Overview
Overview
European Regulatory Submissions refer to the process of submitting regulatory documentation for a medicinal product to the European Medicines Agency (EMA) and/or National Competent Authorities in order to seek approval for European marketing authorization.
The regulatory submissions process involves the preparation and submission of various documents, such as clinical trial data, quality and manufacturing information, nonclinical data, and pharmacovigilance data. The submission must meet the requirements of the relevant regulations, directives, and guidelines.
The EMA and or National Competent Authorities evaluate the submission to determine whether the medicinal product is safe, effective, and of high quality and whether the benefits of the product outweigh its risks. These parties may also request additional information or clarification before making a decision on approval.
This course is designed to provide an overview of the regulatory and lifecycle management requirements for drugs and biologics in Europe. Students will learn about the product submission process, review existing and new formulas for European regulatory compliance, and required submission documents.
Learning Points:
The regulatory submissions process involves the preparation and submission of various documents, such as clinical trial data, quality and manufacturing information, nonclinical data, and pharmacovigilance data. The submission must meet the requirements of the relevant regulations, directives, and guidelines.
The EMA and or National Competent Authorities evaluate the submission to determine whether the medicinal product is safe, effective, and of high quality and whether the benefits of the product outweigh its risks. These parties may also request additional information or clarification before making a decision on approval.
This course is designed to provide an overview of the regulatory and lifecycle management requirements for drugs and biologics in Europe. Students will learn about the product submission process, review existing and new formulas for European regulatory compliance, and required submission documents.
Learning Points:
- European Regulatory Framework, Overview of EMA and Other Regulatory Bodies
- Pre and Post-Marketing Regulatory Requirements for Drug and Biologics, Medical Devices, as well as Supplements
- Labeling, Advertising and Promotion
- Patents and Exclusivity
- Pricing and Reimbursement
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