Anja van Arkens

E-mail:

Anja van Arkens is M.Sc. Pharmacy and has been with Billev Pharma ApS. since September 2008 as a Regulatory Affairs Manager. 1 May 2011 Anja van Arkens became partner in Billev Pharma. She has more than 16 years of experience from the Danish Medicines Agency as a Quality Assessor:

• 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).
    
• Active member of EGA (European Generic Association) Quality and
  Compliance working group.
• Course leader at postgraduate courses for pharmacists in marketing authorisation for medicines and Stability of medicines at Pharmakon.
• Speaker at various postgraduate courses for pharmacists (Specifications, Impurities and degradation products etc.).

Anne Hjorth

E-mail:

Anne Hjorth is qualified medical secretary and has been with Billev Pharma ApS since January 2009 as Personal assistant to Peter de Mayo Billev as well as assistant to our consultants.

• Has many years of experience working within the pharmaceutical industry and from hospital as well.
• Has experience working as an assistant/secretary with mainly administratively assignments e.g. marketing, proof-reading of medicinal material, clinical trial administration, coordinating meetings and other projects.

Dorthe Bisserup

E-mail:

Dorthe Bisserup has been with Billev Pharma since January 2011 as Regulatory Affairs Associate. She has 17 years experience within the pharmaceutical industry and has worked as QA Secretary, Regulatory Assistant and Regulatory officer.

• Has been working with national, MRP, DCP and CP procedures in the Nordic Countries.
• Works both with human and veterinary medicinal products.

Karen Meldgaard

E-mail:

Karen Meldgaard is M.Sc. Pharmacy and has been with Billev Pharma ApS since December 2008 as a Regulatory Affairs Manager and QP Pharmacovigilance.

She has more than 20 years of experience within Regulatory Affairs and Pharmacovigilance for both human as well as veterinary products dealing with originators as well as generic products.

• Member of EGA /European Generic Association)
  Pharmacovigilance working group.
• Qualified Person for Phamacovigilance (QPPv) 24/7 availability.
• EVWEB reporting of Adverse Drug Reactions (ADR).
• Weekly Literature Searches.
• Line Listing and Signal Generation.
• ADR investigations and handling.
• Periodic Safety Update Report (PSUR) – preparation and submission.

Katja Pečjak

E-mail:

Katja Pečjak is M.Sc. Pharmacy and has been with Billev Pharma East since September 2008 as a Director of Regulatory Affairs. Katja is situated in our
Slovenian office.

• Started her career in the company with veterinary medicines where she has gained experiences with regulatory affairs, quality, sales and promotional activities (lectures for doctors of veterinary surgeons, writes articles for newspapers).
• Afterwards she joined a large generic pharmaceutical company for human medicines where she worked first as a Regulatory Affairs Manager and then as Head of regulatory affairs department. She was responsible for registrations of human medicinal products in Slovenia (generics, well-establish use, traditional herbal medicines), regulatory strategies, launch management, organization of work, establishing new work processes and leadership.
• She is experienced with different regulatory procedures (new applications, renewals, variations) and is working with all European countries.

Majbritt Eichmeier Hansen

E-mail:

Majbritt Eichmeier Hansen is M.Sc. Pharmacy and has been with Billev Pharma ApS since March 2011 as a Regulatory Affairs Manager.

She has more than 10 years experience within Regulatory Affairs for human medicines, active pharmaceutical ingredients and medical devices.

• Has experience with maintenance of national registrations in the Nordics and the centralised procedure.
• Has experience with clinical trials and clinical trial applications.
• Has experience with preparation of Drug Master Files and submission/maintenance procedures within the EU and the US.
• Has experience with CE marking and preparation Technical Files for medical devices.
• Has been a member of regulatory groups of IGL (the Danish Association for Generic Medicinal Products) and APIC (Active Pharmaceutical Ingredients Committee).

Maria Brogaard

E-mail:

Maria Brogaard has a Master degree in Translation and Interpretation and has been with Billev Pharma Aps since June 2004.

• Is a state-authorised translator and interpreter.
• Has 5 year of experience as a medical translator and is involved in national procedures, MRPs, DCP and CPs for both human and veterinary medicinal products.
• Works with all aspects of translation, proof-reading, submission and contact to relevant authorities.
• Performs the function of regulatory assistant which also involves handling of variation applications.

Metka Plečnik

E-mail:

Metka Plečnik is PhD Pharmacy and has been with Billev Pharma East since October 2010 as Regulatory Manager. Metka is situated in our Slovenian office.

• She has 5 years experience as Quality Assurance Manager for GMP and GCP.
• Several years experience in planning, monitoring and conducting of bioequivalence studies as Head of Pharmacokinetic department at large pharmaceutical company.
• She is experienced with different regulatory procedures and pharmacovigilance.
• Has also worked on the applications for pricing and reimbursement.

Mette Skaarup Pedersen

E-mail:

Mette Skaarup Pedersen is M.Sc. in Pharmaceutical sciences and has been with Billev Pharma Aps since September 2008 as a Regulatory Affairs Manager.

• Has experience within Regulatory Affairs and works mainly with DCP, MRP and national procedures in the Nordic and Baltic countries.
• Works both with human and veterinary medicinal products.
  
  
  

Peter de Mayo Billev

E-mail:

Peter de Mayo Billev is M.Sc. Pharmacy and has worked in Regulatory Affairs
since 1963.

• Founder of Billev Pharma ApS in 1978. Sole owner of the company till
  1 May 2011.
• Partner and Managing Director from 1 May 2011.
• Sole owner of Billev Holding, which also includes Billev Pharma East, Slovenia.
• Responsible for strategic planning and international co-operation.
• Active member of European Generic Medicines Association (EGA) since 1995.

Susanne Grøndahl

E-mail:

Susanne Grøndahl is BCom. of Accounting and has been with Billev Pharma ApS
since 1994 as a bookkeeper. She has more than 29 years of experience with:

• Bookkeeping
• Payment of wages
• Reporting to the public sector
• Preparation of accounts to our accountancy firm

Ulrikke Lynge Jensen

E-mail:

Ulrikke Lynge Jensen is M.Sc. Pharmacy and has been with Billev Pharma ApS since March 2008 as a Regulatory Affairs Manager. 1 May 2011 Ulrikke Lynge Jensen became partner in Billev Pharma.

• Has 6 years experience as a Specialist and Head of Section at a Global Danish Pharmaceutical Company handling procedures within and outside the EU.
• Has experience with Regulatory Affairs from a subsidiary handling requirements from the Nordic countries.
• Experience with clinical trials, clinical trial applications and regulatory strategies.
• Has participated in different project groups focusing on the implementation of regulatory requirements in production and QC department and on interaction areas with Regulatory Affairs.
• Speaker at international and national seminars on e-CTD submissions in practice.

Vito Strasberger

E-mail:

Vito Strasberger has been connected to Billev Pharma Aps. since 2006 as our part time IT-development expert. Vito is situated in Slovenia.

• Strongly involved with the Electronic Submissions and Document management systems for regulatory affairs in the pharmaceutical industry since 1996.
• Very good knowledge and understanding of eCTD, Nees and the international regulatory environment related to electronic submissions in regulatory affairs.
  • At present contributing expertise to the European Association of Generic Pharmaceutical producers (EGA) as member of EGA eCTD Working group.
  • Member of the EU RPS (Regulated Product Submission) working group, preparing the standards for the Next Mayor Version of eCTD.
• Specialized in document management solutions in pharmaceutical industry, including requirements for electronic submissions (eCTD) and 21 CFR #11 compliance.