InstructorRoyed Training
TypeOnline Course
Price$790 USD / 39500 INR.
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drug regulatory affairs pharmacovigilance

Introduction

Course Type

Course Duration

Eligibility

Certification

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About RA

regulatory affairs pharmacovigilance course

Drug regulatory affairs and pharmacovigilance course provides understanding of both the domain regulation and safety in a single course. Hence, one can learn drug regulation, registration, marketing authorization submission management along with the drug safety and monitoring aspects. This dual specialization course helps user to get certified with the two separate certification, i.e. drug regulatory affairs and pharmacovigilance.

This PG Certification is designed to create effective Regulatory Affairs and pharmacovigilance Manager for Pharmaceutical Industry. Most importantly, this course provides practical knowledge and real life job simulation of both the specialization under single course. Hence, this course is ideal for the professionals who want to have knowledge and certification of both drug regulatory affairs and pharmacovigilance. In fact, the two different certificate will enrich the professional competency.

Online Self Paced Learning

In this online self-paced modules, participant will be understanding about the drug regulation, registration and safety management in detail. Then, stages of drug discovery and development, investigational new drug application, new drug application, handling of different phases of clinical trial, generic drug approval process, Abbreviated new drug applications will be covered in phased manner for easy understanding. Further more, the course will provides extensive training on dossier, drug master file, site master file preparation and filing. Above all, course covers the plant management and advanced plant certification management process in detail. Moreover, apart from the regulatory aspects course covers intensive training on pharmacovigilance aspects like drug safety, monitoring and pharmacovigilance strategic planning.

Who should attend this course? 

  • Those who are in drug regulatory affairs, pharmacovigilance and related department.
  • Professionals from drug discovery development.
  • Professionals of pharmacovigilance background who want to have in-depth knowledge about the pharmacovigilance.
  • Fresher or beginners, Those who want to make a career in drug regulatory department or in pharmacovigilance.

Course Code: RYD-101

Course Title: PG Certification in Drug Regulatory Affairs (PGDRA)

Online distance learning course. So, course can be accessed online across anywhere 24×7.

1 Year

Any body who wants to acquire drug regulatory affairs competency should attend the course.

Certificate will be provided at the end of the successful completion of the course. Two separate certificates will be issued. One on drug regulatory affairs and other on pharmacovigilance. 

  • Orientation to job related practical aspects of the drug regulatory managers, is covered in this course extensively.
  • Simulation to real life working in regulatory affairs and pharmacovigilance department. It help to enhance the regulatory strategic decision making.
  • Advance training on drug registration requirements for various regulatory bodies in terms of the drug registration and drug safety management.
  • Access to Case Studies to learn about the drug registration steps.

Career in Drug Regulatory Affairs

A career in Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

The Pharma and biopharma industry is growing at a rapid pace, but there is a rising concern over the safety and efficacy. Hence, the major objective of the regulatory department to maintain safety and efficacy of the drugs and biopharmaceutical molecules. In fact, to maintain safety and efficacy in pharmaceutical and biopharmaceutical products, regulatory agencies like US FDA, EMA, MHRA UK, DCGI, TGA – Australia, NMPA – China etc. all over the world are imposing number of regulation. Therefore, these regulations are evolving and changing every other day. Most importantly, regulatory professionals must have thorough knowledge about the updated regulations. Certainly, sound regulatory knowledge helps them to take strategic decision effectively. Hence, this has resulted in creation of regulatory department with certified regulatory affairs professionals. Therefore, it help companies to meet these requirements with ease.

About regulatory affairs job>> Learn here

Career in Pharmacovigilance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Pharmacovigilance deals with 4 important aspects. Adverse Event Case Management including expedited reporting, Aggregate Reporting, Signal Intelligence; and Risk Management. A professionals should have excellent understanding on these aspects. The aims of pharmacovigilance within the industry are essentially the same as those of regulatory agencies; that is to protect patients from unnecessary harm by identifying previously unrecognised drug hazards, elucidating pre-disposing factors, refuting false safety signals and quantifying risk in relation to benefit. Although the perspectives of companies and the regulatory agencies may be different they now work more and more closely together and share information. However, central pharmacovigilance units in major pharmaceutical companies in many instances are far better resourced and have much greater ‘in-house’ expertise on the safety of their particular products.

Section 1Fundamental of Drug Discovery and Development | US Regulatory Affairs
Lecture 1Introduction to R&D Process & drug discovery
Lecture 2Investigational New Drug Application
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies 
Lecture 7Types and Timing of Non-clinical Studies 
Lecture 8USFDA Expedited Programs (Detailed Understanding)
Lecture 9505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 10Concept of Authorized Generics: Key Understanding
Lecture 11Concept of Exploratory IND
Lecture 12Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 13Orphan Drug Designation
Lecture 14Advance Learning on 505B2 Pathway
Lecture 15Chemistry, Manufacturing & Controls - Fundamental Understanding
Lecture 16Review on Drug Discovery and Development 
Lecture 17Complete Response Letter | Key understanding | Management and Action Plan
Lecture 18Handling of orange book
Lecture 19Review on Drug Discovery and Development 
Lecture 20Understanding on Clinical Trials  and Clinical Research 
Lecture 21Clinical Trial Protocol Writing
Lecture 22Ethics in Clinical Research
Lecture 23Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 24FDA Forms and How to fill the resources
Lecture 25Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 26Preformulation Study in Drug Development 
Lecture 27Regulatory Requirements for Preformulation Study 
Lecture 28Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies  
Lecture 29Introduction to ICH | Members | Guidelines 
Lecture 30ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 31ICH Q2 : Analytical Validation 
Lecture 32ICH Q3 : Impurities
Lecture 33Rest of ICH Q Family Guidelines
Lecture 34Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets 
Lecture 35Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Section 2European Drug Regulatory Affairs
Lecture 36Orientation to European Countries and National Regulatory Bodies
Lecture 37EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 38Overview of EU Regulation 
Lecture 39EMA and EMA Authorisation Process
Lecture 40EU MA Application Types and Strategic Planning
Lecture 41EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 42EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 43Validity of the EU MA  - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 44Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 45EU Orphan Medicinal Products Regulation
Lecture 46EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 47Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 48Summary of Product Characteristics 
Lecture 49Compassionate Use
Lecture 50IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 51Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 52Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 53EU Prime Designation 
Lecture 54Accelerated assessment by EMEA
Lecture 55EU Adaptive Pathway
Lecture 56European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 57SPOR  - Concept of Master Data Management  
Lecture 58MHRA - UK Regulation 
Lecture 59The 'sunset clause' for marketing authorisation of pharmaceuticals
Section 3 Regulatory Strategic Management and planning
Lecture 60Regulatory Strategies in different phases of Clinical Trial
Lecture 61Advance study on Para IV Filing
Lecture 62Para IV Notice
Lecture 63Evergreening - Patent Life Extension Strategies
Lecture 64Pay For Delay Strategy
Lecture 65REMS Strategic Planning
Lecture 66Compulsory Licensing
Lecture 67Licensing & Technology Transfer
Lecture 68In-Licensing Vs. Outlicensing
Lecture 69LOE Strategies for Innovator Brands with case study
Lecture 70Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 71Drug Re-purposing
Lecture 72Practical Queries on different USFDA application and Filing
Lecture 73Publication Management from Regulatory perspective
Lecture 74Juxtapid Case Study
Lecture 75New Indication Approval Process and Promotion
Lecture 76OTC Switch
Section 4Good Manufacturing Practices
Lecture 77Certification Pharmaceutical Companies / Plants
Lecture 78Premises & Plant Layout Designing
Lecture 79Sanitation and Hygiene
Lecture 80Equipment
Lecture 81Production Modules
Lecture 82GMP Documentation
Lecture 83Quality Control
Lecture 84Handling of Product Complaint
Lecture 85GMP Storage
Lecture 86ISO and ISO Audits
Lecture 87Pharmaceutical SOPs
Lecture 88SOP Automation
Section 5 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 89Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 90CMC Dossier & Compliance Management
Lecture 91Electronic Common Technical Document (ECTD)
Lecture 92Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 93Key Consideration for Drug Master File Preparation and Submission 
Lecture 94Practical Understanding on Drug Master File Preparation and Submission
Lecture 95Site Master File - Detailed Understanding 
Lecture 96DMF Completeness Assessment
Lecture 97Drug Master File - Fees
Lecture 98Drug Master File - Global Perspective [Across Different Regions]
Lecture 99Importance of effective dossier management
Lecture 100Common deficiencies in CTD submission dossier
Lecture 101Certificate of Analysis
Lecture 102Detailed Understanding on ANDA Fees
Lecture 103Prior Approval Submission 
Lecture 104Detailed Understanding on ANDA Fees
Lecture 105Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 106NCE Vs. 505b2 application - Case Based Learning 
Lecture 107FTF - 180 Days Exclusivity - Case Based Learning
Lecture 108Classic case study of the 505b2 filing : Case Based Learning
Lecture 109Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 110Discussion on 85 common deficiency in CTD submission dossier
Lecture 111Asean Common Technical Document (ACTD) 
Section 6Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 112Data Integrity issues in Pharmaceutical Industry
Lecture 113Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 114Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 115RTQs | Response to Queries | How to handle Regulatory Queries  
Section 7Bioequivalence Study
Lecture 116PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 117Bioequivalence Study | Study design | Different types of BE Studies
Lecture 118Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 119Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 120Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 121Bioequivalence Study - Discussion - Dissolution Testing
Lecture 122Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 8Variation Management
Lecture 123Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 124Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 9Stability Study
Lecture 125Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 126Climate Zone
Lecture 127Stability Zone Finder
Lecture 128Stability Studies : Case discussions
Lecture 129Stability Data for Zone IV countries
Lecture 130Accelerated and intermediate testing conditions
Lecture 131Long Term Stability Testing Requirements
Lecture 132Stability Study Protocol Development - Dosage form: Capsule
Lecture 133Stability Data Sheet
Lecture 134Dossier Stability Test
Lecture 135Testing Frequency
Lecture 136Bracketing
Lecture 137Matrixing
Section 10Biopharmaceutical Regulatory Affairs (Innovative Biologics and Biosimilars / Similar Biologics)
Lecture 138Introduction to Biopharmaceuticals
Lecture 139Classification of Biopharmaceutical 
Lecture 140Chemical Drugs Vs. Biologic Drugs
Lecture 141Principle of Naming of Biologic | Understanding on MAB naming system 
Lecture 142Global Biologics Market – By Product
Lecture 143Recombinant protein
Lecture 144Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 145Monoclonal Antibodies
Lecture 146Synthetic Immunomodulators
Lecture 147Production of Monoclonal Antibodies
Lecture 148Cytokines
Lecture 149Interferon
Lecture 150Erythropoiesis-stimulating agent
Lecture 151Biological Licensing Application (BLA) 
Lecture 152Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 153Purple Book: Significance | Searching | Assignments
Lecture 154Vaccine development and approval Process
Lecture 155Biosimilar Development Process
Lecture 156Strategic Consideration for Biosimilar Development 
Lecture 157Bio-Manufacturing Process Information
Lecture 158Studies required for approval of biosimilar
Section 11Pharmacovigilance and Drug Safety
Lecture 159Introduction to Pharmacovigilance
Lecture 160Introduction to Adverse Drug Reactions
Lecture 161ADR: Pharmacology
Lecture 162ADR controversies
Lecture 163ADR: Classification
Lecture 164PV and ADR Monitoring
Lecture 165ADR and Related Terminologies
Lecture 166ADR Reporting System 
Lecture 167DoTS
Lecture 1684 Elements of AEs
Lecture 169ADR Reporting Limitations
Lecture 170ADR Detection - Pre Marketing Vs. Post Marketing Trial
Lecture 171The Adverse Drug Reaction (ADR) Probability Scale
Section 12Pharmacovigilance Process
Lecture 172Pharmacovigilance Process
Lecture 173PSURs
Lecture 174Risk Management
Section 13Pharmacovigilance regulatory authorities
Lecture 175Introduction
Lecture 176United States - USFDA
Lecture 177COSTART
Lecture 178MedDRA
Lecture 179Pharmacovigilance Regulation in Emerging economies, including Latin America
Lecture 180European Union
Lecture 181The World Health Organization (WHO)
Lecture 182WHOART
Lecture 183The International Conference on Harmonization (ICH)
Lecture 184The Council for International Organizations of Medical Sciences (CIOMS)
Lecture 185The International Society of Pharmacovigilance (ISoP)
Lecture 186Active surveillance schemes
Lecture 187EudraLex
Section 14Pharmacovigilance Frame Work
Lecture 188Pharmacovigilance Framework
Lecture 189SmPC / SPC
Lecture 190Pharmacovigilance Software
Lecture 191Good Pharmacovigilance Process (GPVP)
Section 15Add on Learning
Lecture 192Case Study - Pharmacovigilance Frame Work Implementation
Lecture 193Role of Drug Safety Associates