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Effective CMC Writing and Review Skills

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Eligibility:

    B.Pharm/ M.Pharm/ PhD/ B.Tech/ M.Tech/ BSc/ MSc/ BAMS/ BHMS/ MDS/ MBBS/ MD/ etc.. All those who would like to make a career in Regulatory Affaires, QA, Clinincal Research, and Medical Affairs.

  • Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

This course will cover Basics of CMCs, effective technical CMC Writing skills, CTD Module 3-Quality Overall Summary, Purpose and Content of Module 3, Difference between technical and scientific writing skills, How to organize CTD modules, Regulatory challenges of CMC requirements

REGULATORY AFFAIRS [Formulation]

Eligibility:

    B.Pharm/ M.Pharm/ PhD/ B.Tech/ M.Tech/ BSc/ MSc/ BAMS/ BHMS/ MDS/ MBBS/ MD/ etc.. All those who would like to make a career in Regulatory Affaires, QA, Clinincal Research, and Medical Affairs.

  • Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

The course covers role and responsibility of RA, Importance of GMP/GLP/GCP, Drug Development process, Formulation Development, DMF/ASMF, Drug Regulation in US, Europe, ROW countries, Organization and structure of CTD-(Module 1 - Module 5), Dossier preparation as per CTD-eCTD format, CMC Writing and Review Skills , ICH Quality Guidance and its Importance (ICH Q1-ICH Q14), 21 CFR part 11.-Data Integrity-ALCOA, ALCOA+

Advanced course in Clinical Research[CR]

Eligibility:

    B.Pharm/ M.Pharm/ PhD/ B.Tech/ M.Tech/ BSc/ MSc/ BAMS/ BHMS/ MDS/ MBBS/ MD/ etc.. All those who would like to make a career in Regulatory Affaires, QA, Clinincal Research, and Medical Affairs.

  • Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

This course will cover Introduction to Clinical Profession, Overview of Drug Development Process including clinical trials, Regulatory process in preclinical drug development, Ethical Principles and their origin, Ethics in clinical research: As per ICMR & GCP, ICH E6. Fundamentals of Monitoring Clinical Trials, Principles of Project Management, Clinical Safety & Pharmacovigilance

Good Manufacturing Practice

Eligibility:

  • B.Pharm/ M.Pharm/ PhD/ B.Tech/ M.tech/ BSc/ MSc/ BAMS/ BHMS/ MDS/ MBBS/ MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

  • Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc

Course Description

This course will cover GMP Guidance and its importance in Pharma industry, ICH Q 6 guidance, How to implement GMP.