Introduction to Regulatory Affairs Course

## Introduction to Regulatory Affairs Course

Learn more:
https://www.entrytoregulatory.com/how-to-get-a-job-in-regulatory-affairs

Entry to Regulatory
Advance Regulatory Consulting

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.​
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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.
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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.
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This course is run by our experts who have considerable experience in pharmaceutical companies and regulatory health authorities.

Invest in your self and start your professional journey today

## COURSE BENEFITS

• Live online classes
• Comprehensive series of lectures
• Expert course teachers
• EU and US regulations covered
• Work experience assignments
• Real world case studies
• Job search support
• CV review
• Interview preparation practice
• Certificate awarded
• Stand out from the crowd
• Be part of the community

​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 Series)

For the lecture part of the program, the following topics will be covered:
- Drug development
- What is regulatory affairs?
- What is the role of the regulatory affairs professional?
- Background of medicines legislation: EU, US, UK
- EU regulatory procedures
- US regulatory procedures
- Regulatory control of clinical trials: EU, US
- Marketing Authorisation Applications: EU, US
- Variations/lifecycle management: EU, US
Additional lectures for the full course
- Clinical regulatory affairs and medical writing
- Introduction to medical device regulations
- Introduction to Pharmacovigilance and risk management
- CTD - Module 1, 2, 3, 4, 5
- Labelling- SmPc, package leaflet and labels
- Quality - chemistry manufacturing and controls
- Role and structure of the medicines agencies: EMA, FDA and MHRA
- Regulatory strategy
- Response to agency questions
- Agency meetings and scientific advice: US, EU
- Q&A. Work assignments overview

## 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.
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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​.
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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​.
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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.

Learn more:
https://www.entrytoregulatory.com/how-to-get-a-job-in-regulatory-affairs