EU Regulation 536/2014 (the Clinical Trials Regulation) established the Clinical Trials Information System (CTIS) as the central platform for clinical trials of medicinal products in the EU. It facilitates the submission, evaluation, and monitoring of clinical trials, while also providing publicly accessible information on approved trials.

Upon completion of a clinical trial, the results must be made available to the authorities and the public in accordance with EU Regulation 536/2014 (Clinical Trials Regulation). The sponsor is required to provide both a scientific summary and a layperson-friendly summary of the results, regardless of the outcome of the clinical trial.

The event's agenda includes various current topics related to patient-centered design and the safe use of medications.

The popular seminar “Scientific Writing and Reviewing in Regulatory Affairs” covers the most important legal requirements for drafting regulatory texts. In addition, participants learn about the importance of a proper process for writing, reviewing, and proofreading in English. The seminar will take place on April 10 and 11, 2018, in Cologne.

Over the course of two conference days, participants will gain a comprehensive understanding of scientific writing and the key regulatory requirements for drafting and reviewing texts. Numerous practical exercises will help participants specifically improve their English writing style. The seminar “Scientific Writing and Reviewing in Regulatory Affairs” will take place on April 3 and 4, 2017, in Frankfurt/Raunheim (Airport).

The expert forum “Product Information and Safe Labeling,” taking place on May 11 and 12, 2016, in Düsseldorf, will focus on the requirements for product information and the safe labeling of pharmaceutical products. Beate Beime, Managing Director, will be a featured speaker on the first day of the conference, addressing the topic of legibility tests and illustrating their practical significance through real-world examples.