Dear customers, dear partners, dear friends,
A lot is happening at SCRATCH right now:
As many of you already know, the previous owners of our company, Dr Susanne Kienzle Horn and Dr Renald Hennig, have stepped back from the operational business largely on 1 April 2024 and are now leaving the stage to their – and we can say this with some pride and gratitude – hand-picked successors, namely the two of us:
Dr rer. nat. Rabea Herz and Dr med. vet. Eva Kommas.
As of 1 July 2024, the generation change is now also complete at shareholder level. Even if many of you already know us, we would like to take this opportunity to briefly introduce ourselves officially:
Rabea Herz: I am a pharmacist, married and since January 2023 Managing Director at SCRATCH. I have been working in pharmacovigilance for over 15 years, including six years at a service company for the pharmaceutical industry and seven years at various global pharmaceutical companies. My operational focus is on post-marketing and the vigilance of medical devices.
Eva Kommas: I am a veterinarian, married and since April 2022 Managing Director at SCRATCH. I have also been active in (human) pharmacovigilance for over 15 years, including, much like Rabea, six years at a service provider and then a further seven years at the Federal Institute for Drugs and Medical Devices (BfArM). My operational focus is on clinical studies and audits.
So together we are already pretty strong and know exactly what authorities expect and what can be realised in companies in which ways. We are supported by a great team, which is taking the step into a new era of SCRATCH with us in an unchanged line-up. This is another thing we are proud of and very grateful to our employees for their trust.
SCRATCH is reinventing itself without having to find itself first – that’s great, because it means we can ensure little will change for you, our partners and friends, and that our customers in particular will continue to receive the quality of service they have come to expect from SCRATCH, and to the extent that is necessary. No more and certainly no less.
We are looking forward to (continued) co-operation with you and remain
with kind regards
Rabea Herz
E-Mail: R.Herz@scratch-pv.com
Eva Kommas
E-Mail: E.Kommas@scratch-pv.com
The PV System and its PSMF are essential obligations for any EU Marketing Authorisation Holder.
The QPPV plays THE leading role in EU PV – similar to the Graduated Plan Officer in Germany.
Not optional, not easy to implement: PV Compliance has turned into a continuous burner.
The ’if’ of PV system audits (including all its components) has been answered (yes); the ‘how’ however remains a difficult topic for many of those responsible.
RMPs are needed for nearly every new EU drug marketing authorisation. They are also due with every PV relevant variation. But how do you bring cost efficiency and compliance together?
‘Aggregate Reports’ are about product overview, about a current evaluation of the safety profile and the benefit / risk ratio.
The development of effective, meaningful, and sustainable PVAs is one essential way of dealing with the complexities of a PV system.
PV data from clinical studies are of particular importance for safety profile evaluation: Nowhere else are data of this quality available.
Managing Drug Safety Monitoring Boards, Pharmacovigilance training, Management Coaching, Strategic PV Consultancy and much, much more.