My Background

 

Tina Kjøller, M.Sc. Pharm. from The Royal Danish School of Pharmacy, Copenhagen (“School of Pharmaceutical Sciences” University of Copenhagen).

Postgraduate Diploma in Regulatory Affairs from The University of Wales, Cardiff, UK. Dissertation: “Orphan drug – A comparison of requirements in the different regions of the world”.

Advanced diploma/M.Sc. level, Auditing sterile device manufacturers, University of Manchester, UK.

I have more than 25 years of experience from both large and small companies within the pharmaceutical industry and the device area.

My experience is primarily within international regulatory affairs and I have worked with the following companies: Novo Nordisk A/S, H. Lundbeck A/S, and HemeBiotech A/S (now Zymenex A/S). In addition to regulatory affairs I have experience in the field of new drug products and device development, project management, medical/scientific writing, quality assurance, compliance, and general management.

Activities are listed below, for which I have been responsible, as are therapeutic and product areas in which I have been involved:

My responsibilities have included the following regulatory activities:

  • Regulatory strategies
  • CTA, variations/amendments, responses to information requests
  • IND, amendments og annual reports
  • Application for designation as orphan medicinal product (EU)
  • Orphan product designation application (USA)
  • CTD/NDA, variations/amendments/supplements and annual reports
  • 510(k) applications
  • Preparation of applications and cross reference lists to Notified Body (NB) in relation to the CE marking of devices
  • Drug-device-combination products and certificate of conformity with
  • essential requirements
  • Drug master files
  • International applications
  • International project teams
  • Contact to NB and other authorities
  • Preparation of documentation prior to meetings with authorities (EMEA, FDA, TGA, and EU Member States)

I have been involved in the following therapeutic and product areas:

  • Parenteralia: Insulin drug-device-combination products, recombinant
  • protein rhASA (orphan product under development)
  • Solid dosage forms: hormone replacement therapy, anti conception, epilepsia, neuroleptica,
  • Alzheimer’s/Vascular dementia, HIV, ADHD, dirrhea
  • Gel/patch: hormone replacement therapy smoking ceassion
  • Devices: electronic insulin doser, drug-device-combination products, needles

My responsibilities have included the following quality and compliance activities:

  • Regulatory due diligence
  • The role as Qualified Person (QP) with regard to release of medicinal products imported from counries outside the EU
  • Responsible for import and export of narcotic substances and the annual accounting of these
  • Deviation handling including Root Cause Analysis and CAPA
  • Implementingand updating of quality system
  • Planning, executing, reporting and follow up of GMP and GDP audits
  • Develop/write procedures (SOPs)
  • Document review for regulatory submissions
  • Preparation of report templates

My responsibilities have included the following research & development activities:

  • Project management of recombinant protein rhASA (Orphan Drug)
  • Investigators brochure
  • Edit/review of clinical study protocols and case report forms
  • Edit/review of R&D project reports

I have been responsible for the following management activities:

  • System Administrator for electronic document management system
  • Project management/project team leader
  • General management including salary appraisals and development meetings with up to 20 employees
  • Regulatory & GXP training and development

I have been the Danish delegate in the ISO/TC 209 Clean rooms & associated controlled environments; member of working group 5 clean room operations.

I am a member of the European Regulatory Organisation TOPRA (The Organisation for Professionals in Regulatory Affairs) íts responsibilities include the Diploma and M.Sc. in Regulatory Affairs via the University of Wales. The course consists of 8 modules and a diploma dissertation with the option of an M.Sc. Dissertation.

In addition I am a member of the board of “The Association of Danish Industrial Pharmacists” (IFF, IndustriFarmaceutForeningen).