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Berend Ros is Director of the Pharmaceutical services & Consultancy Interdos and member of the Corporate Management Team of Basic Pharma. Interdos consists of the departments Regulatory Affairs, Pharmacovigilance and Quality Assurance, delivering services for the partners of Basic Pharma as well as its own partners. Berend has a medical background (biomedical health science) from the Radboud University (Nijmegen, The Netherlands) and has over 20 years’ experience within the Pharmaceutical business and worked for several international pharmaceutical companies within medical, marketing and sales departments for generic and originator pharmaceutical products. Interdos Pharma was founded in 1997 by Jacques Havermans, and incorporated and a part of in the Basic Pharma Group from the start in 2003 together with Bob Kool. Berend Ros is the successor of Jacques since 2023, the year in which Jacques retired, yet still involved within the company as a consultant.
A calm, reliable, cooperative and communicative Regulatory Affairs Manager with a general microbiology background. At the moment I have almost 15 years of Regulatory Affairs experience for human medicinal products, varying from writing, updating and reviewing eCTD dossiers to coordinating variations, national procedures, MRPs and DCPs. At the same time being the intermediate between client and authority, keeping in mind deadlines and meeting the clients target. After following a few courses several years ago, I have also gained some experience in composing and maintaining CE technical files. In the near future I will expand my RA knowledge regarding the MENA region.
I am a Regulatory Affairs Manager, Pharmacist, with over 12 years of experience in Regulatory Affairs, Pharmaceutical Development and Quality Assurance. After graduation in Pharmaceutical Sciences at Utrecht University, I started my career at Dechra Veterinary Products (2007 – 2015). As a project leader, I managed to develop many veterinary medicinal products and registered them throughout the world in a GMP environment. Furthermore, as a Qualified Person I was responsible for batch release. In the meanwhile, I gained my PhD in Pharmaceutical Sciences (2009 – 2014), where I evaluated the risk of fractures in patients with neurological disorders. I continued my career at Ducares (a TNO initiative) (2015 – 2017), where I co-developed complex analytical methods and cooperated in several projects to enhance human and animal safety. I returned to regulatory affairs at Interchemie werken “De Adelaar” BV (2017 – 2019), being responsible for obtaining and maintaining veterinary registrations worldwide. In June 2019, I started a new challenge at Interdos in human medicine. I would like to describe myself as someone with a strong perseverance, structured, independent, precise and as a strong team player who maintains overview in complex situations. I am looking forward to cooperate with you.
Not long after completing my studies in biotechnology with a master in medical/molecular biotechnology at Wageningen University I started working as an regulatory affairs officer at Interdos. After 9.5 years of working as an RA officer and RA manager, learning and getting experience in the different aspects of regulatory affairs I transferred to my current function of Regulatory Affairs Specialist.
I am a cooperative and enthusiastic Regulatory Affairs Officer with over 15 years of experience in the human pharmaceutical industry. I started as a R&D project assistant at MSD (former Organon) and after several years I made a switch to the Regulatory Affairs department. In this position I coordinated and supported the submission of procedures in Europe. Since May 2015 I work at Interdos Pharma as a Regulatory Affairs Officer. In this position I provide services for our clients, varying from maintaining and updating registration dossiers, management of product information and writing registration dossiers for duplicate registrations. I have a positive and result-oriented nature, together with my wish to support others this makes me a motivated team player.
After several years of working in a research environment (cardiovascular and cancer research) I switched my career in 2014 to the pharmaceutical industry. I gained experience with GMP and worked mainly within a quality assurance department. As of January 1st 2021, I started working for Interdos in a dual role of Regulatory Affairs Support Officer / QA Officer. In my role as QA Officer I will be involved in establishing and maintaining a good Quality management system for Interdos and its partners. As a Regulatory Affairs support officer I will support the team by preparing and submission of registration documents to the local regulatory authorities. I describe myself as an accurate, well organised person. I am used to working in a team, maintaining good relationships with colleagues and customers.
I chose to study Pharmacy by literally pulling the profession from a hat but after completing my Bachelor of Pharmacy at Rhodes University in South Africa and discovering the magic in the science of medicine, I have never looked back.
It is very interesting how a molecule is optimised to transform people’s lives. I find satisfaction and joy in my role in Regulatory Affairs, knowing that I work daily to make quality medicinal treatments available to people.
I have gained experience in new generic product submissions, dossier lifecycle maintenance, SmPC/PIL compilations, change control procedures and artwork compliance in South Africa and other SSA countries by working at various South African generic pharmaceutical companies. My extensive experience together with my passion for regulatory affairs has paved my journey in becoming a part of the strong Interdos regulatory team.
I am Team Lead of the Quality Assurance Department of Interdos Pharma B.V. and qualified as a pharmacist with a Bachelor of Pharmacy and Master in Pharmaceutical Science degree. In addition, a dedicated, detail-oriented, and highly skilled professional with 19 years of experience and expertise in quality assurance, regulatory compliance, and pharmaceutical quality management. I have a proven track record of ensuring compliance with Good Manufacturing Practices (GMP) and Good Distribution Practice (GDP) guidelines and regulatory requirements by demonstrating strong leadership and communication skills, with a focus on maintaining the integrity and quality of medicinal products throughout the supply chain. I enjoy working with our current customers, and I'm eagerly looking forward to the opportunity to collaborate with new customers in the near future, bringing the same level of professionalism and dedication to our partnership.
Beril Tom-de Vries, acquired her medical degree (MD) and worked two years as assistant in training at the department of clinical pharmacology, Ankara University, Turkey. Thereafter, she finalized her thesis (PhD) in cardiovascular pharmacology at the Department of Pharmacology, Erasmus Medical Centre Rotterdam. During this period, she reviewed articles for international journals and gave practical lessons to the students of the medical faculty. In the period between 2004-2009, she worked as medical advisor at Novo Nordisk B.V., in the field of diabetes and growth hormone. As a member of the business team she implemented her medical scientific expertise in marketing strategies. In addition to the routine medical advisor activities, she was an author/ reviewer of (inter)national trial protocols and manager for post-marketing and investigator sponsored trails. She was also responsible for all aspects of product safety. Since 2009, she works at Interdos Pharma as pharmacovigilance consultant and medical-scientific advisor. She is (inter)national trainer and auditor on pharmacovigilance. She is responsible for medical review, signal detection, evaluation and risk/benefit assessment. She is author/reviewer of risk management plans, clinical trial protocols and responsible for development and implementation of the risk minimisation activities and clinical trials.
Daniëlle first studied at the University of Professional Education in Nursing followed by a study in Health Sciences at the Maastricht University. She was a health scientist occupied with Research & Medical Monitoring for more than 11 years. In 2008 she finished her PhD at the Academic Hospital Maastricht. In 2013 she started to work at Basic Pharma as a pharmacovigilance officer, which is in line with her knowledge of health care and analytical skills. The many years of experience in medical monitoring of international clinical trials is useful in her daily work. Her committed attitude makes it very feasible for her to assist in the pharmacovigilance processes; e.g. processing the Individual Case Safety Reports and performing world-wide literature screening. She also enjoys collaboration and supports in the preparation of SOPs, periodic safety reports and signal detection reports.
Carmen Dedic MD completed her studies in General Medicine at the Medical Faculty of Sarajevo, Bosnia and Herzegovina in 2007. As part of her GP certification, she completed a year of practical experience at the Sarajevo Hospital. From 2009-2011, Carmen worked in a primary healthcare team providing care to patients with a wide range of illnesses, ranging from routine to emergency cases. Through this experience, she gained knowledge, skills, and experience working with patients from pediatric to geriatric age. While completing a residency program at the Clinic of Pediatric Surgery in Sarajevo from 2011-2018, she treated routine as well as rare cases in pediatric surgery. During this time, she deepened her knowledge of congenital neonatal and pediatric urology surgeries to find the least invasive treatment for a child’s medical problem. In 2018, she received her Pediatric Surgeon qualification from the University Clinic Sarajevo. As a medical professional, Carmen has been an active participant in medical workshops and congresses in the field. Throughout her healthcare career, she developed her clinical skills, medical judgment, and teamwork abilities. Joining Interdos in November 2020 as a Medical Advisor, Carmen is looking forward to apply and share previously gained knowledge and experience with colleagues in pharmacovigilance.
Lubena studied Medical Health Sciences with a background in biomedical and molecular research. In 2006 she started at the Regulatory Affairs department of Interdos. After a few years she made the switch to the Pharmacovigilance department. Her biomedical background is useful in her daily Pharmacovigilance activities that she performs. Her activities include performing world-wide literature screening, processing the Individual Case Safety Reports, collaboration and support in the preparation of periodic safety update reports, signal detection reports and the submission of XEVMPDs (Extended Eudravigilance Medicinal Product Dictionaries).
I am a qualified epidemiologist with a Master’s degree in Epidemiology. During my studies, I gained theoretical knowledge on research design and implementation, statistical analyses and critically evaluating scientific publications on public health and patient-bound research. Moreover, during my 12-week placement and thesis period, I gained experience with scientific writing, scientific results presentation, project management and professional skill acquisition. I started at Interdos in August 2022 as a junior pharmacovigilance officer. My responsibilities include global and local literature screening, processing Individual Case Safety Reports and SDEA management. I am excited to be a part of the Interdos team and look forward to expanding my knowledge in the field of pharmacovigilance.
Joep (Msc) completed a bachelor in applied science after which he worked in several hospital laboratories. He gained experience in hematology, genetics and leukemia research before graduating with a master’s degree in Medical Science from Uppsala University (Sweden). Since 2022, Joep added a new chapter to his career by taking on a job offer as Pharmacovigilance officer for Interdos.
‘’Interdos allows me to focus on an interesting field, the safety of medication. Apart from that I enjoy working in this international environment in which everyone is dedicated to the task at hand.’’
Joep is eager to put his previous working experience and knowledge to good use and work hard, in order to improve Interdos and the services Interdos provides for its customers.
Esthelle has completed a Bachelor’s and Master’s degree in Biomedical Sciences at Maastricht University, with a specialisation in Regenerative Medicine. Here, she acquired valuable knowledge in the biological processes behind human life and mechanisms behind medicines and diseases. During her internships, she gained research experience in clinical trials and laboratory activities, including cell culture, wetlab techniques as well as handling live cell and slidescanner microscopes. She is now embarking on a career in pharmacovigilance, where she can apply her knowledge and skills to ensure the safety and efficacy of pharmaceutical products, starting as a junior pharmacovigilance officer and medical advisor at Interdos in October 2023.
Robin completed his research master in drug development and neurohealth at Maastricht University. He has extensive theoretical knowledge in neuropsychiatric and neurological disorders spanning from molecular mechanisms to clinical manifestations, with a particular interest in neurodegenerative diseases. Moreover, he has gained research experience in drug development and repurposing focused on clinical trials and preclinical research methods.
Robin joined the pharmacovigilance department of Interdos in 2023. He is determined to implement his knowledge and skills in order to guarantee the safety of pharmaceutical products for patients in need.
My name is Roel Faut, I studied molecular Biology and Biochemistry and am involved in several QA roles for the last 7 years. That is manufacturing Pharma, medical wholesale, cell and gene therapy and now, I am a senior QA officer and RP for several of Interdos' clients. It is exciting to work in the high paced pharma industry, dealing with customers, performing on-site audits and provide the Interdos clients with a solid PQS.
My interest in the functioning of human health led me to study Pharmacy at the University of Santiago de Compostela in Galicia, Spain. Simultaneously, after working in a community pharmacy, I decided to enhance my knowledge following a Master's degree in Pharmaceutical Industry in Barcelona. Since then I have had the opportunity to put my knowledge and skills into practice in multiple quality departments at several pharmaceutical companies in Spain and the Netherlands. As from May 2023, the next phase of my career started at Interdos as Senior Quality Assurance Officer. Furthermore, I consider myself as an accurate and adaptable person.