Drug Regulatory Affairs

ABOUT CISPACT TRAININGS

‘Cispact Trainings’ is an online education platform providing rigorous industry-relevant training programs designed and delivered in collaboration with world-class faculty and industry. Merging the latest technology, pedagogy, and services, Cispact is creating an immersive learning experience – anytime and anywhere.

We provide high-end professional education for aspiring and experienced professionals in Pharmaceutical and IT domains. Our hybrid platform delivers unique online experience that helps to build cutting-edge expertise, for today and tomorrow.

In Pharmaceutical sector, we provide trainings in Pharmacovigilance (Case Processing and Aggregate Report writing), Medical Writing, Management, Regulatory Affairs, Clinical Research Operations, Computer System Validation, Oracle Argus Configuration and Administrator, Clinical SAS (Base and Advanced) and Intellectual Property Rights.

Course Curriculum

1: Introduction to Global Regulatory Authorities for pharma and healthcare industries

2: Drug Development Process, Clinical Trials and related norms and regulations

3: GMP and other good practices (International perspective of USA, WHO, ICH & Europe / Australia & New Zealand / Gulf Countries (GCC) / Canada / Africa / India etc)

4: Regulatory filings in US, Europe, UK, India, Canada, Australia, South Africa, etc.

5: Quality Assurance and Drug Regulations, ICH and WHO guidelines

6: Dossier preparation in CTD format, eCTD submissions

7: Drug Registration in African Countries.

8: Drug Registration in Gulf (GCC) Countries.

9: Drug Registration in ASEAN Countries.

10: Drug Registration in LATAM Countries.

11: US post approval changes

12: SUPAC guidelines

13: Variation dossiers filling and Renewal dossiers

14: Labelling and artworks preparation

15: RIMS/ registered product life cycle management

16: AYUSH Regulatory Affairs (Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy)

17: Industry specific case studies

FINAL EVALUATION

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