HOT TOPICS Medical Scientific Information
The seminar provides you with an overview of the current legal situation
- Advertising with results of clinical studies and comparative advertising
- Violation of advertising rules: Legal consequences
- Headquarters vs affiliate: Scientific information management
- Good documentation: A key element of scientific and medical quality assurance
Aims and objectivesOur masterclass will provide you with the
latest news in the field of medical scientific
information, focusing on the most sensitive
aspects of communication regarding medicinal products.
After the seminar, you will:
- know the possibilities and restrictions of advertising with clinical trial results;
- understand the specificity of comparative advertising rules;
- be able to handle patient and specialist enquiries appropriately;
- be able to assure quality through correct medical scientific documentation;
- be capable of managing scientific information between headquarters and affiliates;
- be aware of the legal consequences of non-compliance with advertising regulations.
a basic knowledge of the respective topic.
- scientific service managers;
- product managers;
- medical directors;
- scientific directors; and
- marketing managers
- Scientific data in promotional materials: Under what conditions is advertising with clinical data possible?
- Data from clinical development programmes
- Data from non-interventional studies, patient support programmes, etc.
- Enquiries from healthcare professionals and unsolicited requests
10:45 Coffee break
- What is comparative advertising from a legal point of view?
- Technical and legal requirements to consider when comparing the characteristics of two products.
- Peculiarities of comparative advertising of medicinal products
- Push vs pull information: What information can be provided on request?
- To what extent can you answer questions about competing products?
- Providing information on competing products, e.g. drug comparisons?
- Good documentation of patient enquiries within the company
- Which medical and scientific documents should be archived?
- For how long?
- Who is responsible?
- Ownership of the data
- Documentation of medical questions and enquiries
- Transparency of global promotional material at a local level
- Collaboration in the release of promotional material
- Local, global and joint SOPs
- Possibilities and limits of harmonisation
15:15 Coffee break
- Legal and entrepreneurial risk assessment in the development of advertising material
- Examples of enforcement
- How to handle and minimise risk
17:00 End of seminar
Head Scientific Product Information
Lawyer and Senior Associate; Charlotte Ryckman is a senior associate at the law firm Covington & Burling LLP and assists clients in complex regulatory, legal and procedural life science matters. Her practice focuses on EU rules and the legislation in key EU member states, including Belgium and the Netherlands. Her areas of expertise include pharmaceutical advertising regulations (such as restrictions on off-label communication, contact with healthcare professionals and the sunshine rules, disease awareness campaigns and digital communication) and market access (for example, reimbursement and early access to medicines). Ms Ryckman also advises companies in other life science sectors, including the medical devices and food industries, and has been involved in representing some of these companies in high-profile litigations in Belgium.
Nähere Informationen finden Sie hier.
Nathalie is heading Medical Excellence at Novartis Pharmaceuticals in the Netherlands. After studying medical biology at the University of Utrecht, she started to work as a clinical research associate in the pharmaceutical industry. During her career, she has held many positions in the industry such as Director of Clinical Research, Therapeutic Area Head, Franchise Manager of East and Central Europe. With these different roles she built up expertise in various areas such as medical expert engagement, strategic management, clinical operations, field medical excellence, diversity and inclusion and compliance regulations. In her current role she is responsible for process management of medical functional excellence, medical information and strategic collaboration with market access in bringing new medicines to patients.
NL 1012 Amsterdam
Phone: +31 20 62 12 223
Fax: +31 20 62 75 245
Please send us your questions concerning the seminar topics in advance.
We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.
Please send your questions to Jessica Hüske: email@example.com