This training program will elucidate IRB composition, responsibilities and function and detail the types of review processes and regulatory guidelines. It will also discuss post-approval monitoring, administrative actions and approvals/denials.
Why Should You Attend:
This training will introduce attendees to the essentials of the purpose of the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) and their regulatory function in impacting clinical trials. The biotech industry has exhibited a remarkable growth in the last decade due to the advances in technology and the demand for new therapeutics. Consequently, several pipeline drug compounds have been synthesized and tested for various safety and efficacy concerns. After establishing the biological function and chemical potency of pipeline drugs, FDA requires that they be tested on a small population of humans in phases.
However, better awareness on the ethical concerns of such tests has provided new regulatory restraints on how the pipeline drugs can be tested clinically. Globalization has furthermore made the adherence to appropriate international laws a vital step in the drug development.
In this training, an overall understanding of IRB and the types of regulatory rules that the scientific community needs to comply will be presented. This training program will guide attendees in designing their research plan and model their business goals in a compliant manner. The instructor through his vast experience in research combined with his expertise in regulatory processes will elucidate why compliance is not just a hurdle but it is essential to foster an institutional culture of responsibility.
Note: Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.
