who should attend
The objective of European (EU) Drug Regulatory Affairs course is to provide training on marketing authorization approval in European Union.
EU regulatory affairs course covers recent pharmaceutical regulations, marketing authorization procedure, country specific Common Technical Documents requirement. Moreover, comprehensive ideas are provided on how to prepare drug dossiers as per EU CTD format. Moreover the course focuses on the various marketing authorization pathways. Above all, course briefs on strategic planning for registration of pharmaceutical, biopharmaceuticals in the European Union.
This online course utilizes interactive learning tools to guide each participant through to understand 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. Moreover the course will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work. Above all, the course will also provides hands on training on approval process in detail.
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
- Title of the course: Advance Certification in European Drug Regulatory Affairs.
- Nature of the course: Online self paced learning course. Hence, course can be accessed 24×7, across anywhere.
- Duration of the course: 1 Month.
- Eligibility: Any body who wants to acquire EU drug regulatory affairs competency should attend the course.
- Course certificate : Certificate will be provided at the end of the successful completion of the course.
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 companies, who are handling pharmaceutical business in the European Union.
This European Drug Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand 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, advanced simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advanced learning tools like interactive exercises, reflection questions, and 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 the European Union. Moreover, the course also focuses on Common Technical Documents, guidelines and drug dossier preparations.
- The course is self paced. Hence, courses can be accessed 24×7, anytime, anywhere across the globe.
- Moreover, students can download the course material handed out by login to the dashboard. Hence, it helps them to study offline even after completion of the course.
- Final examination is online. Hence, students can attend the final certification examination at their own convenient date and time.
At Royed Training, we have dedicated International Drug Regulatory Affairs course which covers European Drug Regulatory Affairs course. Executive program in International Drug Regulatory Affairs course covers US, EU, Japan, LATAM, ASEAN, AFRICAN, Middle East / GCC regulation in a single comprehensive course.
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European Drug Regulatory Affairs course covers a range of topics related to regulatory affairs in the pharmaceutical and biotechnology industries in Europe. Here are some common areas and subjects that might be included:
Introduction to Regulatory Affairs:
- Overview of drug development and the role of regulatory affairs.
- Regulatory agencies and authorities in Europe (e.g., EMA – European Medicines Agency).
European Regulatory Strategic Planning:
- Developing regulatory strategies for different stages of drug development
- Regulatory pathways for different types of drugs (e.g., small molecules, biologics, generics, biosimilars).
- Preparing and submitting applications for marketing authorization (MAA) and also variation management.
- Understanding the Common Technical Document (CTD) format, CMC writing and skill enhancer training on submission management process.
Clinical Development and Trials:
- Clinical trial regulations in Europe (e.g., GCP – Good Clinical Practice).
- Investigational Medicinal Product Dossier (IMPD) and Clinical Trial Application (CTA) submissions.
Quality and Manufacturing:
- GMP (Good Manufacturing Practice) regulations and compliance.
- Quality control, quality assurance, and quality management systems.
Pharmacovigilance and Post-Marketing Surveillance:
- Adverse event reporting and pharmacovigilance requirements.
- Risk management plans and post-marketing studies.
Regulatory Updates and Emerging Trends:
- Keeping up with changes in European regulatory guidelines and legislation.
- Exploring emerging trends in regulatory affairs, such as digital health and real-world evidence.
Regulatory Compliance and Inspections:
- Preparing for regulatory inspections and audits.
- Ensuring ongoing compliance with regulatory requirements.