San Francisco, California
London, United Kingdom
This in-person training program on documentation, regulation and regulatory affair aspects of medicinal product labelling and packaging in the EU will discuss:
- The SmPC forms and marketing authorisation
- Product Information, Product Characteristics (SmPC), labelling text and package leaflet
- Content approval process and competent authority
- Role of SmPCs in marketing authorisation of all medicines authorised in the European Union and the basis of information for healthcare professionals on how to use a medicine safely and effectively.
- The lifecycle of a medicine
- How the SmPC should be worded (clear and concise language)
- SmPCs and documentation, and information required for patients
- Guidance documents required to pass "user testing" for medicinal product approval in EU
Upon completion of this course, each participant will have a comprehensive knowledge and understanding of development regulatory affairs. Participants will have learned the following:
- Which are the important EU product information guidance documents for the SmPC;
- Which guidelines on the packaging information and excipients are important;
- How to perform consultation with Target Patient Groups
Who will Benefit:
This course is specifically designed for personnel in the pharmaceutical and biotech industries. Following personnel will benefit from the course:
- Regulatory Affairs Officers and Managers
- Labelling and Packaging
- Product Development
- Medical Safety
- Medical Writer
- Quality Assurance/Testing
- Personnel in other departments that need to understand the requirements for Product Information
Product Information consist of the Summary of Product Characteristics (SmPC), labelling text and package leaflet. The SmPC forms an intrinsic and integral part of the marketing authorisation. It sets out the agreed position of the medicinal product as distilled during the assessment process. As such the content cannot be changed except with the approval of the originating competent authority.
SmPCs are a key part of the marketing authorisation of all medicines authorised in the European Union and the basis of information for healthcare professionals on how to use a medicine safely and effectively. They are kept updated throughout the lifecycle of a medicine as new efficacy or safety data emerge. The SmPC should be worded in clear and concise language. SmPCs are also the basis for the preparation of package leaflets, so are important documents in enabling information on medicines to reach patients. This webinar provides advice on the principles of presenting information in the SmPC.
The text on the label and the package leaflet are usually the only items the patient will see from all documents included in a marketing authorization application, so it is very important that the texts are clear and of a high quality. Knowledge of how to write a package leaflet and which guidance documents are important is also vital to pass the so-called "user testing" which is mandatory before a medicinal product can be approved in the EU.
Deviation from the guidelines should be justified in the Marketing Authorisation Applications. This seminar provides an overview of the relevant guidance documents and practical advice of how to write the Product Information.
Note: Use coupon code < NB5SQH8N > and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.