Technology TechnologyData Science Data ScienceManagement ManagementDegree Programs Degree ProgramsMoreMore
    Courses
Blog Blog
    Trending Articles
    Course Recommendations
Search Icon
LoginSign Up
Jamia Hamdard University - Extension Center
Jamia Hamdard University - Extension Center Logo

Advanced Diploma in Drug Regulatory Affairs (ADDRA) 
offered by Jamia Hamdard University - Extension Center

    Advanced Diploma in Drug Regulatory Affairs (ADDRA)
     at 
    Jamia Hamdard University - Extension Center 
    Overview

    Equip you with a specialized skillset for navigating the complex world of drug regulations

    Duration

    12 months

    Start from

    		Start Now

    Total fee

    ₹24,500

    Mode of learning

    		Online

    Official Website

    		Go to Website External Link Icon

    Credential

    Certificate

    Advanced Diploma in Drug Regulatory Affairs (ADDRA)
     at 
    Jamia Hamdard University - Extension Center 
    Highlights

    • Earn a diploma from Jamia Hamdard University
    • Fee payment can be done in instalments
    • Learn from industry experts
    Details Icon

    Advanced Diploma in Drug Regulatory Affairs (ADDRA)
     at 
    Jamia Hamdard University - Extension Center 
    Course details

    Skills you will learn
    MarketingExport ImportQuality Management
    Who should do this course?
    • For individuals who want to enhance their knowledge & skills in the field
    What are the course deliverables?
    • Gain a comprehensive understanding of the regulatory frameworks governing drug development, registration, and marketing approval in different regions, including key regulatory bodies like the US FDA, EMA (Europe), and ICH (International Council for Harmonisation)
    • Develop in-depth knowledge of relevant national and international drug regulations, including Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP)
    • Master the intricacies of the drug registration process, including dossier preparation, data compilation, and communication with regulatory agencies
    • Develop strong skills in writing and compiling regulatory documents such as Common Technical Documents (CTD) and electronic Common Technical Documents (eCTD) for marketing authorization applications
    • Learn how to develop effective regulatory strategies to ensure smooth drug development, registration, and market access
    Read more
    More about this course
    • The main objective of this Programme is to provide an interdisciplinary knowledge of pharmacy and law as applicable in the field of pharmaceutical regulation at national and international levels
    • The course prepares the students to pursue career in pharmaceutical industry, drug licensing and control authorities, and export- import agencies dealing with the pharmaceuticals

    Advanced Diploma in Drug Regulatory Affairs (ADDRA)
     at 
    Jamia Hamdard University - Extension Center 
    Curriculum

    An Introduction to Pharmaceutical Drug Regulatory Affairs

    General Pharmaceutical Laws and Guidelines

    Drug Regulatory Affairs in India

    Information and Quality Management

    Chemical, Pharmaceutical and Biological aspects of Regulatory Documentation

    Clinical Trials and Health Care Policies

    International Licensing

    Regulatory Considerations in Controlled Drug Delivery and Future Aspects of Biopharmaceuticals

    Advanced Diploma in Drug Regulatory Affairs (ADDRA)
     at 
    Jamia Hamdard University - Extension Center 
    Entry Requirements

    Eligibility criteriaUp Arrow Icon

    Advanced Diploma in Drug Regulatory Affairs (ADDRA)
     at 
    Jamia Hamdard University - Extension Center 
    Admission Process

      Important Dates

      Sep 18, 2024
      Course Commencement Date

      Other courses offered by Jamia Hamdard University - Extension Center

      name

      Bachelor of Business Administration

      Jamia Hamdard University - Extension CenterDegree
      – / –
      3 years
      – / –
      name

      Bachelor of Computer Application (BCA)

      Jamia Hamdard University - Extension CenterDegreeStar Icon3.8
      – / –
      3 years
      – / –
      name

      Post Graduate Diploma in Pharmaceutical Regulatory Affair

      Jamia Hamdard University - Extension CenterCertificate
      ₹24.5 K
      12 months
      – / –
      Quality ManagementCompliance
      View Other 7 CoursesRight Arrow Icon
      qna

      Advanced Diploma in Drug Regulatory Affairs (ADDRA)
       at 
      Jamia Hamdard University - Extension Center 

      Student Forum

      chatAnything you would want to ask experts?
      Write here...
      Home Icon/Colleges in Delhi/Jamia Hamdard University - Extension Center/Courses/Advanced Diploma in Drug Regulatory Affairs (ADDRA)

      Advanced Diploma in Drug Regulatory Affairs (ADDRA)
       at 
      Jamia Hamdard University - Extension Center 
      Contact Information

      Address

      11, First Floor ,opp Metro Pillar No 118
      Landmark: Opp. Shanti Mukund Hospital
      Delhi

      Phone
      01145210022
      Email
      info@neevedu.com
      Go to College Website ->