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Jacques Havermans is industrial pharmacist and Qualified Person. He worked for the generic company Lepharma/Sudco for 12 years and started his own consultancy company, Interdos Pharma, in 1997. In 2003 he has founded the Basic Pharma Group together with Bob Kool. Interdos Pharma was incorporated in the Basic Pharma Group from the start. He is member of the management board of the Basic Pharma Group and Qualified Person for Basic Pharma and various other pharmaceutical companies.
With a background in molecular life sciences (bachelor’s degree) and a specialization in cardiovascular biology & medicine (research master) I gained three years of experience in an R&D setting. I spent two years working on the development of diagnostic tools for Lyme Disease and Aerotox syndrome, followed by one year of research on cultured meat. I switched my career to Regulatory Affairs back in 2015, when I started at Interchemie werken “De Adelaar” B.V., a major player in generic veterinary medicines. In May 2017, Interdos Pharma offered me the chance to change my perspective to human medicine, which is more in line with my background. I enjoy to continuously search for the balance between creating the best workable situation for companies while still providing the authorities with sufficient information to obtain and maintain registrations for the desired medicines. People describe me as curious, accurate, reliable and social and I tend to incorporate these properties in my work as much as possible. I really look forward to our close collaboration one day!
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.
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.
With a background in Pharmacy, I have over 14 years of experience in the Human Pharmaceutical Industry. During my career, I worked for generic and originator pharmaceutical companies mostly as Regulatory Coordinator who was in charge for domestic regulatory activities as well as for the regulatory activities abroad. For a while, besides regulatory activities I was in charge of Pharmacovigilance and Quality. One year I was in charge of conducting the NIS (non-interventional studies) as Local project manager, after which I returned to Regulatory Affairs. Recently I joined Interdos Regulatory Team as Regulatory Affairs Officer. I am responsible, reliable, dedicated, detail-oriented and a team player.
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.
Meryem Mutlu studied Chemical Engineering in Marmara University, Turkey and afterwards started working as a Regulatory Affairs Specialist for human medicines. For 3 years, she had worked for preparing and updating eCTD dossiers for Middle East and Asia countries. Since September 2019, she is working at Interdos as a Regulatory Affairs Officer. In this position, she prepares variation application and registration dossiers for EMEA region.
I am a Regulatory Affairs Officer, 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.
An enthusiastic and passionate Regulatory Affairs Officer with Biomedical background. Mainly experienced in obtaining and maintaining regulatory licenses for medicinal products in the BENELUX, introducing these products on the market and making sure that they are compliant with European and national legislations and guidelines.
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.
With a background in chemistry I worked for many years in the Quality and Regulatory Affairs department of a leading company for medicinal gases in the Netherlands (Linde Healthcare Benelux). Besides Regulatory Affairs activities for human medicines and medical devices I was responsible for handling of vigilance cases for medicines and medical devices reported from the market. Since February 2017 I took the opportunity to increase my knowledge about pharmacovigilance and joined Interdos as a pharmacovigilance officer where I am among others involved in writing of Risk Management Plans, signal detection reports and the realization of Pharmacovigilance SOP’s. People close to me would describe me as a stable, reliable and very down to earth person.
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 pharmacist with a Master’s degree in pharmacy and a specialization in Pharmacology. With the keen interest in the drug safety, I started my career in the Pharmacovigilance in Aug 2011 and continued developing my skills by experiencing different roles in an international setting of different companies. My previous exposure brings me value as Pharmacovigilance Consultant with on-the-ground experience in advising and supporting PV teams at different Pharma companies through managing pharmacovigilance and medical projects (clinical and post marketing), QPPV office activities (support of QPPV, compliance and communication with Authorities), writing and designing the QMS for different clients with deep technology knowledge while ensuring GVP compliance and business benefit. I am very happy to be a part of Interdos to contribute my experience and to learn from all the colleagues of Interdos to continue my journey in the field of Pharmacovigilance. At the moment, I am also involved in SDEAs, PSURs, signal detection and risk management plans for Interdos and its various clients.
With Masters focused in Pharmacy, I have started my career in pharmacovigilance more than two years ago. Within this period, I have gained experience in writing and updating Quality Documents, Pharmacovigilance System Master Files, Safety Data Exchange Agreements and monitoring compliance throughout the whole PV System. Moreover, I had also an opportunity to act as a PV Project Manager where I learned how to prepare project scope and objectives based on the signed agreement and to manage and provide the whole PV System services for a client with wide portfolio. I was the primary contact point for the project related matters, had an overview of all tasks needed to be delivered to the client and making sure the quality standards applicable to the client were met. In this period, I have gained a lot of theoretical skills and knowledge in pharmacovigilance, improved my communication as well as leadership skills. Joining the Interdos team as Pharmacovigilance Officer I am looking forward to expand my knowledge in pharmacovigilance and put my proven skills and commitment to ensure enhancement of patient care and patient safety in relation to the use of medicines.