Medicademy’s Module 2, EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation, taking place on September 10 – 12, 2008, at Comwell Borupgaard, Copenhagen, Denmark, still has seats available! In case you are interested in this module, we recommend you to register now or send us an e-mail to make a pre-reservation in order for you to be sure to have a seat! Whereas Module 1, The Pharmaceutical Law Frames in the EU, provides knowledge of the pharmaceutical legislation in EU, Module 2 – ” EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation” focuses on the implementation of this legislation, e.g. on the procedural and operational aspects when applying for marketing authorisations, clinical trials and orphan drug designation in EU. In addition you will learn how to comply with the EU requirements for paediatric investigation plans, risk management plans as well as how to obtain scientific advice from EU. During the 3 days the participants will interact with the expert lecturers and will work with case stories in smaller group sessions to illustrate the necessary considerations for the different types of applications. The module will give you a solid basis for evaluating the opportunities and consequences related to different types of products and submissions and subsequently to plan and operate within the frame work of the various application procedures. Module 2 will also be an essential basis for the modules concentrating in more details on the Quality, Safety and Efficacy aspects or on strategic considerations as well as the modules covering the requirements in other parts of the world.
Author: Administrator Administrator

Medicademy’s Module 7, Non-clinical Development and Documentation, taking place October 6 – 8, 2008, at Comwell Borupgaard, Snekkersten, Denmark, provides the participants with a comprehensive overview of the requirements and critical issues of non-clinical studies to support clinical development and how to build up the Common Technical Document of the non-clinical part of the registration dossier (e.g. CTD module 2 and 4). This module is aimed at regulatory employees who would like to get a better understanding of how to work with the non-clinical part, but also toxicologists could benefit from this module by getting a better understanding of what they should deliver to the regulatory department. The programme concentrates on the development process: How do I select the right studies at the right time to fulfil the company’s needs and the regulatory requirements? How do I evaluate the results? What is the predictive value of the results? What should I know about CMC and clinical development?
Author: Administrator Administrator

Medicademy’s Module 2, EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation, taking place on September 10 – 12, 2008, at Comwell Borupgaard, Copenhagen, Denmark, still has seats available! In case you are interested in this module, we recommend you to register now or send us an e-mail to make a pre-reservation in order for you to be sure to have a seat! Whereas Module 1, The Pharmaceutical Law Frames in the EU, provides knowledge of the pharmaceutical legislation in EU, Module 2 – ” EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation” focuses on the implementation of this legislation, e.g. on the procedural and operational aspects when applying for marketing authorisations, clinical trials and orphan drug designation in EU. In addition you will learn how to comply with the EU requirements for paediatric investigation plans, risk management plans as well as how to obtain scientific advice from EU. During the 3 days the participants will interact with the expert lecturers and will work with case stories in smaller group sessions to illustrate the necessary considerations for the different types of applications. The module will give you a solid basis for evaluating the opportunities and consequences related to different types of products and submissions and subsequently to plan and operate within the frame work of the various application procedures. Module 2 will also be an essential basis for the modules concentrating in more details on the Quality, Safety and Efficacy aspects or on strategic considerations as well as the modules covering the requirements in other parts of the world.
Author: Administrator Administrator