Anja van Arkens
Anja van Arkens is M.Sc. Pharmacy and has been with Billev Pharma since September 2008 as a Regulatory Affairs Manager. 1 May 2011 Anja van Arkens became partner in Billev Pharma and in May 2015 she took over the position as Managing Director together with Ulrikke Lynge Jensen.
- *More than 16 years of experience from the Danish Medicines Agency as a Quality assessor including:
- -Pharmaceutical-chemical assessment of all types of marketing authorisation and variation applications including human and veterinary products.
- -Member of EMEA Quality Working Party (QWP).
- -Assessor at EDQM for Ph.Eur. certificates (CEP).
- -Laboratory control of medicines and Ph.Eur. draft monograph laboratory testing.
- -Member of EDQM Expert group 10A (elaboration of monographs for synthetic substances).
- *Former course leader at postgraduate courses for pharmacists in marketing authorisation for medicines at Pharmakon.
- *Speaker at various postgraduate courses for pharmacists e.g. stability.
- *Qualified Person for smaller companies. Experience with GMP audits and inspections as well as batch review and review of analytical testing.
- *Trained in and working with GDP.