India has been an important region for the conduct of clinical trials by global companies. The Drugs and Cosmetics Rules of 1945 have undergone numerous amendments to ensure the adequate regulation of drugs, and recent amendments have focused on good clinical practice and protection of patients in clinical trials. During this webinar, the new rules related to compensation for clinical trial-related injuries and deaths, safety reporting, registration of Ethics Committees, and registration of clinical trials will be discussed. The impact that the implementation of these rules may have on the conduct of clinical trials will be examined as well.
- Clinical trial-related injury or death - Compensation and Safety reporting requirements
- Registration of Ethics Committees
- Clinical Trial permission and registration
Who Should Attend
- Regulatory associates
- Regulatory managers
- Clinical Research associates
- Clinical Research coordinators
- Study site investigators
- Project managers
- Drugs Safety managers
- Ethics committee/Institutional Review board members
- Insurance companies
At the conclusion of this webinar, participants should be able to:
- Discuss the change in India’s regulatory landscape
- Identify critical areas where operational changes will be required
- Describe the additional responsibilities that stakeholders will need to address regarding the new rules
- Describe the challenges and uncertainties with implementation of the new rules
for minimum system requirements.
- Government (Full Time) Individual
- Charitable Nonprofit/Academia Individual
- Group Site
- Group Plus
- Member Individual
- NonMember Individual
- Group site registration is a license for ONE internet login allowing multiple viewers from one location.
- Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.
No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.