Introduction to Regulatory Affairs Course
- Entry to Regulatory
- Feb 3, 2024
- 9 min read
Updated: Jul 15, 2024
Are you looking for an entry level role in regulatory affairs?
Gain work experience in regulatory affairs even if you are new to this field.
This is the most comprehensive introductory regulatory affairs course available, providing you with a strong foundation in regulatory affairs by increasing your baseline knowledge, as well as offering you the hard to get real work experience to enhance your skills and job search support to secure a career in regulatory affairs.
The comprehensive lecture series covers the detailed regulatory requirements for pharmaceutical products in the EU, US and UK and an introduction to clinical regulatory affairs and medical device regulatory affairs.
In addition, you will obtain the hard to get real world work experience in regulatory affairs through course case studies and work experience assignments that can enhance your CV and improve your skills.
Following completion of the course you will benefit from job search support (CV review, interview preparation and job search support) to ensure you secure your career in regulatory affairs.
By joining you will also be part of an exclusive regulatory professional community that benefits from ongoing advice and support.
This course is run by our experts who have considerable experience in pharmaceutical companies and regulatory health authorities.
Invest in yourself and start your professional journey today.
Course Brochure
Course Details Page:
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Full Course
Half Course
Invest in yourself and change your future
Klarna payment available: i.e. pay in 30 days or pay in 3 installments.
Course Dates
Full Course Dates
16th November 2024 (part time for one month)
On-demand webinar recordings for learning at your own pace with live support if you have any questions. The course is held part time over a month. Each week a new batch of lectures and case studies will be released for you to study that week. You will also be assigned work experience assignments. They will cover the broad concepts of the course e.g. clinical trials, marketing authorisation applications, variations and a specialist topic (e.g. clinical regulatory affairs, medical devices or labelling).
Towards the end of the course you will have the opportunity for your CV to be reviewed by our experts. You will get job search support which involves advice and tips for looking for entry level regulatory roles as well as where to look. Any relevant job postings will be shared. Once you have applied for a role and gained an interview, our experts will carry out a mock interview with you to increase your chance of getting that role.
Other Course Dates
January 2025
Half Course Dates
The half course recording will be available for viewing on-demand from 7th September 2024.
This course can be done at your own pace.
Course Objective
To equip those with no or little regulatory affairs experience with the skills, knowledge and support to get a career in regulatory affairs.
Who is it for?
If you are interested in becoming a regulatory affairs professional but have no experience or if you are working as a regulatory affairs professional but would like to have a strong foundation on the basics of regulatory affairs or expand your knowledge and skills to additional areas then this course is suitable for you.
Benefits of this course
A life changing course that improves your career prospects in regulatory affairs by supporting you to get an entry level role. Experienced regulatory affairs professionals can earn over £100,000 per year.
On-demand recorded classes and live support for participants from anywhere in the world
Comprehensive lecture series of more than 30 CPD hours on the fundamentals of regulatory affairs to get you up to speed and ready to start work
Course run by our experts who have considerable experience in pharmaceutical companies and regulatory health authorities
The only introductory course that covers EU, US and UK pharmaceutical regulatory affairs as well as specialist topics in clinical regulatory affairs, medical devices and pharmacovigilance.
Work experience assignments to give you real life regulatory experience. Work is reviewed by our experts and feedback is provided
Real world case studies in every lecture so you can apply your knowledge straight away
Admission to our exclusive regulatory professional community and ongoing job advice and support. Including, support with looking for entry level regulatory affairs positions
Expert CV review to enhance your CV, stand out from the crowd and increase your chances of getting an interview
Interview preparation practice by live video to ensure you get the job. Run by experienced hiring managers from large pharmaceutical companies.
Receive a certificate and stand out from the crowd.
All of this will take you from having no experience in regulatory affairs to getting interviews and a career in regulatory affairs.
Course Outline / Lecture Programme
For the lecture part of the program, the topics below will be covered. The list is expandable. 30 CPD hours of lectures for full course students and 10+ CPD hours of lectures for half course students.
Note: this list does not include all of the subtopics but is a summary of the subtopics to give you an idea of what you will learn. Each topic is one hour. The subtopics will cover one or numerous slides.
Topics highlighted in yellow below are available for the full course only. Those without a highlight are available for the full and half course.
Welcome and Course Overview Part 1
What is regulatory affairs?
What is this course about?
Your regulatory journey
Course benefits, feedback, tutor experience
Half course vs. full course
What will you learn (detailed)
Welcome and Course Overview Part 2
What experience and skills will you gain?
What Job Support will you get?
Learning portal
Work assignments information
Drug Development and What is Regulatory Affairs?
Medicine types, regulation and history
Drug development process
The role of regulatory affairs
The regulatory framework
Regulatory authority responsibilities and procedures
What is the Role of the Regulatory Affairs Professional?
The regulatory environment
The role of the regulatory affairs professional
Career progression, salary and benefits
The skills and responsibilities needed
Regulatory work that you will be involved in
Real regulatory submission examples
Background of Medicines Legislation - US, EU, UK
The global regulatory environment
The role and structure of the FDA, EMA and MHRA
The standards, legislation and guidance for the US, EU and UK
The laws underpinning US, EU and UK medicines regulation
Regulatory hot topics
EU and UK Regulatory Procedures Part 1
The EU and UK regulatory environment
The phases of a clinical trial
EU clinical trial procedure and timelines
Marketing Authorisation Application procedure and timelines
EMA scientific committees
EU and UK Regulatory Procedures Part 2
The centralised procedure
The decentralised procedure
The mutual recognition procedure
The UK national procedure
The UK international recognition procedure
EU and UK variation procedures
US Regulatory Procedures
The American regulatory environment
US clinical trial procedure and timelines
New drug application procedure and timelines
New drug application assessment
Accelerated procedures
US Post-approval procedures
Regulatory Control of Clinical Trials - EU, US
The laws underpinning EU and US clinical trials
What are the EU and US clinical trial submissions and timelines
What is in the US clinical trial application?
What is in the EU clinical trial application?
How are EU and US clinical trial applications maintained?
Ethics committees role and procedures
EU and UK Marketing Authorisation Applications
Structure and content of the CTD
New Marketing Authorisation Application
Generic application
Biosimilar
Herbal applications
Accelerated procedures
US New Drug Applications
Reference product
Market exclusivity
New drug application
Abbreviated new drug application
Biological and biosimilars
Complementary and alternative medicine
Variations and Lifecycle Management - EU, US
EU and US minor variations
EU and US moderate variations
EU and US major variations
Other variation types
Clinical Regulatory Affairs and Regulatory Writing Part 1
What are the clinical trial phases (detailed)?
What is in the EU and US clinical trial applications?
What is in the IB?
What is in the Clinical Protocol?
Clinical Regulatory Affairs and Regulatory Writing Part 2
What is in the IMPD?
PIPs
The role of clinical regulatory affairs professionals
The role of medical writers
Introduction to Medical Device Regulations - EU, US
Types and classifications of medical devices in the EU and US
EU and US medical device regulations
EU and US medical device regulatory authorities
EU and US medical device registration procedures
Drug device combinations
Introduction to Pharmacovigilance and Risk Management
Pharmacovigilance regulations and regulatory authorities
Adverse reactions, adverse events
Signal detection
Risk management
Post-marketing surveillance
eCTD Content - Introduction and Module 1, Regional Administrative Information
Overview of the CTD contents
Detailed look at Module 1 subsections
eCTD Content - Module 2, Summaries
Detailed look at Module 2 subsections
eCTD Content - Modules 3, Quality, CMC
Detailed look at Module 3 subsections
Drug substance and drug product
eCTD Content - Modules 4 and 5, Non-clinical, Clinical
Detailed look at Module 4 subsections
Detailed look at Module 5 subsections
Labelling of Medicines in the EU and US Part 1
SmPC content
Prescribing Information content
Labelling of Medicines in the EU and US Part 2
Package leaflet content
Package insert content
EU and US label requirements
User testing
Regulatory Strategy
Regulatory strategy in development
Regulatory strategy for MAA submissions
Regulatory strategy for variations
Risk identification and mitigation
Agency interaction
Response to Agency Questions
Types of agency questions
How are responses prepared
Strategies for responding effectively
Common pitfalls to avoid
Learning from feedback
Agency Meetings and Scientific Advice – US, EU, UK
FDA meeting types, timelines and preparation
EMA meeting types, timelines and preparation
MHRA meeting types and preparation
The programme above is the most accurate representation of what will be covered in the course. However, it is subject to change.
Services highlighted in yellow below are available for full course students only. Those without a highlight are available for full and half course students.
Case Studies
Each presentation in the lecture series includes case study scenarios which are discussed in the presentation. These are working examples of each topic and how they apply to real life practice. It will give you the opportunity to apply your knowledge to real world examples during the presentation.
Work Experience Assignments
Course work assignments that will give you real life regulatory work experience. Your assignments will be marked and you will need to complete these to receive your certificate. You will receive one assignment for each stage of the product lifecycle. This will enable you to gain entry level regulatory affairs experience. Work experience assignments covering the following topics will be provided:
Clinical Trials
Marketing Authorisation Applications
Variations
Specialist Topic (e.g. clinical regulatory affairs, medical devices or labelling)
Certificate
A certificate will be provided on completion of the course. The completion of this course can be included in your CV (certifications and training section) and covers 30 CPD hours.
CV Review
At the end of the course, you will update your CV to include this course and the work experience and skills gained. You can submit your CV for expert review and receive detailed feedback to enhance your CV, stand out from the crowd and increase your chances of getting an interview
Interview Preparation Practice
Once you are successful in your job application and gain an interview, you can participate in a mock live video interview with our experienced hiring manager to ensure your interview technique will enable you to get the job. Our experienced hiring managers have extensive experience in recruiting candidates for large pharmaceutical companies.
Exclusive Regulatory Professional Community
Ongoing Job Search Support
Upon signing up to the course you will gain admission into our exclusive regulatory professional community. Here you can socialise, ask questions and receive advice from each other and the course tutor. Within this community you will receive ongoing job advice and support. This Includes support with looking for entry level regulatory affairs positions
Course Tutor Profile
A UK registered pharmacist with around ten years of regulatory affairs experience gained from working in the UK regulatory health authority (MHRA) as an Assessor and several global pharmaceutical companies companies, such as, GSK, MSD and Bayer.
Her experience covers the entire product lifecycle, from clinical trial applications through to new drug applications and post-approval changes. She has worked on various different medicinal products, including biologicals, vaccines, medical device combinations, consumer products (OTC), small molecule and generic medicinal products.
She has successfully delivered multimillion-dollar regulatory approvals and cost savings repeatedly for several pharmaceutical companies throughout the EU, US, UK, and the rest of world markets.
She is passionate about regulatory affairs and providing exceptional regulatory support for pharmaceutical companies to accelerate innovation and deliver for patients. Furthermore, she is passionate about training other regulatory professionals in complex regulatory topics.
Further Information: About Us | Entry to Regulatory
Course Fees
Full Course
Half Course
Invest in yourself and change your future
Klarna payment available: i.e. pay in 30 days or pay in 3 installments.
Feedback
‘I can't recommend this service enough. It is more than just a service, it is life changing. I had many interviews and got my first regulatory affairs job with a medical devices company. Thank you’
Ms. T.A. [Career Change], (Biomedical Sciences Degree)
Role obtained: Regulatory Affairs Officer (Medical Devices), Regulatory Affairs Manager
‘This service is truly exceptional when it came to obtaining a specific job I was pursuing. By the end, I was able to receive multiple job offers. I secured a job with GlaxoSmithKline!’
Mr. H Malik [Graduate], (Pharmaceutical Science Degree)
Role obtained: Project Coordinator (GSK), Quality Assurance Executive
‘I've gained a strong foundation in regulatory affairs, such as CTD structure, MAA change controls, variations and CMC, as well as undertaking work experience. I gained critical skills such as teamwork and effective communication. I feel confident in my interviews’
Ms. S.A. [Undergraduate]. (Biochemistry Degree)
Role obtained: Regulatory Affairs Placement offer form GSK
Book Your space - Start your Regulatory Journey
Book your space in the course now. The full course is limited to 10 -15 participants per cohort due to the assignments that will be given and the job search support. The half course is available on demand for you to view at your convenience. Reserve your space now to avoid disappointment.
Full Course
Half Course
Invest in yourself and change your future
Klarna payment available: i.e. pay in 30 days or pay in 3 installments.
Get in Touch
or use the live chat feature on the website
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