6-Hour Virtual Seminar on EU Regulatory Affairs strategy during development of medicinal products
The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider.
Speaker: Adriaan Fruijtier | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View Details
Pediatric Investigation Plans (PIP) in the EU
The European Medicines Agency plays an important role in the development of medicines for children. In the past, many medicines authorized in Europe were not studied adequately or authorized in children. This caused difficulties for prescribers and pharmacists treating children, as well as for their patients and careers.
Speaker: Adriaan Fruijtier | View Anytime | Price: ¤190.00 | View Details
Scientific Advice in the EU
Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorization application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorization. Following advice from the Regulatory Authorities increases the probability of a positive outcome.
Speaker: Adriaan Fruijtier | View Anytime | Price: ¤190.00 | View Details
Orphan Medicinal Product Designation in the EU
The European Medicines Agency plays a central role in the development and authorization of medicines for rare diseases. These medicines are termed ‘orphan medicines’ in the medical world.
Speaker: Adriaan Fruijtier | View Anytime | Price: ¤190.00 | View Details
Post-approval changes for medicinal products in the EU
This webinar will deal with the many different post-approval changes and describe which procedure has to be followed. Variations are either:
Speaker: Adriaan Fruijtier | View Anytime | Price: ¤190.00 | View Details
The New Clinical Trial Regulation
On 16 April 2014 the new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adopted, and published in the Official Journal on 27 May 2014 (the "Clinical Trials Regulation").
Speaker: Adriaan Fruijtier | View Anytime | Price: ¤146.00 | View Details
Product Information in the EU
In order to obtain a marketing authorization, a Summary of Product Characteristics (SmPC) in accordance with Article 11 of Directive 2001/83/EC must be included in the application. In accordance with Directive 2001/83/EC, when the marketing authorization is issued, the Marketing Authorization Holder shall be informed, by the competent authorities of the Member States concerned, of the SmPC as approved by it. For decisions concerning centralized marketing authorizations, according to Article 10 of Regulation (EC) No 726/2004, the final Commission decision with the SmPC is addressed and notified to the Marketing Authorization Holder.
Speaker: Adriaan Fruijtier | View Anytime | Price: ¤121.00 | View Details
Scientific Advice in the EU
Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorization application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorization. Following advice from the Regulatory Authorities increases the probability of a positive outcome.
Speaker: Adriaan Fruijtier | View Anytime | Price: ¤189.00 | View Details
Regulatory Aspects of Advanced Therapy Medicinal Products in the EU
Advanced therapy medicinal products are human cells and tissues or products with a genetic mode of action; they generate huge expectations but are also associated to new significant threats including tumorigenicity, cell (de)differentiation, and patient integration.
Speaker: Adriaan Fruijtier | View Anytime | Price: ¤189.00 | View Details
The New Clinical Trial Regulation
On 16 April 2014 the new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adopted, and published in the Official Journal on 27 May 2014 (the "Clinical Trials Regulation").
Speaker: Adriaan Fruijtier | View Anytime | Price: ¤189.00 | View Details