Masterarbeit

Regulatory Intelligence: How public information available in the internet can support a development strategy ***

Annette Fries (2016)

Summary
Language: English
The increasing frequency of global regulatory changes as well as the ever-growing volume and complexity of regulations present a challenge to international pharmaceutical companies as far as keeping up to date is concerned.
Furthermore, many other factors such as the ever–increasing cost of research and development, the need to sustain growth and to develop global pricing and reimbursement strategies, the expansion of competitor medicinal products in the same therapeutic areas, the shorter periods of market exclusivity and the resulting competition from generic drugs contribute to the increasing challenges faced by pharmaceutical companies.
All this leads to the fact that the establishment of Regulatory Intelligence functions has become increasingly important over recent years.
The Regulatory Intelligence function in a pharmaceutical company is far more than the “keeper” of the regulatory landscape. The connected compliance to facilitate the set-up of the most effective regulatory strategy to ensure a smooth marketing authorization process as well as the contribution to decision-making processes by providing data analyses are only a selection of further relevant tasks.
However, because the implementation of a Regulatory Intelligence function and the use of supportive fee-based tools could be a burden to smaller pharmaceutical companies, this master thesis outlines the possibilities of using information available to the public from the internet to support the set-up of a development strategy.
The transparency initiatives from the European Medicines Agency (EMA) and Food and Drug Administration (FDA) concerning transparency of clinical trial data and the information sources covering the entire product-life cycle of a medicinal product made available to the public by EMA/EU-Commission and FDA as well as other regulatory intelligence sources are presented here. Really Simple Syndication (RSS) feeds are introduced as an easy method to keep up to date with regulatory requirement changes as well as the latest published information which is relevant and the use of RSS feed concerning competitor intelligence is addressed. Finally, the use of public accessible sources provided by EMA/European Commission and FDA to support the set-up of a development strategy is outlined based on a case study. The possibilities and limits of using free information available to the public are discussed.
Pages: 40, Annexes: pages: 29