Among its various activities, the R&D Scientific Affairs department is also responsible for collecting and evaluating data from clinical trials, in order to monitor the safety of drug use and identify the necessary actions to support risk management and minimisation. Chiara Godina, Sr. Drug Safety Unit Manager at IBSA, will tell us more about these activities.
Conversation with Chiara Godina, Sr Drug Safety Unit Manager
YOUR JOB TITLE WOULD IMPLY THAT “SAFETY” IS THE KEY WORD IN YOUR JOB…
That’s right, the basic principle is that pharmaceutical companies are responsible for the safety of their products in both the pre-marketing and post-marketing stages. We assess safety in relation to therapeutic effectiveness by evaluating the benefit/risk ratio. The final evaluation is made by the Regulatory Authority during the authorisation phase, but in reality it’s a continuous process within the company, which lasts the entire life of the product.
Before being released on the market, drugs must pass quality and effectiveness tests: pharmaceutical companies must provide safety data – including the side effects observed in clinical studies – and document how the risks will be managed and monitored in the marketing stage. Once the authorisation has been granted, the agencies continue to monitor the quality and the benefit/risk profile of the drug in the approved indications, through the public health systems.
As I said, to all intents and purposes, it’s a continuous process.
AND, MORE SPECIFICALLY, WHAT IS YOUR ROLE?
Within the R&D Scientific Affairs department, I coordinate the activities of the Drug Safety Unit (DSU). The DSU collaborates with the Clinical R&D unit to plan and conduct phase I-III clinical trials – and write the relevant reports – in order to prepare the product’s safety and benefit-risk profile. Indeed, once it enters the market, the product will be used by a wider population than that of clinical trials. At this stage, unexpected adverse effects may be identified occurring at a lower frequency than clinical trials are capable of detecting. So, the continuous collection and evaluation of safety data – i.e. the pharmacovigilance of the medicines I specifically deal with – is essential: it’s the science that allows us to complete the safety profile of medicines, which at the time of authorisation is not yet defined.
The functions of pharmacovigilance are many:
- Detect in a timely manner any unknown adverse reactions or other problems related to the use of the drug
- Quantify (in terms of frequency) the problem identified
- Evaluate the benefit-risk ratio
- Manage the risk through mitigation measures
- Communicate and disseminate the information to healthcare personnel and patients
If IBSA receives a report that a product is indicated as suspicious, the DSU must evaluate the case to determine if the product is actually the cause. All DSU data and assessments are entered into a corporate database, so that all the information is always available for aggregated data analysis on the same or similar events.
Furthermore, the Drug Safety Unit is part of the global pharmacosurveillance system, which aims to monitor the safety of drugs and promptly intervene in the event of new safety signals. If the analysis concludes that there is a causal relationship between the drug and the unknown adverse events, regulatory measures are taken, ranging from the change of the product information (SmPC and PL) to the discontinuation or withdrawal of the medicine itself, if the benefit-risk profile is no longer favourable.
IBSA’S PILLARS ARE PEOPLE, INNOVATION, QUALITY AND RESPONSIBILITY. WHICH AMONG THESE DO YOU FEEL CLOSEST TO YOUR DAILY ACTIVITIES? AND IN WHAT TERMS?
For us, Responsibility is a very concrete term in our daily activity, and has a direct connection with European regulations. Also the term Quality is a very familiar one, since the pharmacovigilance system must meet quality requirements that are defined by the legislation. For us at the Drug Safety Unit, these quality requirements are periodically verified according to performance standards, through internal and external audits. Quality and Responsibility, therefore, are not options or added values, but obligations to be observed.
LOOKING AT THE CHALLENGES OF YOUR DEPARTMENT, WHAT ARE THE ACTIVITIES OR PROJECTS THAT WILL BE DEVELOPED OVER THE NEXT MONTHS/YEARS?
An important challenge is to be ready as soon as the company has a new product, both during the pre-marketing development and the commercialisation. We have the duty to achieve a good knowledge of the pharmacological and medical aspects of the product – be it a medicine or a medical device – for an adequate safety management, which almost always means the ability to evaluate new and unexpected situations.