Qplus consult: The Pharmaceutical Law Experts
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Qplus consult: The Pharmaceutical Law Experts

Kristina Bindus, CEO, Qplus consultKristina Bindus, CEO “There’s nowhere you can be that isn’t where you’re meant to be...”

If anyone agrees more with John Lennon’s quote, it is Kristina Bindus—an industrial pharmacist. Having garnered nearly three decades of experience in pharmaceutical and healthcare consulting, Kristina has a unique perspective on driving simplification and rigorous compliance, architecting pragmatic solutions and accelerating products to market. Back in the day, as a quality expert, Kristina’s rather rewarding and satisfying job at Baxter—a Fortune 500 American healthcare company—stood her in good stead when it came to auditing at manufacturing sites, distribution sites, warehousing transport companies. She was engrossed in sharing GMP and GDP compliance best-practices with these companies and ensuring the quality of the products was tested meticulously and was compliant with the directives/regulations of specific locations. With her subject matter expertise, she enjoyed contributing insights to deepen the capacity of pharmaceutical organisations and healthcare professionals in making informed decisions over production, distribution and pharmacovigilance.

So, in all, approaching 2010, Kristina had everything going for her—a satisfying job at Baxter, a reputation as a trusted consultant who could manage the complicated relationship between pharmaceutical companies and suppliers, and the respect of her peers.

“Our main goal is safety. We keep in mind the result and deliver the quality services in pharmacovigilance—the formula for our success"

Yet, little did she know that ‘it wasn’t where she was meant to be.’ After being approached by a plethora of different companies for her in-depth knowledge in performing audits for productions sites, finished products, active substances, or raw materials, Kristina was eager to take up fresh challenges. Being a Belgian, Kristina has a penchant for transformation and entrepreneurship. And it was only a matter of time when she quit her job and charted a course entirely of her own making. Qplus consult was thus born.

Enter Qplus consult

The journey of Qplus consult commenced with a mission of helping organisations produce the highest quality products by setting up quality systems and procedures, preparing and passing an inspection successfully, and auditing performance and supplier management. While performing numerous audits at different companies, Kristina was quick to realise that implementing quality systems in pharmaceutical companies for achieving a higher compliant status is as essential as pharmacovigilance. It was a natural progression for Qplus consult to start assisting production plants, distribution centres and supply companies in Belgium and across the globe with their quality management, pharmacovigilance, medical, registration of products, GxP audits clinical research and training requirements.

As a full service and independent consultancy firm, Qplus consult brings to the table years of experience in medicinal products, medical devices, food supplements and cosmetics for supporting clients with GxP and ISO quality management, pharmacovigilance, medical writing, medical communication, regulatory and medical affairs, auditing and training. “Our mission is to help pharmaceutical organisations understand pharmaceutical legislation, good pharmacovigilance practices and related directives and interpret and apply them correctly,” says Kristina, CEO, Qplus Consult.

Qplus consult keeps a close tab on the sea change occurring in the realm of pharmacovigilance. From smarter collection and reporting of safety reports of suspected adverse reactions to the assessment of on market performance of medicines and improved engagement between patients, regulators and healthcare professionals are critical elements. Besides, with COVID-19 disrupting the healthcare sector, Qplus consult acknowledges the impact of the pandemic and the new guidance issued on the management of clinical trials by sponsors and pharmacovigilance systems. Grasping the gravity of the situation, Qplus consult is leading the charge to help its clients to understand the need for being more vigilant and proactive in determining the effects of COVID-19 and changes in authority expectations on safety reporting and patient safety. Kristina believes it is thus more important than ever to have proper information and documentation to conduct trials and postmarketing surveillance.

We educate pharmaceutical organisations on the right interpretation of certain lines of good pharma-covigilance practice module and the right operational application

As a result, Kristina and her team of pharmaceutical law experts are solving one of the long-standing challenges in this sector: correct interpretation and application of pharmaceutical legislation and pharmacovigilance practices. “Often people read legislations, and they interpret them in their way, but it’s not always the right way. As a result, the operational application also suffers. To eliminate this, we educate pharmaceutical organisations on the right interpretation of certain lines of good pharmacovigilance practice module and the right operational application. At Qplus consult, we help clients to understand legislation requirements and how they have to apply those into practice in the jobs, and finally translated them into the record,” adds Kristina. She goes on to mention that understanding of the pharmaceutical legislation and pharmacovigilance concerns the entire organisation. Pharmacovigilance is not just about a single person who receives and handles the cases. Instead, it involves everyone across an organisation—from the top management to the operators to the case handling team.

Covering All grounds in pharmacovigilance

At the core, Qplus consult specializes in pharmacovigilance for human medicinal products, materiovigilance, cosmetovigilance, and nutrivigilance. These vigilance services include everything from receipt, evaluation and reporting of events, reconciliation, quality control, risk management, medical assessment, clinical evaluation reports, to literature search, study setup and follow-up, and report writing. Pharmacovigilance services from Qplus consult have been instrumental in improving the quality of products and increase patient safety.

While materiovigilance services are focused on supporting manufacturers and distributors of medical devices with accurate safety management, cosmetovigilance services from Qplus consult assist cosmetic companies in complying with the regulatory directives. The nutritional vigilance scheme is a monitoring system that aims to improve consumer safety by rapidly identifying potential adverse effects associated with the consumption of food supplements. “When it comes to nutrivigilance, the biggest challenge for pharmaceutical companies is that they need to develop their vision, statements, and standards for handling any reaction that occurs with a potential link to supplements,” stresses Kristina.

Besides, Qplus consult’s vigilance services also comprise adverse event management and expedited reporting to EudraVigilance, pharmacovigilance system and pharmacovigilance system master file (PSMF), global and local literature screening, EU qualified person for pharmacovigilance (QPPV), signal management & EudraVigilance data analysis system (EVDAS) database, risk management plan (RMP) and risk minimisation measures (RMM), periodic safety update report (PSUR), and more.

“We follow a unique approach to pharmacovigilance, which is no more a standalone department within a company. Quality, pharmacovigilance, regulatory affairs, production, customer service, marketing and sales are all interrelated and can influence each other. As a result, we review certain aspects and the type of products the clients have when approached for pharmacovigilance services,” explains Kristina. Looking at the products helps the Qplus consult’s team to understand the client’s pharmacovigilance requirements and assist them in defining their needs. “For instance, if someone needs the procedure for case management, we evaluate their existing procedures for case management. We dig deeper to understand if they need a new procedure for case management or just a change of in the existing procedures. Once we have clearly defined the need, we develop a tailor-made solution, where we explain what the final targets and the timeframe in which we can achieve it are. We also define milestones and deadlines—all these in just one page where the top management visualise every aspect,” she adds.

From educating pharmaceutical companies, Qplus consult conducts various and comprehensive courses, training, e-learning webinars, programs and workshops. The company takes a hands-on approach to educate teams leveraging real-life situations and on the-job requirements.
These interactive learning programs offer certificates at the end of every course.

Correct Scientific Information Saves Lives

Qplus consult also squarely focuses on medical writing and writes all their medical and regulatory documentation. Kristina emphasises the importance of clear, concise and precise medical writing and ensures that her team of medical writers deliver clients with scientific documents and publications that align with relevant and applicable guidelines and standards expected by regulators. In doing so, the team also works closely with clients to abide by their internal procedures and templates. Well-versed in regulatory and medical affairs, experts at Qplus consult specialise in providing reviews, feedback and highly-customised solutions for meeting specific requirements of the clients.



While writing for Regulatory affairs, Qplus consult’s expertise extends to areas like summary of product characteristics, patient information leaflet, company core data sheet, Summary of Clinical Efficacy and Safety, Clinical Overview, Periodic Safety Update Report, Risk Management Plan, Benefit-Risk Assessment Report, among others.

The Patient Information Leaflet developed using the Summary of Product Characteristics (SmPC) and communicated information on the safe use of the medicinal product to the patient. While the authorities must approve the leaflet at the time of marketing authorisation, renewal or variation, Qplus writes leaflets of medicinal products in compliance with all regulatory requirements and yet easily accessible and understandable for the patient.

Knowledge and Quality as a Winning Differentiators

Qplus consult’s proficiency in navigating clients through the labyrinth of pharmacovigilance, medical writing, and medical communication with its services hinges on two imperative factors: knowledge and quality. Kristina believes that the unprecedented experience that Qplus consult brings to the table is a winning differentiator for the company. Besides rich expertise in pharmacovigilance, Qplus consult’s medical writers hail from diverse educational and professional backgrounds, with qualifications in medicine, pharmacy, or life sciences and previous experience in pre-clinical research, clinical laboratory, study coordination, regulatory affairs, data management and scientific writing. Even the instructors have extensive knowledge and ability based on education, experience and occupation in a particular area of study. She illustrates, “It is unrealistic to expect a single person to be an expert in all fields and all tasks about pharmacovigilance. This person surely has the capacities and the knowledge, yet errors in certain processes or pharmacovigilance activities occur. This is where a full-service consulting expert like Qplus enters the picture.”

The power of knowledge at Qplus consult is complemented with the team’s ability to deliver services of the highest quality. As Kristina puts it, quality is the top-most priority at Qplus consult, hundred per cent applicable to pharmacovigilance. “Our main goal is safety. We keep in mind the result and deliver the quality services in pharmacovigilance—the formula for our success,” informs Kristina.

Putting theory into practice demonstrates several successful examples of Qplus consult’s expertise in action. For instance, a local marketing authorisation holder in Belgium sought the services of Qplus consult. The client was working with consultants claiming to have sound knowledge of pharmacovigilance. After an inspection, it was found that their activities were not compliant with the legislation, and they do not understand how to translate legislation into practice. To help fix the situation, Qplus consult began with the gap analysis. The critical problem was taken over by Qplus consult, and within a year, the company tilled compliance to the necessary level. Soon after the client had a follow-up inspection from the authorities, but this time the result was positive. This example illustrates how the marketing authorisation holder, highly responsible for pharmacovigilance need to have the right partner like Qplus consult. “We offered a full 360degree pharmacovigilance services, with knowledge and specialisation,” concludes Kristina.

On a closing note, Qplus consult intends to maintain the lead in the market and continue scripting similar success stories for its clients with its tailor-made solutions and services.
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Top 10 Pharmacovigilance Consulting/Service Companies in Europe - 2020

Company
Qplus consult

Headquarters
Zaventem, Belgium

Management
Kristina Bindus, CEO and Geert Kinnaert, COO

Description
As a full service and independent consultancy firm, Qplus consult brings to the table years of experience in medicinal products, medical devices, food supplements and cosmetics for supporting clients with GxP and ISO quality management, pharmacovigilance, medical writing, medical communication, regulatory and medical affairs, auditing and training. Qplus consult keeps a close tab on the sea change occurring in the realm of pharmacovigilance. From smarter collection and reporting of safety reports of suspected adverse reactions to the assessment of on market performance of medicines and improved engagement between patients, regulators and healthcare professionals are critical elements. At the core, Qplus consult specialises in pharmacovigilance for human medicinal products, materiovigilance, cosmetovigilance, and nutrivigilance

Qplus consult