In recognition of its commitment to research and development, BIAL is an affiliate member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and abides by EFPIA guidelines and regulations in all its R&D activities, as well as all the relevant current International Conference on Harmonization (ICH) guidance documents, protection of patient rights and privacy in each country and generally all regulations and procedures regarding research as they evolve.
In alignment with the five guiding principles established by EFPIA and the Pharmaceutical Research and Manufacturers of America (PhRMA) for the responsible sharing of clinical study data (PDF), BIAL commits to the following:
BIAL undertakes to share, upon request, anonymized patient-level, study-level clinical trial data (analyzable data sets), and other information (such as protocols) from clinical trials in patients for medicines and indications approved in the United States (US) and the European Union (EU), to qualified researchers as necessary for conducting legitimate research.
We are currently updating our internal processes for sharing the above-described data with qualified and scientific researchers. Each request will be evaluated by an independent Scientific Review Board and will be based on criteria that balance the need for scientific development with the need to protect patient privacy.
If you are a medical or scientific researcher interested in obtaining access to such data, kindly email us your name, research affiliation, phone number and email address to firstname.lastname@example.org.
Following approval of a new medicine or new indication for an approved medicine, BIAL will make available the synopses of Clinical Study Reports (CSRs) for clinical studies in patients submitted to regulatory authorities on or after January 1st, 2014. This information will be made available in a redacted form that is consistent with the need to protect patient privacy, publication rights, intellectual property, trade secret and confidential commercial information.
We are working to provide a factual, easy to read, lay-language summary of clinical trial results for those who participated in clinical trials. We will continue to collaborate with academic institutions, industry groups and regulators to establish standards for creating these easy to read summaries to ensure they are useful and informative to patients and healthcare providers.
Please note that the above referred information does not, in any way, replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, Healthcare Professionals should consult the current prescribing information approved in their country. Patients seeking information should consult with their Health Care Professional about the product and the approved written patient information that may be available.
BIAL undertakes to set up all policies and procedures to implement the data sharing commitments as established with EFPIA/PhRMA.
BIAL will continue to register all BIAL-sponsored clinical studies with patients on the public repository, and all trials conducted in the EU on EudraCT and on national registries as required at the country level. Furthermore, BIAL will continue to ensure clinical trial results of all Phase III clinical trials and any trial results of significant importance are submitted for consideration as abstracts during congresses and for publication in peer-reviewed journals, regardless of the results of the study (Pubmed).
BIAL is a signatory of the Transparency Agreement on Animal Research in Portugal. This initiative is supported by the scientific community in collaboration with the EARA - European Animal Research Association to promote openness and transparency about the use of animals in biomedical research across the country.
Animal research plays an essential role in the knowledge of the biological mechanisms that are involved in diseases and in the development of treatments and new therapeutics, where suitable non-animal alternatives are not available.
BIAL actively enforces the Portuguese (Decree-Law no. 113/2013 of the 7th of August) and European laws (Directive 2010/63/EU) that rule the use of animals in research and is actively committed to the principles of the 3Rs - Replacement, Refinement and Reduction.
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