Thu 30 May 2013 @ 10:59
Zenosis, the leading provider of specialized training solutions for the pharmaceutical industry has announced the release of a new e-course, The Mutual Recognition Procedure (MRP).
- A fresh new interface
- Audio support with animation
- Immersive activities throughout
The Mutual Recognition Procedure is one of three routes available to applicants to gain multinational Marketing Authorisation within the European Economic Area (EEA). A national licence is converted to harmonised licences issued in a number of other member states chosen by the applicant.
The MRP is similar to the Decentralised Procedure but with later involvement of the Concerned Member States in the assessment by the Reference Member State. The Coordination Group for Mutual Recognition and Decentralised Procedures provides guidance and acts to facilitate agreement among the participating states.
This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the MRP.
Wed 22 May 2013 @ 11:04
Zenosis, the leading provider of specialized training solutions for the pharmaceutical industry has announced the release of a new e-course, Electronic Common Technical Document (eCTD).
This 2.5 hour module is an essential tool for regulatory affairs and compliance staff and specialists in data handling, knowledge management or documentation. Project managers and experienced drug development staff who contribute to regulatory submissions will also wish to familiarise themselves with its contents.
This module details the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission.
The eCTD module is an excellent reference and training tool and will assist anyone involved with electronic submissions in navigating these changing requirements.
- Describe the structure, requirements and functionality of the eCTD.
- Outline XML basics and the architecture of the eCTD.
- Discuss Document Type Definitions (DTDs).
- Explain how to build an eCTD.
- Specify regional differences.
- Discuss life cycle and change management.
- List criteria that will make an electronic application technically valid.
- Initiate electronic transfer to a regulatory authority.
- Create, submit and maintain an eCTD dossier throughout the life of a drug product.