Lecture series on Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is an international ethical and quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the rights, safety, and well-being of human research participants are well protected, data and reported results are credible and accurate. Creating awareness of GCP is mandatory when it comes to innovation in medicine and healthcare. The recent launch of the New Drugs and Clinical Trials Rules, 2019 (NDCT), on March 19, 2019, opens up a new set of opportunities to accelerate innovations in India. Alongside are the challenges to ensure that the rules are widely disseminated, properly explained and correctly interpreted. Poor understanding of the current regulatory requirements (mainly the do’s and don’ts) mixed with inadequate compliance to best global practices may lead to delays and failures (financial & non-financial loss) which can be significantly reduced through awareness and empowerment through such programmes.

Day 1

• Overview of Good Clinical Practice
• New Drugs and Clinical Trials Rules (2019): Salient features
• National ethical guidelines for biomedical and health research involving human participants (2017)
• National ethical guidelines for biomedical research involving children (2017)
• Ethics committee: registration and re-registration
• Accreditation standards for ethics committees
• Open forum for question and answers

Exercises:

• Role play
• Case studies
• Quiz (semi-final)

Day 2

• Roles and responsibilities of all stakeholders: Sponsor, Monitor, Institution, Investigator
• Clinical trial documentation
• Record keeping and data handling
• Open forum for question and answers

Exercises:

• Group work and presentations
• Individual exercises
• Quiz (Final).

During this workshop, participants shall learn about:

1. The principles of GCP, roles and responsibilities of various stakeholders involved in a clinical research/trial.
2. Current ethical and regulatory requirements for conducting clinical research/trial in India.
3. Salient features of the New Drugs and Clinical Trials Rules, 2019
4. National ethical guidelines for biomedical and health research involving human participants, 2017 and the national ethical guidelines for biomedical research involving children, 2017.
5. Various requirements for seeking registration, re-registration of ethics committees and accreditation standards.

At the end of this programme, the participants shall be able to:

1. Understand the GCP principles.
2. Seek cognizance of the regulations and guidelines that govern human research in India.
3. Know the best practices in clinical trials/research.
4. Understand and distinguish ‘rights’ from ‘wrong’ approaches.
5. Get an opportunity to clarify doubts about the implementation of GCP.

• Interested personnel from the industry, research institutions, hospitals, clinical trial centers, academic institutions, Government Bodies, etc. with minimum academic qualification of (BSc/MSc/PhD/BPharm/MPharm/ BAMS/BHMS/BDS/MDS/MBBS/MD/DM) and at least 2 years of work experience are eligible to apply for the programme.
• There is no age limit to apply for the programme.
• Interested personnel working in the area of drug development and clinical trials/research may be well-suited to apply for the programme.
• Ethics (human) committee members, clinical investigators, faculty members/senior residents/PG from medical/ dental institutions, nurses, faculty/research scholars (Biomedical sciences, pharmaceutical sciences), hospital/health care administrators, clinical trial/research team members like clinical research associate, clinical research coordinators, clinical data managers, monitors, auditors, etc. are encouraged to apply for the programme.
• Limited seats shall be available for non-working professionals who have completed their post-graduate/doctorate degrees in areas of science and technology and seeking employment.
• Only those applicants with relevant background and expertise in the area of training are encouraged to apply for the programme.

In order to apply for the programme, please click on the ‘Apply Now’ button. Application form comprises of questions related to participant profile, academic qualifications, work experience, achievements, etc. As part of the application, following is required to be submitted along with the application –

1. Date of birth proof ID (Driver’s License, Aadhar, PAN Card, Passport)
2. Endorsement Letter from head of department/organization (For working professionals)
3. Certificate of highest academic qualification
4. Screenshot of online payment

In case of inability to upload document along with the application form, please check the size of the document. The permissible limit of each document is 1 MB.

A nominal amount of refundable commitment fee of Rs. 1,500/- shall be charged from applicants to ensure only serious candidates applies for this programme. The fees need to be paid as part of the application form using a safe and secure integrated payment gateway. Please mention your bank account details in the application form in order to refund the fees. The amount shall be refund to the non-selected applicants and selected applicants after the training programme. Fees shall not be refunded to the candidate who have confirmed their participation and not attending the programme for the entire duration of the workshop. Processing fees of about 2.6% shall be deducted while refunding the commitment fees to the applicants.

Suitable candidates shall be selected based on eligibility criteria and merit of their application by Selection Committee. Applications found to be incomplete, ineligible and redundant shall not be shortlisted for training. Candidates shall be informed of their selection or non-selection by email. Selected participants shall confirm their participant to BCIL immediately on receipt of email by BCIL. In case the selected candidate shall be unavailable to attend the programme after confirmation, he/she shall inform BCIL immediately. Selected candidates cannot nominate another colleague/friend from their organization.

For the out-station participants, accommodation on twin sharing basis and hospitality arrangements shall be made available for the duration of the programme by CDSA, Faridabad. Conveyance shall be provided from the accommodation facility to the programme venue by CDSA, Faridabad. Accommodation arrangements shall be made available only for those participants who place a request for it in the application form. Please note that the participant shall make his/her own travel arrangements to reach the venue of the workshop/accommodation from railway station/airport. No travel allowance shall be given to the participants.

Participants shall have to attend the full 2 - day programme. Attendance shall be compulsory for each day of the programme. Certificate of participation shall be awarded to the participants on successful completing the entire duration of the training programme.

You may kindly contact nbmworkshop@biotech.co.in or 011-23219064-67 for any further queries regarding the programme.