The future of pharmacovigilance - our perspective on global changes
The landscape of pharmacovigilance regulations is constantly changing and shifting towards higher levels of compliance and quality.
To keep up with these changes, we always look ahead and try to anticipate what the future brings to our daily pharmacovigilance activities.
The key impacts on global pharmacovigilance systems
Global pharmacovigilance systems are changing significantly due to technological advancements, increasing volumes of data available to regulators and companies, and the increasing engagement of patients in healthcare decision-making.
Within pharmacovigilance and regulatory compliance, pharma companies are constantly dealing with a growing heap of changes—more data from more sources, more products in more locations, and ever-changing reporting requirements.
These changes lead to an increase in pressure to analyze more data as quickly as possible, monitor risks more broadly, and accurately report adverse events across the globe.
We believe that the key elements of pharmacovigilance in the future will be smarter collection and safety reporting of suspected adverse reactions, measurement of on-market performance of medicines, and improved engagement between regulators, patients, and healthcare professionals.
How technology supports pharmacovigilance
Digital processes are constantly being revolutionized, enhancing at a startling pace.
Technology will support pharmacovigilance compliance processes in ways that were inconceivable a few years ago, which will be indispensable for workflows of all pharma companies.
Embracing technologies like cloud-based solutions, mobile applications, and technology for big data analytics will further help companies to move towards greater automation of the pharmacovigilance system.
However, no matter how much we rely on digital innovation to increase our efficiency, we believe that the most important factor in any pharmacovigilance process is the professional handling of work. Whatever the future of technology brings, quality and compliance will always depend on the judgment and expertise of the person behind the screen.
Pharmacovigilance and COVID-19
The role of pharmacovigilance in the COVID-19 pandemic is undeniably important. At the moment, the major focus is on monitoring and analyzing the safety of COVID-19 vaccines, as well as medicinal products used in the treatment of the disease caused by SARS-CoV-2.
The goal of vaccine pharmacovigilance is the early detection and timely response to adverse reactions that can occur after immunization. This minimizes the negative impact on individuals’ health and reduces the potentially negative impact on the immunization of the general population.
Pharmacovigilance system experts are responsible for identifying the risks of medicinal product or vaccine use. They ensure that necessary risk management measures are taken, and that all participants in the system are involved in risk-related communication.
The growing role of CROs in drug development
The vital role of contract research organizations (CRO) in helping pharma and biopharma companies in the European Union address current complex drug development challenges has considerably grown over the past few years.
Today, sponsors throughout the EU are increasingly engaging CROs to provide data-driven insights and navigate the changing drug development landscape for the next generation of medicines.
However, even with the latest technologies to back their business initiatives, pharma companies need a reliable consulting partner that can support them in their health product’s life-cycle from development to regulatory compliance.
This is where Marti Farm serves as a partner of choice through its exceptional range of consultancy and regulatory services.
Our vision of the future
With a proven track record of 10+ years, our core belief lies with continuous personal development and strengthening of our expertise in order to drive added value for clients from both the operational and strategic aspects.
Our pharmacovigilance department consists of highly educated, professional, and compliant staff with the necessary organizational and technical support to meet the individual needs of clients, all in compliance with the legislation of the relevant country.
At Marti Farm, we see the quality management system of CROs as the cornerstone of compliance and professionalism. We believe that CROs should base all their services and capabilities on expertise, education, and experience in order to be able to provide clients with prompt and safe clinical resource management.
The digital innovation that propels our daily pharmacovigilance tasks
Not only have we developed a system for performing pharmacovigilance activities at the local and global level, but also our own in-house safety database called Sympto. It is designed in particular to minimize risk and facilitate the detection of potential signals.
Through an end-to-end, fully integrated solution, Sympto enables pharmacovigilance teams to perform all operational pharmacovigilance activities, make submissions, screen literature, and collaborate with their team in one easy-to-use interface.
Through their experience, our pharmacovigilance experts realized that Sympto is competitive to other safety databases due to its enhanced user-friendliness and the fact that it provides resources essential for better preparation in audits, inspections, and also for identifying and minimizing errors.
This fully validated and user-friendly product is ideal for pharmacovigilance and cosmetovigilance, and is integrated with EMA and FDA gateway for factual reporting.
With the help of Sympto, Marti Farm’s pharmacovigilance team effectively provides case processing and medical writing of documents such as DSURs, PSURs, and line listings that cover the safety summary of medicinal products during their clinical trial testing phase.
Our pharmacovigilance team has processed over 144 593 literature entries in the Sympto database, and distributed over 2293 activity reports for clients as part of monthly reconciliation. Over 10000 ICSRs have been submitted and processed through Sympto so far.
Sympto has also proven its value during the ongoing COVID-19 pandemic. We were able to keep our workflows intact during the shift to remote work thanks to its functionalities. In its core, Sympto is a communication platform that nurtures teamwork, even when we’re not in the office. Its flexibility allowed us to carry on with our daily activities in face of the pandemic and two devastating earthquakes.
Who knows what the future holds
Everyone can agree that this decade was off to a rough start, in all aspects of our lives. There was no industry or sector that wasn’t affected by the global challenges emerging as a result of unexpected threats and hazards.
Now, we are more prepared than ever before to face the unexpected. We are yet to see the full impact the pandemic will have in the following years, but we are proud of the endurance and adaptability we have demonstrated until now. Thanks to the evolution of our digital innovation, our resilient BCP, and our closely-knit team of professionals, we are ready to face whatever the future holds for us.
Lucija Bedeniković, MPharm / Senior Pharmacovigilance Associate | Deputy Head of Pharmacovigilance Department | Medical Reviewer | Medical Writer
Lašćinska cesta 40
Planinska ulica 13/2
Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
Tel: +385 1 5588 297
Full company name
Short company name
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)