Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Impact analysis respective the switch from NtA or CTD submissions (paper or NeeS) to eCTD submissions for medicinal products for human use in the EU being newly applied or already authorized– exemplified for Germany (BfArM) ***

Sandra Rauch (Abschlußjahr: 2014)

Summary
Language: English
The International Conference on Harmonization (ICH) aims to realize rationalized and harmonized regulations for human medicinal products. The Common Technical Document (CTD) and its electronic version, the eCTD, have been developed as a standardized submission format.
Although eCTD submissions for human medicinal products have increased in the last years in Europe, Non-eCTD electronic Submission (NeeS) is still a common format for new Marketing Authorization Applications (MAAs) and also for submissions of variations during life cycle management (LCM).
To have all submissions as new applications, variations or line extensions in an eCTD submission format, a clear Roadmap is necessary. This means a regulatory as well as an internal schedule is appreciated by the companies. With this, the concerned bodies can plan the investment and organizational changes that will become necessary in a defined timeframe.
The scope of this master thesis is to conduct an impact analysis, which should show if a switch from the “old” NtA format in accordance with the requirements of the Notice to Applicants (NtA), Volume 2b, edition 1998 or CTD (Paper or NeeS) to eCTD submissions could be of advantage for a company, whether an MAA in eCTD would be beneficial, for which product(s) this change can be of benefit and to find the best way of implementation.
A project charter must be defined. All influencing factors, such as the starting point, the individual situation of the company, the products and the individual processes and the incentives or advantages of eCTD submissions, need to be considered and analyzed.
This thesis presents a questionnaire that should help to analyze the portfolio and to prioritize the products that should be switched immediately.
Different matrices have been developed (preference, decision and risk analysis matrices) and general ALTERNATIVES, MUST- and WANT-criteria, which companies can adapt according to their own circumstances, are presented. As part of their development, these matrices were tested at an early stage by four users.
These improved tools have been designed to help companies to evaluate their individual needs and to finally make an appropriate and future-oriented decision.
In addition, the decision-making process is illustrated using three fictive examples.
The advantages of the implementation of the decision analysis as evaluated in this thesis are that a clear rational evaluation is possible, measurable sets of facts can be judged easily, it is a time saving procedure if all necessary information can be collected appropriately and a replicable decision finding process is possible.
The disadvantages are that the criteria or collected information must be measurable, emotional and social aspects are not considered and that the decision making is very difficult due to so many aspects which must be taken into account. Each company must consider their own preferences according to their individual circumstances.
While keeping the advantages and disadvantages in mind, the created supporting documents (questionnaire, preference, decision and risk analysis matrix) can facilitate a  decision or make it more transparent and understandable. The tools described in this master thesis can provide decision templates, however the final decision must, of course, be made by the company itself.
Pages: 50,
Annexes: pages: 32