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Regular Professional Certification Courses

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Advanced course in GLOBAL REGULATORY AFFAIRS [GRA-API, Formulations, Medical Devices, Biosimilars, OTC]

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.

The course will cover role and responsibilities of RA, Drug development, formulation development, GMP/GLP/GCP, DMF/ASMF/CEP, Drug Regulations in USFDA, Europe, ROW countries, Canada, Regulation of OTC drugs, Drug Substance regulation (DMF/ASMF/CEP), Medical Device Regulations, Biosimilar Regulations, Post Approval Changes and Life cycle management of a Drug Product, Structure and organization of CTD(Module1-Module 5), Dossier preparation(eCTD, ACTD, Nees Format), eCTD Submission, CMC Writing and Review Skills ICH Quality Guidance (ICH Q1 ti ICH Q14) and its importance, 21 CFR part 11, Data Integrity, ALCOA, ALCOA+.

REGULATORY AFFAIRS [Formulation]

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.

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+.

REGULATORY AFFAIRS[API]

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.

This course will cover Introduction to RA profession, Characterization and Polymerization of API, Drug Substance Regulation(DMF/ASMF/CEP), Regulation in semi regulated countries, DMF submission in CTD/ ACTD format, 21 CFR part 11 and its importance.

QA-QM [ Quality Assurance and Quality Management]

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.

This course will cover Introduction to QA profession, GMP/GLP, Introduction to ICH guidances and Emphasis on ICH Q 7, Quality Assurance and Regulatory Affairs, Documentation requirements as per GMP compliance, Audit Preparations, Writing SOPs, PICs guidance.

Regulatory Submissions as per CTD-eCTD, ACTD , NeeS

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.

The course will cover Introduction to RA, ICh and CTD, Organization of CTD, Introduction to eCTD, eCTD Granularity, Preparing eCTD Submission, eCTD Specification for USFDA/EU, CMC Writing and Review Skills Electronic Subission Process, 21 CFR part 11.- Data Integrity.

Advanced course in Clinical Research[CR]

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.

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.

Advanced course in Pharmaceutical Documentation [PD]

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.

This course covers importance of good documentation and how to apply, Pharmaceutical Documentation profession, WHO GMP for pharmaceuticals, Documentation of Quality Management System, Documentation and Records, Training & Qualification of Personnel, Good documentation practice for electronic documentation, Validation Documentation, Documentation control, Product development documentation-PDR writing as per ICH Q8, Stability testing and documentation, Quality by Design.

Advanced course in Pharmacovigilance [PV]

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.

This course will cover Introduction and Objectives of Pharmacovigilance, Drug surveillance-WHO, Classification of ADR, The importance of reporting ADR, The effects of ADRs, Pre marketing studies, Post-marketing surveillance (PMS), Pharmacovigilance Methods, Drug Event Monitoring, Uppsala Monitoring Centre, The National Pharmacovigilance Centers, Pharmacovigilance in Drug Regulation, Clinical trial regulation, Post-marketing safety monitoring, Signal Detection & Analysis, Good Pharmacovigilance Practices, Periodic Safety Update Reports: General principles, Submission of PSURs.

Advanced course in Patents Laws and Procedures [IPR]

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.

This course will cover Overview of Pharma Industry and Importance of IPR & Patents, General Overview of the Pharmaceutical Industry, its functioning, role of various Departments, Definitions and interpretation of terms related to Patents System, Enforcement of Patents, Abuse of Patents, International Treaties/Conventions on IPR, Patenting in India - Legislations and Salient Features, Procedures for Patent Applications, US & European Patent Regimes, Business Model Patents - Biotech Patents, Software Patents.

Advanced course in Pharmaceutical Management[PM]

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.

This course will cover Introducing Management Science, National and International Environment for Pharmaceutical Industry, Business Ethics and Corporate Governance, Business Communication, Organizational Behaviour, Human Resource Management, Project Management, Self Management, Pharma Quality Management, Legal and Regulatory aspects of Business, Operations Management, Management Accounting - Basics, Budgeting, Cost cutting, Quality Management & Manufacturing Strategy, Marketing and Sales Management, Importance of Regulatory Intelligence (RI) and different tools.

Advanced course in Medical Writing [MW]

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.

This course will cover Medical Writing Profession, role and its importance, Statistical Principles for Medical Writing, How to become a Competent Medical Writer?, Difference between a Technical and Scientific writing, Different Types of Medical Writing, Medical Writing Style Guide, Writing of Informed consent form (ICF) / Clinical Investigator Brochure(IB) / Clinical Study Report (CSR) and Protocol/ PSUR/DSUR/PBRER / Clinical Trial Registry Summary (CTR) and FDAAA /Preparation of Product LABEL, ICH CTD Modules.

Stability Testing in Pharmaceuticals

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.

This module will cover what is stability, its importance, how to carry out stability testing, Guidance for stability testing as per ICH Q 1.

Effective CMC Writing and Review Skills

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.

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.