PG DIPLOMA IN GLOBAL RA

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  • To provide an overview on the general legal requirements to bring a pharmaceutical product to market –whether it is the creation of a new product, or import/export of a product to a new market – and maintaining it afterwards.
  • To provide a sound knowledge and understanding of Global regulatory affairs.
  • To create a thorough understanding of important regulatory concepts.
  • Deliver innovative, breakthrough regulatory strategies for product development and registration.
  • Be proactive and forward thinking; provide timely, comprehensive and robust global regulatory guidance.
  • Understand the pharmaceutical environment and regulatory actions on precedents and utilize such regulatory intelligence.
  • Forge new standards to deliver more predictable outcomes.
  • Increase focus on building and strengthening relationship with regulatory authorities to provide timely expert input into product development, manufacturing and registration.
 

Topic 1:  Introduction to RA profession

  • Regulatory Affairs Profession, role and its importance, overview of worldwide Regulatory agencies.
  •  General Overview of the Pharmaceutical Industry, its functioning, role of various departments like R & D, Production, RA, QA, Project Management, Supply  chain, etc.within the industry

Topic 2:  Overview of Drug Development Process.

  •  New Drug Approval and Development
  •  Preclinical Investigation
  •  Investigational New Drug Application (INDA)
  •  Clinical Investigation
  •  New Drug Application (NDA)
  •  Phase IV (Post marketing Surveillance)
  •  Importance of Pharmacovigilance,
  •  EVMPD and XEVMPD

Topic 3:  Formulation or Product development.

  •  Basic formulation development and manufacturing
  •  Importance of preformulation studies and planning
  •  PDR writing as per ICH Q8

Topic 4:  GMP, GLP and GCP.

  •  Overview of GMP
  •  Overview of GLP
  •  Overview of GCP
  •  ICH GCP Guidance’s and its importance
  •  ICH E3, ICH E6
  •  Importance of PIC/S

Topic 5:  Regulatory System in US (FDA).

  •  History of FDA and Related Regulatory Agencies
  •  FDA & CDER – Organization and responsibilities
  •  Types of Drug applications in US [IND, NDA, ANDA, 505 (b)(2)]
  •  Investigational New Drug Application: INDA
  •  New Drug Application: NDA
  •  Generic Drug Submissions
  •  ANDA submission in detail
  •  Bioequivalence Recommendation for Specific Products
  •  Establishment registration, drug registration and National Drug Code Directory(NDC)
  •  Changes to an approved ANDA and annual reporting
  •  Over-the-Counter Drug Products
  •  Regulation of OTC Drugs
  •  Rx-to-OTC Switch
  •  Patents and Exclusivity
  •  Prescription Drug Labeling, Advertising and Promotion
  •  Labeling Regulations and Requirements
  •  Structured Product Labeling (SPL)

Topic 6:  Medical Device Submissions.

  •  Medical Device Classification (21 CFR 860)
  •  Class I- General Controls
  •  Class II- General Controls and Special Controls
  •  Class III- General Controls and Premarket Approval
  •  Combination Products
  •  510(k) Premarket Notification
  •  Modifications to 510(k) Devices
  •  Traditional 510(k)
  •  Abbreviated 510(k)
  •  Advertising, Promotion and Labeling for Medical Devices and IVDs
  •  In Vitro Diagnostics Submissions and Compliance
  •  FDA Classification and Regulation of IVDs

Topic 7:  Biologics Submissions.

  •  IND Process for Biologics
  •  Preclinical Development Considerations for Biologics
  •  Clinical Development Considerations for Biologics
  •  Manufacturing of Clinical Trial Material for Biologics
  •  BLA Format and Content
  •  BLA Review Process
  •  Biosimilars
  •  Vaccines and Related Biological Products

Topic 8:  Drug Substance Registration.

  •  Drug Master Files (DMF)
  •  Type I —Reserved, no longer applicable
  •  Type II — Drug substance, drug substance intermediate and material used in their preparation, or drug product
  •  Type III — Packaging material
  •  Type IV — Excipients, colorant, flavor, essence or material used in their preparation
  •  Type V — FDA accepted reference material
  •  COS/CEP
  •  ASF

Topic 9:  Life Cycle of Drug Product.

  •  Prior Approval Supplement (PAS)
  •  Post Approval Changes [SUPAC]
  •  Changes Being Effected in 30 Days (CBE-30)
  •  Annual Report
  •  Post marketing Reporting Requirements
  •  Post approval Labeling Changes
  •  Lifecycle Management
  •  FDA Inspection and Enforcement Act
  •  Form FDA 483
  •  Establishment Inspection Report (EIR)
  •  Warning Letters
  •  Recalls, Seizure and Injunctions

Topic 10: Regulatory System in Canada (Health Canada).

  •  New Drug Approval Process
  •  Generic Drug Approval Process

Topic 11: Regulatory System in Europe (EMA).

  •  Pharmaceuticals in the European Union
  •  History of Drug Regulation in European Countries
  •  Centralized Regulatory Authority of European Union (EU)
  •  EUDRALEX: EU Pharmaceutical Legislation
  •  European Medicines Agency (EMA)
  •  Regulation of medicines in the European Union
  •  Marketing Authorization
  •  Centralized Procedure (CP)
  •  Mutual Recognition Procedure (MRP)
  •  Decentralized Procedure (DCP)
  •  National Procedure
  •  Types of Variations

Topic 12: Drug Registration with Rest of the World (ROW).

  •  Introduction and Overview of Row regions and sub-regions
  •  Registration with South-East Asian countries (ASEAN)
  •  Registration with Latin America (Brazil, Mexico),
  •  Registration with Middle East countries (GCC)
  •  Registration in Emerging market (India, Russia, China, Japan, South Africa)

Topic 13: Dossier Preparation-Different Formats used globally.

  •  pCTD [Paper- CTD]
  •  eCTD [Electronic CTD]
  •  ACTD [ASEAN CTD]
  •  NeeS [Non eCTD Electronic Submission]

Topic 14:  Dossier preparation in pCTD and eCTD format.

  •  Introduction and Overview
  •  CTD Format for Each Submission (US/EU)
  •  Module 1 - Administrative and Prescribing Information
  •  Module 2 – Common Technical Document Summaries
  •  Module 3 – Quality Part-CMC
  •  Module 4 - Nonclinical Study Reports
  •  Module 5 - Clinical Study Reports
  •  Electronic Submission
  •  Planning your electronic submission
  •  Regulatory requirements
  •  Tool and Technologies
  •  Electronic Submission Process
  •  NeeS: Non eCTD electronic Submission
  •  eCTD: Electronic submissions with xml backbone files
  •  Electronic Submission Gateway (ESG)

Topic 15:  Dossier preparation in ACTD format.

  •  Introduction and Overview
  •  ACTD Format for ASEAN countries
  •  PART-I - Administrative and Prescribing Information
  •  PART-II – Quality Part-CMC
  •  PAR-III – Nonclinical Study Reports
  •  PART-IV - Clinical Study Reports

Topic 16:  ICH Quality Guidance’s and its importance.

Overview of -.
  •  ICH Q1 - Stability studies
  •  ICH Q2 - Analytical Method Validation
  •  ICH Q3 – Impurities
  •  ICH Q4 - Pharmacopoeias
  •  ICH Q5 - Quality of Biotechnological Products
  •  ICH Q6 – Specifications
  •  ICH Q7 - Good Manufacturing Practice
  •  ICH Q8 - Pharmaceutical Development
  •  ICH Q9 - Quality Risk Management
  •  ICH Q10 - Pharmaceutical Quality system
  •  ICH Q11 - Development and Manufacture of Drug Substances(QbD)

Topic 17: 21CFR Part 11 guidance and its importance.

 

 
  • All those who have completed their Graduation or Post Graduation/Pharma / PhD are eligible to enroll for the course.
  • This course would be beneficial to people who have experience in RA and want to proactively take part in devising RA strategies.
  • Professionals from pharmaceutical companies working in various departments.
 
The admissions to the distance learning courses at Raaj GPRAC open throughout the year.
Fee structure of the courses will be given on request.
  • Elaborate course material, self-assessment assignments and project work details would be provided by the Raaj GPRAC from time to time. Details get updated on the webpage as well.
  • All the students are obliged to timely submit completed assignments (during the pendency of the course) and appear for an online exam at the end of the course.
  • After successful completion, the student will be awarded “Post Graduate Diploma in Global Regulatory Affairs “by Raaj GPRAC.
 
  • We offer professional courses to cater the industry’s need for trained Regulatory Affairs professionals. The information, guidance, practical training and PG Diploma course completion certificate will provide the students with not”one“but”many“opportunities in the industry.
  • This would come true in form of job roles and positions in the field of Regulatory departments in reputed pharmaceutical companies, CRO, BPO, KPO, Food and Food supplement manufacturers, biotechnology companies and consultancy firms.
 
  • We provide job assistance to all our registered candidates. We shall share your resume with all employers in our network and you will also receive all mails regarding jobs available across the globe along with all guidance!!