Post Graduate Diploma in Drug Regulatory Affairs Syllabus - Saheed Mahilal Institute (SMI, Palwal)

  • Years 1 Years
  • Type Course Post Graduate
  • stream Medical
  • Delivery Mode
Written By universitykart team | Last updated date Jul, 07, 2024

The Post Graduate Diploma in Drug Regulatory Affairs syllabus at Saheed Mahilal Institute (SMI), Palwal is designed to provide overall knowledge to the students with a strong foundation. Post Graduate Diploma in Drug Regulatory Affairs faculty at Saheed Mahilal Institute (SMI) specially focus on in-depth learning to relevant subjects. At first semester syllabus of Post Graduate Diploma in Drug Regulatory Affairs at Saheed Mahilal Institute (SMI), students learn the basics of programme. A strong foundation is very important for comprehensive learning. Post Graduate Diploma in Drug Regulatory Affairs syllabus at Saheed Mahilal Institute (SMI), Palwal maintains a balance between theoretical knowledge and practical knowledge.

Post Graduate Diploma in Drug Regulatory Affairs first year students at Saheed Mahilal Institute (SMI) are introduced with core subjects. Then they are encouraged to explore other area for a broader perspective. Saheed Mahilal Institute (SMI), Palwal also provides practical training sessions, workshops, projects, and case studies to enhance student skills. Post Graduate Diploma in Drug Regulatory Affairs syllabus at Saheed Mahilal Institute (SMI), Palwal is also frequently updated to give industry relevant training and knowledge to students. Saheed Mahilal Institute (SMI) strives to provide a nurturing environment where students can learn new skills. The hands-on training sessions at Saheed Mahilal Institute (SMI) enable Post Graduate Diploma in Drug Regulatory Affairs students to apply knowledge and skills in a controlled environment and get required experience.

According to syllabus of Post Graduate Diploma in Drug Regulatory Affairs progress, students learn advanced topics and complex concepts. The Post Graduate Diploma in Drug Regulatory Affairs curriculum at Saheed Mahilal Institute (SMI), Palwal mainly focuses on analytical and critical thinking. As the Post Graduate Diploma in Drug Regulatory Affairs course unfolds, students develop several important skills that increases their employability. As per syllabus of Post Graduate Diploma in Drug Regulatory Affairs at Saheed Mahilal Institute (SMI) also includes real-life projects and internship programs. It helps students critical thinking and gives them real-world experience.

Post Graduate Diploma in Drug Regulatory Affairs curriculum at Saheed Mahilal Institute (SMI) includes group discussions, guest lectures, case studies, and skill development workshops to enhance the learning experience. The Post Graduate Diploma in Drug Regulatory Affairs syllabus at Saheed Mahilal Institute (SMI) aims to create well-rounded professionals equipped with the necessary skills and knowledge to succeed in their chosen fields.

Additional curriculum at Saheed Mahilal Institute (SMI)

  1. Workshops and Seminars - Regular sessions with industry experts help Post Graduate Diploma in Drug Regulatory Affairs students at Saheed Mahilal Institute (SMI) to stay updated with current trends.
  2. Group Projects - Collaborative projects according to Saheed Mahilal Institute (SMI) syllabus develop teamwork and problem-solving skills.
  3. Case Studies - Post Graduate Diploma in Drug Regulatory Affairs syllabus offers analysis of real-world scenarios to apply theoretical knowledge.
  4. Extracurricular Activities - Saheed Mahilal Institute (SMI) offers several activities like sports, clubs, societies, etc. to encourage overall development.

Note: Given below syllabus is based on the available web sources. Please verify with the Saheed Mahilal Institute (SMI), Palwal for latest Post Graduate Diploma in Drug Regulatory Affairs curriculum.

Syllabus & Subjects of Post Graduate Diploma in Drug Regulatory Affairs  

A Post Graduate Diploma in Drug Regulatory Affairs is a specialized program designed to equip students with in-depth knowledge and practical skills in navigating the complex regulatory landscape of the pharmaceutical industry. In the first semester, students delve into foundational concepts, starting with an introduction to Drug Regulatory Affairs. This module provides an overview of regulatory agencies and their pivotal roles, alongside a historical context of drug regulation. Additionally, international harmonization efforts are explored, highlighting the global nature of drug approval processes.The second module of the first semester focuses on Pharmaceutical Legislation and Compliance. Here, students delve into the intricacies of both national and international pharmaceutical laws, gaining a comprehensive understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). These critical components of pharmaceutical quality assurance are essential for ensuring the safety and efficacy of drugs. Moving into the second semester, the curriculum delves deeper into critical areas of drug development. The Drug Development Process module covers the various phases, from pre-clinical to clinical development, culminating in key milestones like the Investigational New Drug (IND) application and the New Drug Application (NDA). Understanding these processes is fundamental for professionals working in regulatory affairs, as they play a pivotal role in shepherding drugs from concept to market.

Syllabus of Post Graduate Diploma in Drug Regulatory Affairs

S.NoSubjects
1Introduction to Global Regulatory Authorities for pharma and healthcare industries
2Drug Development Process, Clinical Trials, and related norms and regulations
3Quality Assurance and Drug Regulations, ICH, and WHO guidelines
4Dossier preparation in CTD format, eCTD submissions
5Healthcare Industry IPR, Patents, copyrights, and Trademarks
6Pharma and Healthcare products- Marketing, Import, and Export regulations
7Indian GMP Regulations
8Drug Registration in African Countries
9Drug Registration in Gulf (GCC) Countries
10AYUSH Regulatory Affairs (Ayurveda, Unani, Siddha, Homeopathy, Yoga, and Naturopathy)
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