Jakob Sandersen reflects on over a year of regulatory work from S-cubed Pharmaceutical Services ApS based in our Copenhagen Office.
Jakob Sandersen, Director, Regulatory Affairs
We started regulatory affairs and quality assurance activities out of our Copenhagen offices at the end of 2017, to complement the work we have been doing in the UK for the past 10 years. As we have now completed over a year of busy work with existing and new clients, we thought we’d take this opportunity to summarise some of the activities that we have been involved with during 2018 and into 2019.
DMA, Scientific Advice, SME and more
The variety of work has been tremendous and we continue to see increased interest in our services. This is a snap shot of some of the activities we have undertaken out of our Copenhagen office over the last 15 months:
- Danish Medicines Agency advice for clients and attendance at the Scientific Advice meeting. We worked with a client to prepare questions/points for discussion, organised the meeting with the DMA and ensured that action points were identified for follow up activities.
- One of our consultants was based at a client’s site providing GMP & QP consultancy services. This included the creation of a QMS system and writing of relevant SOPs.
- Data Protection Officer (DPO) duties for clients outside of the EU. We continue to act on behalf of clients based outside of the EU, as a DPO for their ongoing clinical studies. This includes dealing with questions from competent authorities and ethics committees, writing/providing input on Data Protection Impact Assessments (DPIA), and attending training courses on GDPR/DPO activities.
- SME registration with the EMA/transfer of OMPs. Due to the situation surrounding Brexit, we have been active in transferring representation for our clients from our UK office to our Danish office, to ensure that our clients continue to benefit from EMA incentives. This also includes EU legal representative status.
- Brexit advice. We have been monitoring the Brexit situation closely, advising clients on issues linked to clinical trial conduct, supply chains, and planning for future activities. We have attended regular EMA events to ensure that we are as up to date as possible (See the articles by Larissa Gould).
- An interesting area that we are working on is the interpretation of new Cannabis legislation in Denmark and monograph surveillance. With recent developments in the use of medicinal cannabis products, we have been fortunate to be involved at this early stage and pleased to be part of ongoing developments. There was an interesting report recently about the European Parliament passing a resolution around medical cannabis. One to watch in the future and we are able to advise in this rapidly developing area.
Veterinary, CTAs, GDPR Advice
We are also involved in a number of other areas to support a variety of clients.
- Danish Veterinary and Food Administration advice regarding the registration of veterinary food supplements.
- Registration for manufacturing/distribution site in Denmark.
- Clinical Trial Applications for Danish clinical trial sites.
- Assistance with Ethics Committee applications/study site liaison in Denmark.
- Regulatory training for clients in Sweden.
- Attended several meetings with Danish Pharmacists Association/Topra/Qualified Person from an authority perspective/Advertising rules by ENLI/latest update serialisation DMVO/Regulatory Science the new trend/Pharmacovigilance Inspection from an authority perspective.
- GDPR advice.
- Review of Site Master File and finished product specification and stability study.
- Project collaborations with UK colleagues from our Oxford offices.
It’s certainly been a very productive and exciting time and continues to grow.
If you require any guidance or advice regarding Regulatory Affairs issues in Denmark or the Nordic region, or would like advice from our UK team, please do not hesitate to contact us.