23. SwAPP/sgpm Annual meeting Pharmaceutical Medicine – Data Integrity – How to Trust and Protect Your Data

Information,  programme and photos see here

The symposium started off under a simple title: Data integrity. Two words.
At the end of the day everyone knew how wide and complex the topic is. It concerns the planning of one’s data, the controlling, protecting, maintaining, storing, analysing and sharing of data.
In the introductory talk, it was pointed out that data integrity does not only concern the health care sector, but other areas like financial flows, government data etc.
The next talk was about artificial intelligence, and how important it is to make a system learn the right things – it’s not about the weather, but about recognising the tank behind the tree! The talk also mentioned the challenges of interoperability and data sharing.
In the next talk, there was a change of subjects to pearl necklaces and the challenges of protecting a necklace. The speaker focused on different protection systems and protection levels and on risk management.
The next presentation addressed the regulations, the obligations of the data owners, and touched upon issues that are focused on in audits and inspections.

After a breathtaking piano intermezzo by Mischa Cheung,
the first talk in the afternoon focused on forensic technologies and on what happens if a theft of intellectual property or a breach of data integrity has taken place.
Then the challenges of a highly digitalised country, Estonia, were highlighted and Block Chain technology explained. It was made clear that a block chain is essentially a pin onto which sheets of paper with events are stacked.
The next talk addressed an issue in pharmaceutical medicine, namely medication fraud and medication verification, serialisation and the joint protection initiative.
Finally, the last two presentations focused on patient data: digitalised healthcare, digitalised clinical trial management and recruitment, and digital health consumers as well as the challenges, the willingness and the impact of sharing patient data.

In the name of both associations, SwAPP and sgpm, we thank the speakers for sharing their work, know-how, thoughts and time with us. We also thank the scientific organisers, the chairs and the event organiser. A special thanks to our sponsors. Without them, the symposium would not be possible. And last but not least a thank you to the interested audience for their active participation in the symposium.

Save the date and join us for our next symposium on the last Wednesday in November 2019: November 27, 2019. /ME

EMA: Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products


Revision of the European Pharmacopoeia General Monograph 2619 for Pharmaceutical Preparations which came into effect in January 2018, requires manufacturers of products outside the scope of the General Chapter 5.20 to control the levels of elemental impurities in the products using the principles of risk management. In the case of veterinary medicinal products, the scientific principles on which risk assessment/risk management should be based have not yet been elaborated as the permitted daily exposure (PDE) based approach detailed in General Chapter 5.20 and in ICH Q3D cannot be easily applied to veterinary products.
In order to allow time for regulators to elaborate guidance on the appropriate approach for a risk assessment for a veterinary medicinal product, the CVMP has adopted the following measured approach to the implementation of the monograph to existing veterinary products.

EMA gives guidance on safety monitoring of medicines used in children

EMA has published the new good pharmacovigilance practice (GVP) chapter IV  on specific considerations for the paediatric population. It offers a holistic view of paediatric pharmacovigilance and provides guidance on how to make best use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children. In addition it advises on how to adapt regulatory requirements to the paediatric population in the European Union.