Introduction to Regulatory Affairs Course
Introduction to Regulatory Affairs Course
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.
Enrol in the most comprehensive regulatory affairs introductory course available, which includes expert help with your CV and interview preparation.
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, then this course is suitable for you.
This is the most comprehensive 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 world work experience to enhance your skills and support to secure a career in regulatory affairs.
Not only will you benefit from the comprehensive lecture series, but you will also obtain real world experience through case studies and work experience assignments. Furthermore, you will receive support in CV/Resume writing and interview practice to ensure you land your first regulatory affairs role. You will also get the exclusive opportunity to join the community of professionals looking to start a career in regualtory affairs and receive job support throughout the application process.
This course is run by our experts who have considerable experience in pharmaceutical companies and regulatory health authorities. Why not have a look at the sample material below to see what to expect.
Invest in yourself and start your professional journey today
Comprehensive Lecture Series
CV review
Certificate
EU and US Regulations
Job Search Support
Exclusive Community
Live Online Classes
& Recordings
Real World Case Studies
Expert Tutors
Work Experience Assignments
Interview Preparation Practice
23 CPD Hours
Half Course
- 8 CPD Hours of Regulatory Lectures
- EU, UK and US Regulations
- Certificate on Completion
- Real World Case Studies
Full Course
- 18 CPD Hours of Regulatory Lectures
- EU, UK and US Regulations
- Certificate on Completion
- Real World Case Studies
- Work Experience Assignments
- CV Review
- Interview Preparation Practice
- Job Search Support
- Exclusive Professional Community
Start Your Career and Access the April on Demand Recordings
Only 10 Spaces
Full Intro to Reg Course
Register Your Interest, Receive Free Course Material & Get Exclusive Updates
If you are interested in investing in yourself and starting your professional journey in regulatory affairs, fill in the form below to access free course material now and get exclusive information and updates about the course.
Take advantage of this offer and kick-start your career in regulatory affairs.
Sample Videos - Introduction to Regulatory Affairs Course
Sample Videos - Introduction to Regulatory Affairs Course
What is in a Marketing Authorisation Application? Sample Video 2
What is Regulatory Affairs? Sample Video 1
Course Dates
Live Online Webinar Course:
Recording available after live session
The course is held part time over a month.
March 2024 - SOLD OUT
10 participants max
Live webinar on
Saturday and Sunday 5 to 8pm (London Time)
- 16th and 17th March
- 23rd and 24th March
- 30th and 31st March
Recording available after webinar
Work experience assignments will be assigned on non-lecture days between 16th and 31st March and will cover the broad concepts of the course e.g. clinical trials, marketing authorisation applications, variations, labelling and a specialist topic.
Recorded Course:
Full course cohorts:
April 2024
The course is held part time over a month
You will have access to on-demand recordings of all lectures to study at your own pace.
Each week there will be a live Q and A session where we will go through the Case Studies for that week as well as instructions for the work experience assignments.
You will complete a work experience assignments each week that will cover the broad concepts of the course e.g. clinical trials, marketing authorisation applications, variations, labelling and a specialist topic.
July 2024
September 2024
November 2024
Half Course Recordings
The half course recording will be available for viewing on-demand from April 2024. This course can be done at your own pace.
Course Outline / Lecture Programme
For the lecture part of the program, the topics below will be covered. The list is expandable.
Full course students benefit from 23 CPD hours of lectures and half course students benefit from 10 CPD hours of lectures.
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.
The topics which are covered in the half course and full course are not highlighted and the topics that are covered in the full course only are highlighted in yellow.
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
Full Course Details and Lecture Programme
Our Experts have experience in the following organisations
What is Regulatory Affairs?
A profession responsible for the licensing and compliance of medicines to government regulatory standards through submissions to agencies that demonstrate the quality, safety and efficacy of a medicine.
Regulatory affairs professionals are responsible for keeping up to date with legislation and guidelines, ensuring medicines comply with regulatory requirements, authoring and preparing regulatory submissions throughout the lifecycle of a medicine, creating regulatory strategies and managing projects.
Why Regulatory Affairs?
Make a
Difference
Make a difference to the lives of millions of patients across the world who rely on lifesaving medicines.
Make A
Difference
Great Career Prospects
The usual starting salary is
£30-40k.
This rises to £50-70k for managers,
and then increases to
£100k+ as you gain more
experience
Great Career Prospects
Interesting
Professionals gain knowledge of regulations, pharmaceutical science and commercial strategy.
With constantly evolving technology and regulations, there is always something new to learn
Can specialise in a specific area
Interesting
Job Stability
Medicines regulations around the world are increasing.
Increasing regulations means a higher demand for regulatory affairs professionals.
There are many jobs available for experienced professionals
Job Stability
Flexible
Working
Most jobs allow working from home for 2-3 days a week.
Some roles are homebased.
Hours are flexible as long as core hours (10am-3pm) are adhered to.
Part time work is available.
Flexible
Working
Register Your Interest, Receive Free Course Material & Get Exclusive Updates
If you are interested in investing in yourself and starting your professional journey in regulatory affairs, fill in the form below to receive free course material now and get exclusive information and updates about the course.
Take advantage of this offer and kick-start your career in regulatory affairs.