Course details

 

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.

 

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

 

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]

 

Or

 

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