Tired of getting slowed down by Regulatory?
Stop fighting regulatory, start understanding their process!

Expand your regulatory affairs knowledge with our comprehensive course.
Our course is designed for beginners in regulatory affairs - whether you are straight out of Uni or working in R&D and want to expand your regulatory knowledge.
Dealing with the Regulatory Affairs department and their requirements often can be cumbersome and frustrating. Sometimes it feels like it slows down processes and creates more work at the best of days and breaking the project at the worst.
Yet most Regulatory employees don´t wake up every morning scheming to make your life miserable. In fact, they are also experiencing massive frustrations with a breakdown in communication and being constantly misunderstood. They need to obey specific rules and regulations that people outside of RA often tend to ignore.
When there is shared understanding the limitations get smaller and the possibilities bigger. This course won´t make you an RA expert and it won´t get rid of all of your frustrations but it will make your interactions with RA much more focused, logical and solution oriented.

In this course you'll learn about:

Clinical Data

When you need Clinical Data and how to get them - and how they might actually help you

Biocompatibility

How to ensure that Biocompatibility Assessment is not going to slow you down later

Notifed Body File Review

What do reviewers look for

And many more... 
Check the full list of course contents below.

The course for anyone...

Engineering

You did it. You created the perpetuum mobile. You solved the unsolvable task. You are high on emotions and on top of the world. Only for a small mail from RA to shatter your world. “It can´t be used like this!”.
The solution was big the frustration even bigger. Frustrated you complain about RA to your colleagues but what’s the point?
Understanding the RA process and line of though early on is key to ensuring a smooth development process. If you have better knowledge about the process, you can challenge wrong constrictions and acknowledge the real constrictions early in the process. It won´t be smooth sailing from here on out but at least now you know when to involve them and how to speak to them. Rather than you fixing a problem just to be told that this was the wrong way to fix it you can tackle the constrictions early on instead of after you have done all the work.

Marketing 

Your product has such amazing features, and RA forbids you from using any of them in your communication. You feel like you are shackled to the ground and brought a spoon to a gunfight while your best weapon is just next to you, but: you aren´t allowed to use it.
Understanding the RA process and line of though helps you to integrate marketing needs early on in development and testing and utilizing all possibilities to be able to use the best marketing messages you legally can.

Project Management 

You built the timeline, aligned stakeholders, mitigated risks, and everything is finally on track. Milestones are being hit, expectations are managed, and for once nothing seems to be on fire. Then comes the message from Regulatory: additional requirements, missing documentation, or a process that needs to be revisited. Suddenly, your carefully crafted plan starts to shift.

Regulatory input often feels like it appears late and disrupts progress, but in reality, it follows its own structured processes and constraints. Understanding how Regulatory Affairs operates allows you to anticipate their needs earlier, integrate their requirements into your planning, and avoid last-minute surprises. By involving them at the right time and speaking their language, you can turn potential roadblocks into manageable checkpoints - keeping your project on track instead of constantly readjusting it.

Product Management 

For the first time ever marketing doesn’t bother you with requests you deem unnecessary, Sales is not challenging your timeline and pricing, even production runs smoothly. You are at the lottery vendor as today is THE day. You hear a ping on your iPhone and see a mail from RA on your screen. You tear up your paper. You celebrated too early.

Regulatory requirements often come in too late and put a dent in your step. Not because they want to steal your thunder like the Grinch wants to steal Christmas, but because these are the rules and regulations. Understand what they need from you so that you can find common ground and solve problems when they are still easy to fix and before they become catastrophic.

Designed by experts, priced for accessibility

Because education should be within everyone’s reach.

Students / Young Professionals

Within two years of graduation.
200 EUR* (early bird) 
250 EUR* (after April 28th)
* plus VAT

Self funded

250 EUR* (early bird) 
300 EUR* (after April 28th)
* plus VAT

Corporate

With VAT Invoice
500 EUR* (early bird) 
750 EUR* (after April 28th)
* plus VAT

Expert-built, thoughtfully designed for beginners.

We have gathered experts with years of hands-on experience to create a course to give you the understanding you need to start your career in regulatory affairs. This is a deep dive for anyone who want to know more about regulatory affairs and those who have to.

  • The #1 Course to land a job in regulatory affairs

  • All necessary knowledge areas are included
  • 14 webinars led by 8+ seasoned experts, delivering practical, real-world insights you can trust.

  • 2 Sessions per week, allowing ample time for knowledge to fully absorb.

  • Starts May 11th

  • Recordings available for 6 months

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2,345 Feedback from Our Courses

„Excellent speakers, interesting discussions, fun and great atmosphere.“
    
„It is a very interesting and informative course, excellent trainers/speakers.“
     
"Your initiative is inspiring, with a great delivery and perfect timing. The team is welcoming and shows a very serious intent to find and propose ways of sailing through the realities imposed by
the MDR and its implementation..."
    

Start your Regulatory Affairs journey today

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