Center for Professional Innovation & Education, Inc., Malvern, PA
May 2 - 4, 2016
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.
Michael A. Pierro is consultant to life sciences industries; building on over 35 years of pharmaceutical-industry experience to provide services in clinical-practice areas of SOPs, study management and monitoring, auditing and site qualification.
Mr. Pierro previously served as Director of Business Development, Consulting and Clinical Training for a large consulting firm. There, he was responsible for the development and implementation of SOPs, specialized training programs and related consulting services. His clients included pharmaceutical and biotechnology firms, CROs, university medical centers and the United States government.
Before this, Mr. Pierro was Director of Global Training for the Global Clinical Quality Assurance Department of Hoechst Marion Roussel (now Aventis). In this role, he directed all GCP, SOP and technical training activities within the company's Drug Development Center and other sites throughout the world. In his other roles at the company; he served as a Senior CRA, Manager of Phase-IV Clinical Operations, Chairperson of the SOP Steering Committee and GCP Auditor. In addition, Mr. Pierro was involved in several NDA/SNDA preparations, filings and other reports to regulatory agencies.