*Introduction to regulatory affairs course*

*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 then this course is suitable for you.

*Benefits of this course* • Live online classes and support for participants from anywhere in the world • A comprehensive series of lectures on the fundamentals of regulatory affairs to get you up to track and ready to start work • Course run by an expert teacher with experience working for large pharmaceutical companies and regulatory agencies • Work experience assignments to give you real life regulatory experience. Work is reviewed by our experts and feedback is provided • Support with looking for entry level regulatory affairs positions • CV review to optimise your CV 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. • Gain a certificate upon completion listing the modules covered • Put work experience in CV for assignment work • Covers EU and US regulation

All of this will take you from having no experience in regulatory affairs to getting interviews and a career in regulatory affairs.

For the lecture part of the program, the following topics will be covered: • What is the pharmaceutical industry? • What is regulatory affairs? • What is the role of the regulatory affairs professional? • Background of medicines legislation • Role and structure of the medicines agencies: EMA, FDA and MHRA (JDNA?) • Marketing Authorisation Applications - full, abridged/ generics, hybrid, etc. • EU regulatory procedures • CTD - Module 1, 2, 3, 4, 5 • eCTD • Labelling- SmPc, package leaflet and labels • Clinical data summary (and full*) • Non- clinical summary (and full*) • Quality - chemistry manufacturing and controls • Regulatory strategy • Variations / lifecycle management - EU and FDA • Clinical trial authorisations, IB* • Response to agency questions* • Agency meetings and scientific advice* • Pharmacovigilance and risk management* • Paediatrics* • Orphan drug designation* • Rest of world submissions* • Q and A

*Prices**Option 1* - half lectures, case studies - £465 (introductory offer for first 5 participants) $643

*Option 2* - half lectures, work experience assignments, CV and interview help - £950 (introductory offer for first 5 participants) $1314

*Option 3*- *full lectures, case studies - £950 (introductory offer for first 5 participants) $1314

*Option 4*- *full lectures, case studies, work experience assignments, CV and interview help - £1595 (introductory offer for first 5 participants) $2205

*Case Studies* - Working examples of each topic and how they apply to real life practice. It will give you the opportunity to deal with real world examples during the presentation

*Work Experience Assignments* - You will receive one assignment on each stage of the product lifecycle. This will enable you to gain entry level regulatory affairs experience *Clinical *MAA *Variation *Labelling *Pharmacovigilance, orphan, paediatric or rest of world submissions

*Start date*: 6th September for all options 2nd November for all options

For other dates contact entrytoregulatory@mail.com

Invoice or pay online

*Book a space in the course now. The introductory offer applies only to the first 5 bookings and will increase afterwards. The course will be fully booked once 10 participants are confirmed, so reserve your space now to avoid disappointment.* [Countdown of spaces left on first run of course]

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Contact us for next year start dates or any questions relating to this course

**Although we do our best to keep start dates the same, they are subject to change

The comprehensive topics will allow you to enter a role in regulatory affairs