Ensuring quality is a crucial aspect for a pharmaceutical company, a goal that should be achieved in every activity, first of all clinical research and pharmacovigilance. Iolanda Serica Gessaga is Sr. Clinical & DSU QA Manager at IBSA Group, and today she will tell us what her daily tasks are and how Quality Assurance is closely intertwined with the clinical and R&D activities.
Conversation with Iolanda Serica Gessaga, Sr Clinical & DSU QA Manager at IBSA Group
WHAT DOES YOUR UNIT DO AND HOW ARE YOU ORGANISED?
The Clinical & DSU QA unit was born in 2000 within the R&D Scientific Affairs department. For those not so familiar with this terminology and these acronyms: Clinical indicates the clinical trial area (Clinical Research), DSU stands for Drug Safety Unit, or Pharmacovigilance, while QA stands for Quality Assurance. In actual fact, to some extent this denomination concerns all the areas of competence that the unit deals with.
The function of Clinical & DSU QA – and therefore the focus of my work – is to ensure compliance of clinical studies and Pharmacovigilance activities with regulations and regulatory requirements in force (i.e. Good Clinical Practice – GCP, and Good Pharmacovigilance Practices – GVP). We pursue this goal, for example, through the verification of structured processes, the issuance of internal procedures, the collaboration in risk assessment, the definition of corrective and preventive actions, the monitoring of deviations and the validation of IT systems. Through all these activities, we try to identify the areas that need more attention and to give support to define the (possible) interventions.
Our unit also deals with the maintenance and improvement of the quality system, and with the qualification and requalification of partners and service providers. In fact, relying on suitable partners is essential for the activities of the R&D Scientific Affairs department.
Our team is made up of four people: two are dedicated to Quality Assurance for Pharmacovigilance activities, and two to QA for clinical research activities.
HOW DID THE ACTIVITIES OF YOUR UNIT EVOLVE OVER TIME?
I would say that there has been a significant evolution. Initially, the unit consisted of a single person, who mainly dealt with the issuance of specific SOPs (Standard Operating Procedures), and later also with auditing, that is, verifying that the activities carried out by the department were in compliance with these procedures and regulations. Over the years the unit has grown, giving life to an increasingly structured quality system.
With the introduction of Good Pharmacovigilance Practices (GVP, i.e. the rules regulating Pharmacovigilance activities), IBSA’s initial quality system further evolved, also assuming an ISO-like connotation, as required by regulations, so as to maintain the compliance of the business processes with international standards.
In view of these changes, it has also become essential to equip the Company with additional IT systems, in order to better manage daily activities and regulatory requirements. This led me and my team to become increasingly more involved in the validation of systems, such as Argus, Oracle Clinical, Veeva and TMF.
Finally, I think it is interesting to highlight the increase, over the years, of the audits involving our unit; indeed, they have grown exponentially, together with those that – as Clinical & DSU QA – we carried out on the front line, both within the R&D Scientific Affairs department and outside (i.e. at our affiliates, our distributors, our partners/service providers and the clinical trial centres). This allowed us to acquire the necessary know-how to deal with the regulatory inspections to which we are constantly subjected.
WHAT ROLE DOES THE HUMAN FACTOR PLAY IN YOUR DAILY ACTIVITIES?
I believe that the human factor is critical: everyone’s technical and professional expertise, interpersonal skills and personal attitudes allow to create the synergy that is indispensable when analysing activities and processes in search of solutions or margins for improvement. Earning the trust of colleagues and the people we meet during auditing activities is a challenge that can only be won thanks to a mix of professionalism, helpfulness and spirit of collaboration.
The human factor makes the difference, and I think I can say that in IBSA the dedication of our People to the Company is a reason for pride and joy.