These one-day programs offer invaluable overviews of the regulatory profession in the US, Canada, the European Union (EU) or Japan. Or you can improve your technical writing skills in the Effective Medical Writing workshop or learn about the Role of the Authorised Representative in this new workshop.

These workshops are beneficial for professionals new to regulatory or shifting product lines. Expand your knowledge, learn about a new region or prepare for the fall RAC exams!
(Separate registration and payment required)

View detailed workshop topics and speakers!

Regulatory Essentials: Canada
This workshop, filled with activities, open discussion and case studies, will provide regulatory professionals with an essential overview of current regulations and policies affecting the Canadian regulatory profession. This course is beneficial for professionals new to regulatory or shifting product lines, as well as for those preparing for the RAC (CAN) exam.

Regulatory Essentials: EU
This workshop will provide an all-inclusive overview of the regulations and policies affecting the EU regulatory profession. The workshop will be particularly beneficial to those new to regulatory or shifting product lines, as well as for those preparing for the RAC (EU) exam.

Regulatory Essentials: US
This workshop will feature a comprehensive overview of the regulations and policies affecting the US regulatory profession. This course is beneficial to those new to regulatory and shifting product lines, as well as for those preparing for the RAC (US) Exam.

Regulatory Essentials: Japan
Within recent months, Japan’s regulatory environment has undergone significant changes, developments and advancements. To learn about these developments through open discussions, case studies and specialty work stations designed to target specific questions and concerns, you will get a once-in-a-lifetime opportunity to network with and pose questions of distinguished experts, including Japan’s government officials and department heads from PMDA and MHLW.

Effective Medical Writing
Medical writing is an integral part of a product’s development and approval process, impacting submissions and supporting compliance. Types of regulatory documents include protocols, clinical study reports (CSRs), investigator’s brochures, investigational and product applications and many other critical documents. During this workshop, you will hear the Do’s and Don’ts of composing regulatory documents and learn practical techniques for improving the quality of your writing. You will also learn tips for streamlining the preparation and review processes to efficiently create your regulatory documents.

Role of the Authorised Representative in the EU Medical Device Market––NEW!
This workshop will introduce the role of the Authorised Representative in European regulatory compliance with requirements for medical devices. Representatives from the European Association of Authorised Representatives (EAAR) will review key compliance issues, provide an update on the latest developments and explain the role of the Authorised Representative in each area of compliance. This workshop is beneficial to those in small- to medium-sized medical device companies considering entering the European market.