants with the steps involved in developing a drug from Discovery to Commercialization. The course is often customized to address specific organizational, departmental or functional issues.
Frequently Asked Questions
Does this course discuss the differences in the drug development process between the US and Europe?
Yes, the similarities and differences between the US and Europe with respect to how medicinal products are developed and approved are discussed in this course.
Do you cover the pre-clinical and clinical study requirements for development?
This course includes an overview of the global regulatory requirements for conducting pre and post clinical studies in the US and EU. The principals of GLP, GCP and GMP are discussed.
Does this course discuss generic medications?
This course discusses the differences between generic and innovator medicinal products as well as the process for submission and approval for marketing.
Does this course discuss the CDP and cross functional teams?
Yes, this course will discuss the importance of preparing and revising an effective CDP and the role of the cross functional teams in executing the CDP.