About This Learning Path
Master the principles and guidelines of the EU centralized drug approval process, from clinical research to marketing authorization, with our comprehensive Clinical Trials and Marketing Authorisations certification. This certification includes courses on clinical trial phases, marketing authorization applications, and the electronic Common Technical Document (eCTD) structure. Gain the expertise needed to navigate regulatory requirements, streamline drug approval submissions, and successfully bring new medicinal products to market in the European Union.
Chapter/Module/Course title:
Course 1: The journey of medicine: from lab to patient in the EU
Description: Explore the EU drug authorization process, covering how new medicines progress from the laboratory to patients. Learn the six steps to achieving marketing authorization and ensuring regulatory compliance.
Course 2: Clinical Trial Phases
Description: Discover the clinical trial phases and understand how new treatments are assessed for safety, efficacy, and effectiveness. Learn about Phases I to IV in clinical research and the key milestones for regulatory approval.
Course 3: Overview of the European Marketing Authorisation Applications
Description: Explore the European Marketing Authorization process and understand the submission requirements and approval procedures for bringing new medicinal products to market in the EU.
Course 4: Electronic Common Technical Document
Description: Learn the structure and required content of the electronic Common Technical Document (eCTD) to efficiently submit pharmaceutical authorizations and ensure regulatory compliance in the EU.
Additional Information
Who should attend:
This course is designed for clinical researchers, regulatory affairs professionals, pharmaceutical project managers, and anyone involved in the drug development and marketing authorization process in the EU.
Certification Duration: Approximately 2 hours
Skill level: Intermediate
Final assessment: Yes (4 quizzes)
Certification associated: Yes
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About This Learning Path
Master the principles and guidelines of the EU centralized drug approval process, from clinical research to marketing authorization, with our comprehensive Clinical Trials and Marketing Authorisations certification. This certification includes courses on clinical trial phases, marketing authorization applications, and the electronic Common Technical Document (eCTD) structure. Gain the expertise needed to navigate regulatory requirements, streamline drug approval submissions, and successfully bring new medicinal products to market in the European Union.
Chapter/Module/Course title:
Course 1: The journey of medicine: from lab to patient in the EU
Description: Explore the EU drug authorization process, covering how new medicines progress from the laboratory to patients. Learn the six steps to achieving marketing authorization and ensuring regulatory compliance.
Course 2: Clinical Trial Phases
Description: Discover the clinical trial phases and understand how new treatments are assessed for safety, efficacy, and effectiveness. Learn about Phases I to IV in clinical research and the key milestones for regulatory approval.
Course 3: Overview of the European Marketing Authorisation Applications
Description: Explore the European Marketing Authorization process and understand the submission requirements and approval procedures for bringing new medicinal products to market in the EU.
Course 4: Electronic Common Technical Document
Description: Learn the structure and required content of the electronic Common Technical Document (eCTD) to efficiently submit pharmaceutical authorizations and ensure regulatory compliance in the EU.
Additional Information
Who should attend:
This course is designed for clinical researchers, regulatory affairs professionals, pharmaceutical project managers, and anyone involved in the drug development and marketing authorization process in the EU.
Certification Duration: Approximately 2 hours
Skill level: Intermediate
Final assessment: Yes (4 quizzes)
Certification associated: Yes
