InstructorRoyed Training
TypeOnline Course
Price$490 USD / 27500 INR.
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eu regulatory affairs

Introduction

who should attend

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Related Courses

Core Topics

The objective of EU Drug Biologic Medical Device Regulatory Affairs course provides hands on marketing authorization approval and management. This comprehensive course provides participants with a thorough understanding of the regulatory framework governing the development, approval, and marketing of healthcare products in the EU.

EU regulatory affairs course covers recent pharmaceutical regulations, marketing authorization procedure, country specific Common Technical Documents requirement. Moreover, comprehensive ideas are provided on how to prepare drug and medical device dossiers as per EU CTD and EU MDR format. Moreover the course focuses on the various marketing authorization pathways. Above all, course briefs on strategic planning for registration of pharmaceutical, biopharmaceuticals in the European Union.

This online course utilizes interactive learning tools to guide each participant through to understand the EU regulatory structure and ensure that your submissions meet the standards required by the regulators. The course will focus on understanding the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier. Moreover the course will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work. Above all, the course will also provides hands on training on approval process in detail.

The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

Course Snapshot

  • Course Code: RYD-115
  • Title of the course: PG Certification in EU Regulatory Affairs (Drugs, Devices and Medical Devices)
  • Nature of the course: Online self paced learning course. Hence, course can be accessed 24×7, across anywhere.
  • Duration of the course: 1 Year
  • Eligibility: Any body who wants to acquire EU drug regulatory affairs competency should attend the course.
  • Course certificate : Certificate will be provided at the end of the successful completion of the course.

Who should attend?

  • Regulatory Affairs professionals who are seeking to improve their skills in the European Drug Regulatory environment.
  • Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others).
  • Anyone wishing to update their knowledge on European regulatory affairs.
  • Regulatory Affairs, Registration and Documentation assistants/officers/managers.
  • Above all, this course is ideal for the business development managers working in pharmaceutical companies, who are handling pharmaceutical business in the European Union.

This European Drug Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand the regulatory process of the EU pharmaceutical market. This online certification course will focus on understanding regulatory affairs strategic management skills which is required for effective functioning as regulatory personnel. Indeed, advanced simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advanced learning tools like interactive exercises, reflection questions, and expert live chat which makes the course very interesting.

Key features of the course

  • Orientation to practical understanding in the entire drug regulation, registration procedure of the European Union. Moreover, the course also focuses on Common Technical Documents, guidelines and drug dossier preparations.
  • The course is self paced. Hence, courses can be accessed 24×7, anytime, anywhere across the globe.
  • Moreover, students can download the course material handed out by login to the dashboard. Hence, it helps them to study offline even after completion of the course.
  • Final examination is online. Hence, students can attend the final certification examination at their own convenient date and time.

At Royed Training, we have dedicated International Drug Regulatory Affairs course which covers European Drug Regulatory Affairs course. Executive program in International Drug Regulatory Affairs course covers US, EU, Japan, LATAM, ASEAN, AFRICAN, Middle East / GCC regulation in a single comprehensive course.

Few of the similar courses

European Drug Regulatory Affairs course covers a range of topics related to regulatory affairs in the pharmaceutical and biotechnology industries in Europe. Here are some common areas and subjects that might be included:

Introduction to Regulatory Affairs:

  • Overview of drug development and the role of regulatory affairs.
  • Regulatory agencies and authorities in Europe (e.g., EMA – European Medicines Agency).

European Regulatory Strategic Planning:

  • Developing regulatory strategies for different stages of drug development
  • Regulatory pathways for different types of drugs (e.g., small molecules, biologics, generics, biosimilars).

Submissions Training:

  • Preparing and submitting applications for marketing authorization (MAA) and also variation management.
  • Understanding the Common Technical Document (CTD) format, CMC writing and skill enhancer training on submission management process.

Clinical Development and Trials:

  • Clinical trial regulations in Europe (e.g., GCP – Good Clinical Practice).
  • Investigational Medicinal Product Dossier (IMPD) and Clinical Trial Application (CTA) submissions.

Quality and Manufacturing:

  • GMP (Good Manufacturing Practice) regulations and compliance.
  • Quality control, quality assurance, and quality management systems.

Pharmacovigilance and Post-Marketing Surveillance:

  • Adverse event reporting and pharmacovigilance requirements.
  • Risk management plans and post-marketing studies.

Regulatory Updates and Emerging Trends:

  • Keeping up with changes in European regulatory guidelines and legislation.
  • Exploring emerging trends in regulatory affairs, such as digital health and real-world evidence.

Regulatory Compliance and Inspections:

  • Preparing for regulatory inspections and audits.
  • Ensuring ongoing compliance with regulatory requirements.
Section 1EU Regulation
Lecture 1Introduction to EU Regulation 
Lecture 2Orientation to European Countries and National Regulatory Bodies
Lecture 3EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 4Overview of EU Regulation 
Lecture 5EMA and EMA Authorisation Process
Lecture 6EU MA Application Types and Strategic Planning
Lecture 7EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure 
Lecture 8EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 9Validity 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 10Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 11EU Orphan Medicinal Products Regulation
Lecture 12Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 13Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 14Pre-authorisation GMP Inspection
Lecture 15Summary of Product Characteristics 
Lecture 16Compassionate Use
Lecture 17IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 18Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 19EU Prime Designation 
Lecture 20Accelerated assessment by EMEA
Lecture 21EU Adaptive Pathway
Lecture 22European public assessment report (EPAR) - Importance, Component, Management, Updation 
Lecture 23SPOR  - Concept of Master Data Management  
Lecture 24MHRA - UK Regulation 
Lecture 25The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 26Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Lecture 27EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Section 2Clinical Trial & Research
Lecture 28Clinical Trials Terminologies 
Lecture 29Clinical Trial Protocol Writing
Lecture 30Ethics in Clinical Research
Lecture 31Clinical data publication
Lecture 32Clinical Trial Failure: Lack of Efficacy - Case Study
Section 3Dossier Preparation
Lecture 33Introduction to Common Technical Document (CTD)
Lecture 34Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 35Chemistry, Manufacturing & Controls 
Lecture 36Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 37Review Test on Stability Testing 
Lecture 38Importance of effective dossier management
Lecture 39Importance of effective dossier management
Lecture 40Discussion on 85 common deficiency in CTD submission dossier
Lecture 41Key Consideration for Drug Master File Preparation and Submission 
Lecture 42Practical Understanding on Drug Master File Preparation and Submission
Lecture 43Associated Learning: Site Master File - Detailed Understanding 
Lecture 44DMF Completeness Assessment
Lecture 45Drug Master File - Global Perspective [Across Different Regions]
Lecture 46Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 47RTQs | Response to Queries | How to handle Regulatory Queries  
Section 4Pharmacovigilance Program
Lecture 48Introduction to Pharmacovigilance |Definition| Importance |Focus Area | Regulatory compliance | PV activities 
Lecture 49Introduction to ADR | Definition | Importance of ADR management | Classification | Prevention of ADR
Lecture 50Terminologies related to ADR 
Lecture 51ADR Reporting System | ADR information loop | ADR reporting system in various countries
Lecture 52DoTS
Lecture 53PSUR
Lecture 54ADR Seriousness Determination 
Lecture 55How regulatory body adopt PV Program in EU?
Lecture 56PSUR
Section 5Recent Update - Brexit
Section 6Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 58Drug Registration and Submission Strategic Planning for Russia and EAEU region
Lecture 59GMP requirements in Russia 
Section 7Bioequivalence Study
Lecture 60PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 61Bioequivalence Study | Study design | Different types of BE Studies
Lecture 62Bioequivalence 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 63Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 64Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 65Bioequivalence Study - Discussion - Dissolution Testing
Lecture 66Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 8References and General Queries
Lecture 67Comparison of Requirement of Various Regulatory Bodies
Lecture 68Comparison of Dossier Requirements of Europe and US
Lecture 69Comparison of DMF requirement of various regulatory bodies
Section 9EU Regulation for Medical Device
Lecture 70EU MDR Classification
Lecture 71EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 72EU MDR  | Annexes | Key notes
Lecture 73EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 74EU MDR Guideline | EU MDR - Annexes 
Lecture 75EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart 
Lecture 76EU MDR Authorized Representatives | Mandate | Role and Responsibilities 
Section 10Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents 
Lecture 77Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents 
Lecture 78Instruction for Use (IFU) | Design and Development of IFU 
Lecture 79UDI | Different Component | How to design  
Section 11Medical Device Technical File
Lecture 80Medical Device Technical File
Lecture 81Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier 
Lecture 82Quality Management System (QMS) for medical devices company 
Lecture 83Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 84Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File 
Lecture 85Medical Device Essential Principle Checklist | Documentation |  Open file
Lecture 86Implant Card | Regulatory Importance | Content | How to design 
Section 12C-GMP REQUIREMENT FOR MEDICAL DEVICES
Lecture 87c-GMP requirement for medical device
Lecture 88G1 Lecture Premises & Plant Layout Designing
Lecture 89G2 Lecture Sanitation and Hygiene
Lecture 90G3 Lecture Equipment Modules
Lecture 91Production Modules
Lecture 92G5 Lecture Documentation
Lecture 93G6 Lecture Quality Control
Lecture 94Product Complaint
Lecture 95G8 Lecture Storage Module
Lecture 96Product Recall | Product Withdrawal | Handling and Management of Product Recall 
Lecture 97Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 98Documentation | Good Documentation Practices
Lecture 99ISO and ISO Audits
Lecture 100Training on Handling and Management of Data Integrity issues in Pharmaceutical, Biopharmaceutical and Medical Devices Industry
Lecture 101Certification and Legal Requirements for Medical Devices | Conformity Assessment Planning
Section 13CE Marking for medical devices
Lecture 102CE Marking | Introduction | Self Certification | General principles of the CE marking | Manufacturer Responsibilities | Third Party Medical Device Manufacturing & CE Marking | Step By Step CE Marking Process
Lecture 103CE- Self Certification
Lecture 104General principles of the CE marking
Lecture 105Manufacturer Responsibilities
Lecture 106Third Party Medical Device Manufacturing & CE Marking
Lecture 107Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 108Few Common Terminologies used in Medical Devices Industry
Lecture 109Step By Step CE Marking Process
Lecture 110Case studies
Section 14TECHNICAL DOSSIER for Medical Device
Lecture 111Introduction to Medical Devices Technical Documentation
Lecture 112Components of technical documentations
Lecture 113Technical Dossier - Information Required
Section 15ISO 13485 Requirements | Audits
Lecture 114ISO 13485:2016 | Audit Format
Lecture 115Review of customer requirements / customer communication
Section 16MDSAP Training
Lecture 116Introduction to MDSAP | Objective | Significance | Role and responsibilities of stakeholders | Key benefits | MDSAP Process structure and Audit Tasks
Lecture 117QMS and MDSAP | Differences and Similarities | MDSAP Vs. ISO 13485 : Key objectives and differences 
Lecture 118MDSAP Stakeholders 
Lecture 119MDSAP Process Structure Audit Task
Lecture 120MDSAP Document Preparation