- To view our U.S. Pharmaceutical Development and Regulatory Systems Workshop brochure contact us online or at 913.451.3955
Our clients consider us an outstanding educational resource for worldwide drug development. Projects are often placed with our company, not only for business reasons, but also as an educational investment for future projects.
Four representative workshops are provided below. The primary objective of these workshops is to provide the participants and their companies with the opportunity to benefit from the experience of Beckloff Associates in the pharmaceutical industry. Customized workshops are also available upon request.
- U.S. Pharmaceutical Development and Regulatory Systems (4 weeks)
- Quality and CGMP Workshop: U.S. General Regulatory Systems and Current Good Manufacturing Practices (3-5 days)
- Scientific and Regulatory Affairs Workshop: U.S. General Regulatory Systems and Investigational New Drug (IND) Application (2-3 days)
- Scientific and Regulatory Affairs Workshop: U.S. General Regulatory Systems and New Drug Application (NDA) (2-3 days)
U.S. Pharmaceutical Development / Regulatory Workshop
Beckloff Associates provides a wide range of consulting services used to obtain marketing approval for drugs, biologics, and medical devices in the U.S., Canadian and European markets. Our goal is to help biotechnology, pharmaceutical and medical device customers increase the financial return on their research investments through the design and implementation of efficient global scientific and regulatory strategies.
To assist companies in developing a better understanding of the scientific and regulatory aspects of worldwide drug development, we have developed an intensive, "hands-on" educational program. This program is designed to provide direction and insight into the U.S. drug development infrastructure, as well as demonstrate the interrelationship of FDA regulations with ICH guidelines.
The workshop is an intensive four-week training program consisting of 120 hours of lectures and discussions led by professionals in their representative fields.
For reference, participants will be provided with annotated Drug Master Files (DMFs), Investigational New Drug (IND) Applications, protocols for Phase I and II clinical trials, and other relevant documents required for submission to U.S. regulatory agencies. These documents will be studied and reviewed thoroughly with the participants during the Workshop sessions. As the lectures and discussions revolve around these specific reference documents, opportunities will be available to thoroughly discuss Current Good Manufacturing Practices (CGMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs). Requirements for updating various Food and Drug Administration (FDA) submissions and preparing and submitting Annual Reports will be addressed. The initiation and monitoring of U.S. multicenter clinical trials and reporting adverse reactions will also be outlined, and lectures will also be presented on the health insurance system in the U.S.
Major topics of the U.S. Pharmaceutical Development and Regulatory Systems Workshop:
- U.S. Laws and Regulations/Federal Agencies
- Strategic Worldwide Drug Development
- Current Good Manufacturing Practices (CGMPs)
- Preclinical Studies and Good Laboratory Practices (GLPs)
- Drug Master Files in CTD format
- Investigational New Drug (IND) Applications
- Clinical Development
- New Drug Applications (NDA)