Mastering Clinical Research: Training Program for Pharmaceutical Companies
36 Contact Hours - 9 Days
Overview Clinical research is the fastest growing discipline in the expanding medical device and pharmaceutical industries.
Keeping pace with the ever-increasing body of knowledge and new regulatory procedures generated by advances in clinical research is critical to career success. Attendees of this program will gain skills that are beneficial in their professional life. They will learn new proficiencies that may lead to more career options and advanced positions.
They will also gain the skills essential for conducting clinical research, applying statistical theories and analyzing the data and results.
Objectives
Keeping pace with the ever-increasing body of knowledge and new regulatory procedures generated by advances in clinical research is critical to career success. Attendees of this program will gain skills that are beneficial in their professional life. They will learn new proficiencies that may lead to more career options and advanced positions.
They will also gain the skills essential for conducting clinical research, applying statistical theories and analyzing the data and results.
Objectives
At the end of the training, participants will:
- Have an in-depth understanding of key fundamental elements of clinical research including Good clinical Practices.
- Understand important scientific and epidemiologic principles necessary for designing clinical research studies
- Be introduced to the regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials..
- Learn the regulatory requirements for healthcare products, that is, drugs, biologics, diagnostics, and devices. Intended for those interested in regulatory affairs or in the clinical evaluation, development, manufacture, testing and/or commercialization of these products.
- Have an in-depth review of pertinent international regulations and guidelines and relationship to scientific and logistical activities involved in taking a product from research to market.
- Be introduced to the general guidelines of writing each section of a scientific research paper.
- Learn how to write regulatory documents, for example: consent forms , clinical trial protocol, and clinical study report.
- Understand the process of scientific journal publication.
- Be able to read and critically evaluate current research published in the medical literature pertinent to the design, implementation, and evaluation of clinical research.