Introduction
Course Type
Course Duration
who should attend
Eligibility
Feature
Certification
Related Courses
The objective of European (EU) Drug Regulatory Affairs course is to provide training on Drug Regulatory Affairs and approval process in European Union (EU).
EU regulatory affairs course covers recent pharmaceutical regulations, marketing authorization procedure, country specific Common Technical Documents requirement. Moreover, comprehensive idea is provided how to prepare drug dossier as per EU CTD format. Moreover course focuses on the various marketing authorization pathways. Above all, course briefs on strategic planning for registration of pharmaceutical, biopharmaceutical in European Union.
This online course utilizes interactive learning tools to guide each participant through to understand of the EU regulatory structure and ensure that your submissions meet the standards required by the regulators. The course will focus on understanding the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work.the steps of approval process in details. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
Course Code: RYD-011
Course Title: Advance Certification in European Drug Regulatory Affairs.
Online distance learning course. Hence, course can be accessed 24×7, across anywhere.
1 Month
Who should attend?
- Regulatory Affairs professionals who are seeking to improve their skills in the European Drug Regulatory environment.
- Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others).
- Anyone wishing to update their knowledge on European regulatory affairs.
- Regulatory Affairs, Registration and Documentation assistants/officers/managers.
- Above all, this course is ideal for the business development managers working in pharmaceutical company, who are handling pharmaceutical business in European Union.
Any body who wants to acquire EU drug regulatory affairs competency should attend the course.
This European Drug Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of the EU pharmaceutical market. This online certification course will focus on understanding regulatory affairs strategic management skills which is required for effective functioning as regulatory personnel. Indeed, advance simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advance learning tools like interactive exercises, reflection questions, expert live chat which makes the course very interesting.
Key features of the course
- Orientation to practical understanding in the entire drug regulation, registration procedure of European Union. Moreover, course also focus on Common Technical Documents, guidelines and drug dossier preparations.
- The course is self paced. Hence, course can be accessed 24×7, anytime, anywhere across the globe.
- Moreover, students can download the course material hand out by login to dashboard. Hence, it helps them to study offline even after completion of the course.
- Final examination is online. Hence, student can attend the final certification examination at own convenient date and time.
Certificate will be provided at the end of the successful completion of the course
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