Entries by Agnes Gorecka

Health based exposure limits (HBEL)

DADA Consultancy carries out the evaluation of all available pharmacological and toxicological data, and in concordance with ICH guidelines, constitutes a permitted daily exposure (PDE) report including a clear scientific rationale. Derived threshold values can be used as a risk identification tool and can also be used to justify carry over limits used in cleaning […]

Early Access programs

DADA has experience in planning and applying for Early Access Program authorisations in the BeNeLux. These programs ensure access of clinical trial participants to their successful treatment after finalisation of the clinical trial until marketing of the drug, the compassionate availability of the medicine after MA application but before commercialisation and supply on a per-named-patient […]

Course “CMC Management in Regulatory Affairs – Quality data for marketing authorisation in Europe”

Are you a CMC manager, regulatory affairs manager or a manager of the quality assurance department dealing with the compilation and the maintenance of the Module 3 of the CTD, classification of quality-related changes? FORUM • Institut für Management organizes the course “CMC Management in Regulatory Affairs – Quality data for marketing authorisation in Europe”, […]

Course “Marketing authorisation in Europe for beginners”

Are you working in regulatory affairs or in related departments that need essential European regulatory affairs expertise? Do you need essential European regulatory affairs knowledge? FORUM • Institut für Management organizes the course “Marketing authorisation in Europe for beginners” (19-21 November 2018 in Amsterdam) will inform you about all the important obligations and challenges in […]

Pharmaceutical promotion and compliance

The promotion of pharmaceutical products is strictly regulated on a national level. DADA provides compliance control of promotional activities in the BeNeLux, and as such acts as a Scientific Service. The compliance review is conducted as per the applicable legislation or self-regulation; BeNeLux laws and Codes of Conduct, where necessary complemented by the EFPIA Code or EU […]

CLOSED – Vacancy: Medical Safety Physician Consultant 32 – 40 hrs per week

DADA CONSULTANCY B.V. (www.dada.nl), is a leading, independent and international consultancy in the field of development, registration and quality control of medicines (human and veterinary). DADA is located in a modern office building in Nijmegen and Poland. You will work in a young and enthusiastic team of 26 employees. DADA is characterized by its high […]