Workshops on Clinical Research and Medical Regulations | 27-29 Sept 2016 ~ helpBIOTECH

14 September 2016

Workshops on Clinical Research and Medical Regulations | 27-29 Sept 2016

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CDSA, IISER Pune, CSIR-NCL-Venture Centrer and Prashanti Cancer Care Mission, Pune presents

27, 28, 29 September 2016

Workshops on Clinical Research and Medical Regulations

The following programs are being jointly organised by CDSA, IISER Pune, CSIR-NCL-Venture Center and Prashanti Cancer Care Mission, Pune.

Tuesday, 27 Sept. 2016

Good Clinical Practice

Wednesday, 28 Sept. 2016

Current Regulatory Requirement for the Members of Institutional Ethics Committee

Thursday, 29 Sept. 2016

Medical Devices and in vitro Diagnostics (IVD) Kits

One Day Awareness Program on Good Clinical Practice
Tuesday, 27 Sept. 2016 | 8.30 am - 5.45 pm | IISER

About the Program

All of the above Institutions have joined hands together to hold a One Day Awareness Program on “Good Clinical Practice”. This program will give participants an overview about various aspects being covered starting from the differences in the guidelines from CDSCO, ICH to WHO, various regulatory requirements, ethical considerations, roles and responsibilities of various stakeholders like Sponsor, Institution, Investigator, Monitor etc. It will make participants aware of various clinical trial documentation requirements like protocol, investigator’s brochure, informed consent form, case record form, clinical study report etc. This will make the participants understand and learn record keeping and data handling requirements and quality assurance in the conduct of a clinical trial or research, when done in compliance with GCP requirements.

Learning Objective:

To understand the basics of Good Clinical Practice, so that the participants can imbibe them and ensure compliance, give public an assurance that the rights, safety and well-being of human subjects involved in research are well protected.

Expected Outcome:
At the end of the program, the participants should be:

  • Aware about the basic concepts of GCP.
  • Understand Indian Regulations that govern human research.
  • Know how to ensure protection of rights, safety and welfare of human participants.
  • Be cognizant of quality, reliability and integrity of data. Know the ‘Do’s and ‘Don’ts and be able to identify ‘right’ from ‘wrong’ approaches.
  • Get acquainted with various standards and guidelines for the conduct of clinical research.
  • Understand the simple formula, Good Clinical practice = Ethics + Quality Data.

Target Participants:

Investigators, Ethics Committee Members, Clinical trial or research team members. Any one working in the area of clinical trial or research or aspires to work in this area.

Registration Fees:

Registration form (Online)

To know more about the workshop click here

Current Regulatory Requirement for the Members of Institutional Ethics Committee
Wednesday, 28 Sept. 2016 | 8.30 am - 5. 30 pm | IISER
Learning Objective:

To strengthen and empower the Institutional Ethics Committee (IEC) members to ensure that they understand scientific, regulatory norms, ethical design, conduct and reporting of clinical research that will be of uniform nature and meets national and international quality standards.

Expected Outcome:
At the end of the program, the participants will be awareness about current guidelines and regulations for the conduct of clinical research in India so as to ensure that the right, safety and well-being of human participants involved in research are well protected.
Target Participants:

Members from Ethics Committees will be given priority. Investigators and clinical trial/research team members are encouraged to apply.
Registration fees:

Registration form (Online)

To know more about the workshop click here

Current Regulation on Medical Devices and in vitro Diagnostics (IVD) Kits
Thursday, 29 Sept. 2016 | 8.30 am - 5.30 pm | Venture Center
Learning Objective:

To provide direct, relevant and valuable information on key aspects of Medical Devices & in vitro Diagnostic Kits including its regulations in India.

Expected Outcome:

At the end of the program, the participants will be aware about the regulations that govern medical devices and in vitro diagnostic kits in India. Cognizance about design and development of medical devices, various standards, CECertifications & ISO 13485. Understanding biocompatibility and clinical trial of medical device. Regulations for import, manufacture and sale of medical devices. It will provide an opportunity to the participants to meet the regulators and clarify doubts.

Target Participants:
SMEs, Academic Research Organisation, Investigators involved in Medical Devices & Diagnostics.
Registration fees:

Registration form (Online)

To know more about the workshop click here

Please note the following:

1 - Kindly keep your cheque/ DD/ online transaction details ready with you before you start filling up the form.
2- Without the payment details the registration form cannot be submitted.
3- Registration will not be confirmed until actual receipt of DD/Cheque/online transfer of registration fees.
4- Registration will be confirmed only on cross checking of the uploaded ID documents.
5- Accommodation is available on payment for first 100 participants on first come first serve basis.

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