New concept for national scientific advice
The Danish Medicines Agency will soon launch a new national scientific advice concept for companies, hospital researchers and others who require advice on requirements for marketing authorisations or clinical trials.
In June 2016, the Danish government established a growth team for life sciences, whose role was to make recommendations on how to strengthen and promote growth and job creation within the life sciences so that Denmark could become a leading life science nation by 2025. The recommendations from this group are set out in the long awaited growth plan for life sciences that was recently launched on 2 March 2018.
The plan presents 36 separate initiatives within six central areas for improving conditions for life science growth as follows:
- Denmark is an attractive country in which to perform research and development
- More clinical research should be performed in Denmark
- The Danish Medicines Agency should perform as best in class
- Better access to skilled labour
- Improved opportunities for innovators, company start-ups and digitalisation
- Targeted internationalisation efforts
Overall responsibility for follow-up on the growth plan will be based in the Ministry of Industry, Business and Financial Affair's new life science unit, which represents the business policy effort in relation to the life science industry.
Over the last few months, the Danish Medicines Agency has boosted personnel in a number of key areas including biostatistics and pharmacometrics. This now enables us to contribute to the government’s growth plan by launching a new scientific advice service to support sponsors/applicants/marketing authorisation in both human and veterinary areas.
The Danish Medicines Agency will offer advice aimed at exploiting already obtained research results and at future development programs. With time, the concept will be expanded to other areas such as medical devices, precision medicines and GMP advice, which today are not covered by the Danish Medicines Agency’s current legal obligations.
Our goal with this new service is not only to advise in relation to regulatory and legal compliance but to participate in the initial development discussions.
The Danish Medicines Agency currently has advisory expertise within the following areas
- Biostatistics
- Pharmacometrics
- CMC / pharmaceutical issues including biotechnology, biological and radiopharmaceutical
- Clinical trial protocols, including first in human
- Clinical Safety and efficacy over multiple therapeutic areas
- Preclinical aspects of development programmes
- Pharmacovigilance (RMPs, PASS-studies)
- Broadspectrum legal matters in relation to both marketing authorisation approval and clinical trials
Fees
This new service will be subject to a fee commensurate with the type of advice to be provided.
Website
Our website will shortly be updated with more complete information on this new concept, including details on how to apply, fees and a short Q&A.
The concept will be evaluated continuously.
Questions should be directed to Send an email
Link