To start with Quality Assurance can be described as sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use. And the Quality control in Clinical Research can be described as the process of conducting trials as per the guidelines mentioned in the Protocol which ensures the Safety, Efficacy of any Investigational Drug.

 

The USFDA is the majorly accepted guideline all across the world followed by regulations of specific countries.

 

The Imperial institute of Clinical Research provides students a comprehensive knowledge and skills in the field of Pharmaceutical & Clinical Research Industry, which will be responsible for conducting the Clinical Research as per the protocol and guidelines. The courses have been reviewed and well accepted by the eminent personalities of Clinical Research who are involved in Clinical Research for more two decades.

 

Eligibility :

MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry, Microbiology, Biotechnology and all professionals working with Pharmaceutical companies, CROs and hospitals.

 

Mode :  

Distance learning / online

 

Validity up to:

6 months from the date of joining*.

 

Academic Assistance:  

5 hours E-learning with in-house faculty.

 

Exam Pattern:

E- VIVA and project submission within course validity period.

 

Placement Assistance:

2 hours E-session with Placement Department + 3 chances to appear for an interview with in course validity period.

 

Study Material:

Study Material will be provided at correspondence address.

 

Program Details :

  • Introduction to Clinical Research, Principles of Pharmacology (including toxicology) & Drug Discovery & Development

  • Clinical Trail Documents, Roles & Responsibilities of Key Stakeholders

  • Introduction to Regulatory Affairs:

I.    Regulatory authority  governing clinical trials of New Drugs & Generic Drugs (FDA, EMEA & MHLW), ICH Overview, CIOMS, WHO

II.    Indian Regulatory Environment –

  i.    Introduction to major regulatory bodies in India – CDSCO, DCGI, DTB,

  ii.    Introduction to D & C Act, Schedule Y, Indian GCP, ICMR,

       III.    Regulation applicable for Pharmaceutical Devices

  • Introduction to Quality Management system Audits: Types of Audit, Audit components (Audit checklist) & Audit Process, Audit findings, Preparing for an Audit (Auditors & Auditee’s perspective),  Phases of an Audit, Regulatory requirements for an Audit

      I.         Need for Quality in changing Clinical trial Landscape

    II.        Components of Quality Management System: QMP, QA, QC

  III.        Tools for QC: SOPs, Operation Manual, Checklists,

   IV.        Quality control vs. Quality Assurance

     V.        Tools for QA: Audits & Inspections

  •  Audits: Types of Audit, Audit components (Audit checklist) & Audit Process, Audit findings, Preparing for an Audit (Auditors & Auditee’s perspective),  Phases of an Audit, Regulatory requirements for an Audit

  •  Process Mapping in Clinical trials – PV, Operations, CDM, BA/BE

  • Regulatory Inspections

       I.      Introduction to Regulatory Inspections

     II.      FDA Inspections

   III.     EMEA & MHRA Inspections- Conduct, Reporting & Consequences of Inspections

    IV.     ANVISA Inspections

      V.     DCGI Inspections: Types of Inspection, Observations & Reporting of Inspection

    VI.     IEC/IRB Inspections

Comparative analysis of FDA and EMEA Inspections

(* The Date of Joining is the date on which 1st study material will be dispatched to you from institute )

 

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(* for more details please contact on Mob : : 08511188845 or write on ahmedabad@iicrindia.com)

 

* “Fees (Registration & program fees)  once paid will not be refundable”

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