The updated Therapeutic Products Act, which came into force on 1 January 2019, stipulates that serious, previously unknown or insufficiently described side effects, as well as the non-effect of medicines, must be reported within the legally prescribed period. The reporting obligation for doctors and healthcare professionals is 15 days for serious cases and 60 days for non-serious but nevertheless unexpected side effects.
Quick, vigilant, caring
Since severe cases can be life-threatening, can cause permanent damage or be medically relevant, the highest level of attention and a quick response, vigilance (lat: vigilantia) and care are required here.
This is what we offer the pharmaceutical companies with our TELAG Healthcare team: for two decades, we have not only accompanied selected patients through phase 3, but have also been the interface between the treating physician and the pharmaceutical industry after a drug has been introduced. The cases reported by TELAG Healthcare, among others, are assessed by the pharmaceutical company's experts and, if necessary, forwarded to Swissmedic and the WHO's international pharmacovigilance centre in Uppsala (Uppsala Monitoring Centre UMC).
Every minute is precious here. Early detection protects both patients and pharmaceutical companies and ensures that products are used well and safely.
As certified, external employees of pharmaceutical companies, we are able to take immediate and correct action to avoid adverse events, complaints and consequential damage.We report possible safety or quality problems quickly (within one day) and systematically (certified and pharma-specific audited) to the responsible department in the pharmaceutical company and ensure that they meet their deadlines and the regulatory framework, thus ensuring a high level of patient safety.
In this way, we avert restrictions in the quality of life of patients and, at the same time, high penalty fees for the pharmaceutical companies
In discussion with the doctor or healthcare professional, we document exactly,
- which patient is affected (anonymised according to age, gender, children, pregnant women - if applicable, with information on interactions or findings or laboratory values that have worsened).
- which product is involved
- which side effects/syntoms have occured
and forward the information to a specific e-mail address or fax number so that each step in the process is precisely documented. The pharmaceutical company makes an initial assessment and forwards the assessment to Swissmedic. Here, after a further assessment, the severity is determined and, if necessary, the international UMC is involved.
Closed loop
We not only accompany patients through phase 3, but also inform doctors and medical professionals about new products that can add value to their patients' lives. If a drug does not work as it should in individual cases, we are also there - and play back this valuable feedback immediately. In this way, our TELAG Healthcare Team ensures a closed loop and even more safety by quickly and conscientiously uncovering previously unknown risks.
TELAG Healthcare has been ISO 9001:2015 certified since 1999 and conducts company and pharma-specific audits on an ongoing basis. Pharmaceutical companies value the experience and range of our dedicated team - from market cultivation for new products, ensuring compliance in phase 3 and post-marketing pharmacovigilance. We would be happy to advise you!
Contact: Marianne Kamstra, Key Account Manager, +41 44 276 44 78, marianne.kamstra@telag.ch.
