FAQs
For an easier orientation, the FAQs are sorted by topic:
- Pharmacovigilance
- Pharmaceutical law / Compliance
- Medical devices
- BoosConsulting
- Dr. Monika Boos
- General questions and commissioning
Pharmacovigilance
What is pharmacovigilance?
Pharmacovigilance (drug safety) is science that covers all activities related to the detection, assessment, evaluation and prevention of adverse effects and other medicine-related issues.
Pharmacovigilance / drug safety (or the benefit-risk ratio of drugs, respectively) is a central element in pharmaceutical medicine. It plays a major role both during the clinical development of an active ingredient (clinical safety) and after the drug's approval (post-authorisation safety).
The aim of pharmacovigilance is to identify drug risks due to side effects or interactions as early as possible (or to minimise them as early as possible, respectively) in order to increase patient safety.
The term pharmacovigilance is derived from the Greek pharmakon (remedy, poison, charm) and the Latin vigilantia (vigilance, care).
Why is pharmacovigilance important?
Pharmacovigilance (or drug safety) involves the monitoring and medical evaluation of known and potential drug risks, such as side effects or interactions. Pharmacovigilance is a continuous process that monitors the safety of a drug and its benefit-risk balance throughout the product's entire life cycle. The aim of this proactive and systematic process is to identify and minimise such risks at an early stage, thus ensuring the greatest possible patient safety.
What does an EU QPPV do?
An EU QPPV (Qualified Person for Pharmacovigilance) must be appointed by a pharmaceutical company wishing to authorise and market medicinal products in the European Union (EU/EEA) and is responsible for its pharmacovigilance system. The EU QPPV ensures that the Marketing Authorisation Holder complies with its legal obligations to monitor and evaluate the safety of medicinal products and serves as the direct contact for Health Authorities.
The EU QPPV must have in-depth knowledge of pharmacovigilance, relevant laws and regulations, and a high level of professional qualification. The EU QPPV should be a medical doctor. If the EU QPPV is not a medical doctor, the Marketing Authorisation Holder needs to make sure that he or she has access to a medical doctor on a 24/7 basis.
What does a Graduated Plan Officer do?
The Graduated Plan Officer (GPO) is responsible for establishing and managing a pharmacovigilance system at the German level. The GPO is responsible for collecting and evaluating reports of drug risks and coordinating the necessary risk minimisation measures. The GPO must possess the necessary expertise and reliability for this purpose, bear personal liability for the pharmacovigilance system, and serve as the primary contact for the German Health Authorities.
The Graduated Plan Officer was named after an administrative guideline that provided two levels of measures to mitigate drug risks (i.e. gradually increasing measures).
What is a PSUR?
A Periodic Safety Update Report (PSUR) contains a summary, analysis, and evaluation of the benefit-risk balance of a medicinal product or active ingredient (Integrated Benefit-Risk Analysis). This type of retrospective, cumulative report must be submitted to the Health Authorities in a specific format (PBRER, Periodic Benefit-Risk Evaluation Report) and at specific intervals (e.g., every 6 months, every 5 years, depending on the medicinal product). It helps the Authorities decide whether, for example, restrictions on drug use need to be imposed or additional adverse effects need to be included in the package leaflet.
What is an RMP?
A Risk Management Plan (RMP) is a comprehensive document that describes the relevant risks of a medicinal product or active ingredient. It contains strategies and measures to identify, assess, or minimise the frequency and/or severity of these known and potential risks or potential knowledge gaps. For this purpose, specific measures for each risk are proactively defined. An RMP is intended to ensure that the benefits of a product outweigh its risks (or should significantly influence the benefit-risk balance) to ensure patient safety.
The format of an RMP is fixed, but the contents are continually updated or adapted as a dynamic document throughout the entire product life cycle and subsequently submitted to the Authorities as required.
What are risk minimising measures (RMMs) in pharmacovigilance?
Risk minimisation measures taken for a specific medicinal product / active substance are intended to prevent or reduce the occurrence of certain side effects or to reduce the severity of the side effects or the impact on the patient.
Risk minimisation measures (RMM) are divided into routine measures (routine RMM) and additional measures (additional RMM).
Routine measures include, for example, adapting the product information and package leaflet (for e.g. including new side effects, contraindications or warnings), reducing the package size or making the medicinal product subject to medical prescription.
If such measures are not sufficient, additional risk-minimisation measures may need to be taken, such as educational materials (for doctors, pharmacists, patients, relatives, carers, as applicable), special prescription/dispensing systems or regular laboratory tests.
What is a pharmacovigilance system?
A pharmacovigilance system is a structure for monitoring the safety of medicinal products after their approval and, where applicable, during commercialisation. It involves the systematic collection, assessment, evaluation and prevention of adverse reactions or other drug-related sissues. The aim is to ensure the safety, quality and efficacy of medicinal products, to detect changes in the benefit-risk balance at an early stage, and to minimise risks to patient health.
The elements of such a pharmacovigilance system and the processes required within a pharmaceutical company are regulatorily stipulated; the EU QPPV bears overall responsibility for their implementation and execution.
What is a PSMF?
A Pharmacovigilance System Master File (PSMF) contains a detailed description of a Marketing Authorisation Holder's pharmacovigilance system. It includes information on the structure, processes, and responsibilities within the pharmacovigilance system, including interfaces with other departments and external partners. The PSMF must be kept up to date and made available to Health Authorities upon request (within a specified timeframe, e.g., seven days). It serves as the primary document for quickly obtaining a complete overview of the company's pharmacovigilance system.
What does the Pharmacovigilance Risk Assessment Committee (PRAC) do?
The Pharmacovigilance Risk Assessment Committee (PRAC) is a body within the European Medicines Agency (EMA) whose primary task is to evaluate and monitor the safety of authorised human medicines. The PRAC assesses, for example, reports of adverse reactions received from pharmaceutical companies and authorities, develops and recommends risk minimisation measures (such as changes to product information or the conduct of safety studies), and monitors the effectiveness of risk minimisation measures.
What does pharmacovigilance mean in clinical trials (clinical safety)?
Pharmacovigilance in clinical trials (so-called clinical safety) refers to the systematic monitoring of the safety of investigational medicinal products during clinical trials in order to minimise the risk to study participants and to continuously optimise the benefit-risk assessment of an investigational medicinal product.
Clinical safety includes, for example, the documentation of all adverse events that occur in the study participant or patient, the assessment of whether these are serious (SAEs) and maybe causally related to the investigational drug, the reporting of SUSARs (Suspected Unexpected Serious Adverse Reactions) to Authorities and Ethics Committees, and the preparation of safety reports on the study (Development Safety Update Reports, DSURs).
What is the difference between GCP and GVP?
Both, Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP), are essential components of the regulatory framework for medicinal products, and both contain requirements for drug safety.
The GCP Guideline, an international standard for the ethical and scientifically correct conduct of clinical trials with human subjects or patients, covers the planning, conduct, documentation, and reporting of clinical trials, including the recording and reporting of adverse events (“side effects”) that occur during the study.
The GVP modules of the European Medicines Agency (EMA) contain requirements for monitoring the safety of medicinal products after marketing authorisation. This includes, among other things, the collection, assessment, reporting and evaluation of adverse drug reactions with the aim of identifying and minimising potential risks of medicinal products.
Hence, GCP is mainly) applicable before the approval of a medicinal product, while GVP is applicable after the approval of the medicinal product.
Pharmaceutical law / Compliance
What is pharmaceutical law?
Pharmaceutical law is an interdisciplinary field of law that encompasses the law governing pharmaceuticals, medical devices, and medical aids. Pharmaceutical law also encompasses aspects of e.g. medicinal products advertising law, data protection law, patent law, competition law, and criminal law.
In the area of pharmaceuticals, for example, it governs the manufacture, approval, monitoring, and distribution or dispensing. In the area of medical devices, it governs the safety, quality, and performance of medical devices, as well as their market access requirements and monitoring/vigilance.
What is the difference between a medicinal product and a medical device?
The main difference between a medicinal product and a medical device lies in their mode of action. Medicinal products act primarily through pharmacological, immunological, or metabolic mechanisms, while medical devices achieve their effects primarily through mechanical, physical, or physicochemical mechanisms.
This distinction is important in order to be able to bring the product onto the market, since medicinal products and medical devices are subject to different legal frameworks.
Medicines are subject to an official authority approval procedure and must demonstrate their quality, effectiveness and safety in clinical trials.
Medical devices undergo a conformity assessment procedure to obtain a CE marking, which confirms that the product complies with legal requirements.
What regulations apply to the advertising of medicinal products?
In Germany, the advertising for medicinal product and medical devices is subject to the German Medicinal Products Advertising Act (HWG).
The HWG is intended to protect patients and therefore prohibits, for example, misleading information, advertising for unapproved medicinal products or advertising for prescription-only medicinal products outside of healthcare professionals.
The law on advertising of medicinal products also contains specific requirements that must be implemented when advertising medicinal products; they depend on whether the medicinal product advertising is addressed to doctors/pharmacists (i.e. healthcare professionals) or at patients (non- healthcare professional) and which advertising medium (specialist journal, magazine, television, internet, etc.) is used.
The HWG is closely linked to the Act against Unfair Competition (UWG), which protects consumers in general, i.e. not just in the healthcare sector, from unfair business practices. A violation of the HWG may therefore also constitute a violation of the UWG (and thus potentially lead to warning letters or injunctions).
What mandatory information is required when advertising medicinal products?
Depending on the target group (healthcare professionals versus medical laypersons) and the advertising medium, certain requirements must be met.
In print media for healthcare professionals (e.g. medical journals), advertising for medicinal products must contain certain mandatory information, such as the pharmaceutical company, composition of the medicinal product, indications, contraindications, side effects and, where applicable, warnings.
For advertising outside of the healthcare professionals’ area (e.g. on television), the text "For risks and side effects, read the package leaflet and ask your doctor or pharmacist" must be included.
In the case of purely reminder advertising, information of this kind may be omitted.
It should also be noted that prescription drugs may only be advertised to healthcare professionals, while only non-prescription drugs may be advertised to medical laypersons (such as patients).
What is the role of an Information Officer?
The Information Officer is responsible for scientific information on medicinal products. The Information Officer verifies whether scientific information about a medicinal product, such as labelling, product information, package inserts, and advertising materials, complies with the Marketing authorisation documents. The Information Officer ensures that all information and advertising measures comply with the provisions of the Medicinal Products Advertising Act (HWG) and the Act against Unfair Competition (UWG) and approves them.
The Information Officer must meet certain requirements in terms of expertise and reliability in order to be appointed by the Marketing Authorisation Holder and notified to the authority.
What penalties are there for violations of pharmaceutical law?
The individual areas of pharmaceutical law, for example through the German Medicines Act (AMG), the Medicinal Products Advertising Act (HWG), the Product Liability Act (ProdHaftG) and other standards, each provide for its own sanctions for dealing with violations.
Violations of the German Medicines Act (such as placing medicines on the market without the required package insert, failing to submit a side effect report, submitting it incorrectly, or not submitting it in a timely manner to the authorities) can be punished as administrative offenses with fines of up to 25,000 Euro each. Placing a counterfeit medicine or counterfeit active ingredients on the market, for example, is punishable by up to three years' imprisonment.
Under the German Medicinal Products Advertising Act (HWG), a fine of up to 50,000 Euro can be imposed for an administrative offense (such as missing mandatory information in advertising materials, advertising a prescription drug outside of professional circles). Anyone found guilty of misleading advertising may even face an imprisonment of up to one year.
The German Medical Devices Law Implementation Act (MPDG) stipulates that an administrative offence (such as placing a medical device on the market without a CE mark or without German-language information for users and patients or as a manufacturer not having a person with the necessary expertise in the field of medical device law can be punished with a fine of up to 30,000 Euro. Anyone who manufactures or markets a counterfeit product, part, or component is punishable by up to three years' imprisonment.
There are also various sanctioning options in the healthcare/life sciences sector at European level, e.g. through the General Data Protection Regulation (GDPR) or the AI Regulation (AI Act).
What is the European AI Regulation (EU AI Act)?
The European AI Regulation (AI Act) creates a uniform framework for the development, deployment, and use of artificial intelligence (AI). It aims to ensure a high level of protection for people's fundamental rights, safety, and health while promoting innovation in the field of AI.
Building trust in the development and use of AI through transparent and ethical practices is of great importance.
A central element of the AI Regulation is the risk-based approach. AI systems are classified into different categories based on their potential risk to users, each of which is subject to specific obligations.
AI systems that pose an unacceptable risk and are therefore prohibited (such as behavioural manipulation or emotion recognition systems) are classified as prohibited practices in the AI field.
For high-risk AI systems, e.g. in healthcare or personnel selection, strict requirements apply with regard to risk management systems, data governance, technical documentation, record-keeping, transparency, human oversight and cybersecurity.
For low-risk AI systems that use generative AI in the form of chatbots or to create audio, image, video or text content, there are labelling and transparency requirements to inform users and minimise risks.
What do I need to consider if I want to integrate AI into my company?
Anyone who wants to integrate AI systems into their company or processes should first check whether some basic requirements are already in place or can at least be created.
In the case of purely paper-based processes, it may be advisable to first digitize the processes (with possible restructuring) before considering automation (with or without artificial intelligence).
The implementation of AI systems should then be in compliance with the EU AI Regulation (AI Act). If the AI to be deployed is considered a high-risk AI system (e.g., because it handles special categories of personal data (such as health data)), the appropriate measures specified for this risk class (such as risk management systems, data governance, technical documentation, record-keeping requirements, transparency, human oversight, and cybersecurity) must be implemented.
If the AI system to be implemented is relatively low-risk (such as a chatbot or generative AI for creating audio, image, video or text content), the labelling and transparency requirements specified in the AI Act must be complied with in order to inform users and minimise risks.
Depending on the AI system, the interfaces to other legal regulations, such as data protection law, intellectual property law, medical device law or the Works Constitution Act (works council), must also be taken into account.
For individual advice and support, please contact us directly.
What does compliance mean?
Compliance means adhering to the relevant laws and regulations that apply to the manufacture, development, testing, marketing and monitoring of medicinal products and medical devices.
These include, for example, the regulatory requirements of the European Medicines Agency (EMA), the German Medicines Act (AMG), Medical Devices Implementation Act (MPDG) or Medicinal Products Advertising Act (HWG), the regulations of the US Food and Drug Administration (FDA), as well as European or international "good practices" (e.g. GMP, GLP, GCP, GDP or GVP).
A good compliance system ensures, for example, that products are safe and effective, that processes meet the highest possible quality standards, that risks (e.g. in relation to patient safety) are minimised and that possible legal consequences for pharmaceutical companies or medical device manufacturers are avoided.
What does AI compliance mean?
AI compliance means adhering to the relevant laws, regulations and ethical standards that apply to the use of artificial intelligence, for example in the areas of healthcare, life sciences, pharmaceuticals, biotech or medical devices.
These include, for example, the European AI Regulation (AI Act), the WHO Guidance on Ethics and Governance of Artificial Intelligence for Health, the Reflection Paper on the Use of Artificial Intelligence (AI) in the Medicinal Product Lifecycle of the European Medicines Agency (EMA) or the AI Principles of the OECD.
A good compliance system or quality management system ensures, for example, that AI is developed in compliance with fundamental rights, that AI is trustworthy and can be used safely, that risks related to health, safety or fundamental rights (e.g. data protection, privacy, fairness, patient safety) are minimised and possible legal consequences for the companies concerned are avoided.
What does data protection and privacy mean and what regulations apply?
Data privacy is about protecting personal data from unauthorised collection, processing, disclosure and other misuse in order to protect the privacy of the data subject.
Data protection ensures that the data itself is not damaged, altered or deleted (which, for example, is the basis for drug approval or, in pharmacovigilance, for the decision to include new side effects or interactions in the package leaflet).
The requirements for data protection and data privacy are covered, for example, by the European General Data Protection Regulation (GDPR) or the German Federal Data Protection Act (BDSG).
What are the principles of the GDPR?
The General Data Protection Regulation (GDPR) governs the processing of personal data. The principles of the GDPR include lawfulness, transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity, and confidentiality. The data controller must adhere to these principles, document them, and provide evidence to the data protection authorities if required.
What are personal data?
Personal data is any information relating to an identified or identifiable natural person, either directly (e.g. name, address, date of birth) or indirectly (e.g. via IP address, customer number, location data).
Special categories of personal data include, for example, health data, genetic data or biometric data; these are considered to be particularly worthy of protection and the protective measures taken are therefore higher.
Special categories of personal data are processed, for example, in pharmacovigilance when patients, doctors or pharmacists report possible adverse reactions to pharmaceutical companies or Health Authorities. The pharmacovigilance department must therefore adhere to particularly strict data protection and privacy measures.
What is a Data Protection Impact Assessment (DPIA)?
A Data Protection Impact Assessment (DPIA) is used to identify and minimise risks associated with the processing of personal data. Its goal is to ensure that data processing is GDPR-compliant, i.e., compliance with the General Data Protection Regulation is achieved.
The DPIA describes the purpose and necessity/proportionality of the data processing, the possible risks for the data subjects and the planned technical and organisational measures to minimise these risks.
A DPIA must always be conducted when a planned data processing operation is likely to result in a high risk to the rights and freedoms of natural persons. This is particularly the case when special categories of personal data are processed (e.g., in pharmacovigilance).
What are the consequences of a data breach?
In addition to reputational damage, loss of trust, loss of revenue and possible costs for remediation and notification of those affected, data protection breaches also mean legal consequences for companies through lawsuits from those affected or fines imposed by the authorities.
What is a Data Protection Officer?
A Data Protection Officer (DPO) is responsible for monitoring compliance with data protection regulations within a company or organisation and ensuring that personal data is treated securely and confidentially. They advise and support those responsible in implementing statutory data protection regulations, raise employee awareness of data protection issues, conduct data protection training, participate in the preparation of data protection impact assessments, and serve as the contact person for data protection supervisory authorities.
A Data Protection Officer requires a combination of expertise in data protection law and data protection practice to fulfil these tasks and be appointed as such. However, no particular training or certification is officially required.
Medical devices
What are medical devices?
Medical devices are products intended for medical use in humans for the diagnosis, treatment, monitoring or prevention of diseases. They differ from medicinal products by achieving their main effect not primarily through pharmacological, metabolic or immunological processes, but rather through physical, physicochemical or mechanical mechanisms.
Medical devices include, for example, plasters, compresses, bandages, hearing aids, glasses, blood glucose meters, artificial hip joints, heart valves, pacemakers, wheelchairs, prostheses, X-ray machines, ultrasound machines and other medical technology, medical software (e.g. for analysing X-ray images), substance-based medical devices (e.g. saline nasal sprays) and in-vitro diagnostics (IVD).
Which products do not fall under the definition of medical devices?
Whether a product is a medical device depends primarily on the manufacturer’s intended purpose.
However, medicinal products, cosmetics, foodstuffs, food supplements or supplementary balanced diets, each with its own legal framework, must be distinguished from medical devices.
The fact that the distinction between, for example, medical devices and medicinal products is not entirely trivial is demonstrated by numerous court decisions which, based on the intended purpose as such or the presentation or advertising of the product, have ultimately classified the (alleged) medical device as a medicinal product.
How are medical devices classified?
In the EU, medical devices are divided into four classes according to the European Medical Device Regulation (MDR): I, IIa, IIb, and III. This classification is based on a risk-based system that considers the potential hazard to the patient and incorporates factors such as duration of use, site of application (invasive or non-invasive), degree of invasiveness, use of biological material, and reusability.
Class I (low risk) includes products such as bandages or simple aids.
Class IIa (medium risk) includes hearing aids and ultrasound devices, for example.
Class IIb (medium/high risk) includes, for example, reusable surgical instruments or certain in vitro diagnostic devices.
Class III (high risk) includes pacemakers or implants, for example.
What requirements must medical devices meet to be placed on the EU market?
To be placed on the EU market, medical devices must meet a number of requirements set out in the Medical Device Regulation (MDR). These include compliance with general safety and performance requirements, clinical evaluation requirements (to demonstrate the safety and performance of the device), a risk management system (to identify, assess, and minimise potential risks), a quality management system, and the preparation of technical documentation (containing relevant information about the device, its manufacture, and its use).
Based on this, the product undergoes a conformity assessment procedure by a notified body and subsequently receives a CE marking, which certifies that the medical device complies with the requirements of the MDR and may be placed on the market.
Only for Class I medical devices the conformity assessment is carried out by the manufacturer himself.
What is the CE marking and what does it mean?
The CE marking on medical devices confirms that the product complies with the essential safety and performance requirements of the European Medical Device Regulation (MDR) and any relevant DIN/ISO standards. It is a mandatory mark for medical devices intended to be placed on the EU market and enables the free movement of goods within the European Economic Area (EEA).
How are medical devices monitored on the market?
Post-market surveillance is a continuous and systematic process that ensures additional safety after a medical device has been launched on the market. The goal of post-market surveillance is to identify risks associated with the product during practical use, detect safety issues or product defects, and initiate any corrective or preventive measures as part of a continuous benefit-risk assessment.
During the post-market clinical follow-up, the manufacturer collects clinical data resulting from the use of the product to confirm safety and performance during the expected lifetime of the product and to identify emerging risks.
The manufacturer reports incidents and field safety corrective actions to the relevant authorities via its vigilance system.
The overall system of proactive post-market surveillance by the manufacturer (monitoring after the product has been placed on the market) and market surveillance by the authorities thus makes a decisive contribution to user and patient safety.
What is medical device vigilance?
The term vigilance is derived from the Latin vigilantia (watchfulness, care) and deals with the risks of medical devices placed on the market as well as measures taken to ensure the safety of patients and users.
Manufacturers of medical devices must operate a vigilance system through which they can collect and evaluate incidents related to their products in order to be able to report serious incidents, such as a malfunction or deterioration of the properties or performance of the product, or an undesirable side effect, to the Health Authorities in a timely manner.
Taking a Field Safety Corrective Action (FSA), i.e. a corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident related to its product, is also part of this reactive vigilance reporting system.
The vigilance system, as part of the manufacturer’s post-market surveillance, serves to ensure user and patient safety.
What should be considered when advertising medical devices?
In Germany, advertising for medical devices is subject to the German Medicines Advertising Act (HWG) and the Unfair Competition Act (UWG).
Prohibited are, for example, false statements about the product, its properties and its effectiveness, false performance promises and misleading advertising.
It is also important to consider whether the advertising is aimed at medical professionals or laypersons, as advertising to laypersons for certain medical products is prohibited.
BoosConsulting
What services does BoosConsulting provide?
From consulting or interim management, through sparring partner offers to outsourcing - as an owner-led enterprise, BoosConsulting offers tailor-made solutions in the life sciences sectors of pharmaceuticals, biotechnology, medicine and healthcare.
The support ranges from temporary bridging of sudden resource constraints up to long-term services for products, projects and customers.
BoosConsulting specialises in the following areas:
Which clients does BoosConsulting work for?
BoosConsulting offers tailor-made solutions in the life sciences sectors of pharma, biotechnology, medicine, and healthcare, supporting pharmaceutical companies, biotech enterprises, start-ups, and medical device manufacturers that temporarily require qualified personnel or specific expertise (e.g. for implementing regulatory requirements). So that compliance is ensured, regulatory deadlines are met, and the workload of the clients gets noticeably reduced.
BoosConsulting specialises in pharmacovigilance, pharmaceutical law / compliance and medical devices.
What is interim management?
Interim management refers to the temporary assumption of management or specialist positions by external experts. These temporary managers support companies in addressing specific challenges, managing change or bridging acute resource constraints.
Interim managers' assignments are temporary, and they typically do not pursue career goals of their own with the client (i.e., they leave the company immediately after completing the assignment). Since interim managers are usually entrepreneurs themselves, they have an efficient working style.
Interim managers are characterised by their high level of professional expertise, extensive work experience, and rapid integration. Companies also benefit from the flexible availability, rapid deployment and targeted to the point expertise of interim managers.
In pharmacovigilance, particular areas where interim managers frequently come into action include the positions of EU QPPV, Graduated Plan Officer, or Head of Drug Safety (at local or global level).
Another example for a particular function within healthcare is the Information Officer who can also be covered by an interim manager.
In which phases of product development and marketing does BoosConsulting offer services?
BoosConsulting's range of services covers both, the area of clinical trials / clinical studies and the area following the approval of a product within the European Union or the European Economic Area.
In the area of drug safety, this means that BoosConsulting has in-depth knowledge and practical experience in both the GCP and GVP area, thus covering clinical safety and post-marketing pharmacovigilance.
What can I outsource to BoosConsulting?
In pharmacovigilance, a variety of tasks can be outsourced to external service providers, business partners or contractors. Outsourcing to BoosConsulting is possible, for example, in the following areas:
- Assuming the functions of the EU QPPV or the Graduated Plan Officer
- Preparing cumulative reports (such as PSUR, RMP or DSUR) or other pharmacovigilance-relevant documents
- Preparing, conducting and following up on pharmacovigilance audits
- Preparing and following up on pharmacovigilance inspections
- Establishing, organising and/or operating a pharmacovigilance system at the local level
- Providing expertise for other local or global pharmacovigilance tasks
Your benefit:
- Save costs on personnel and infrastructure
- Adapt your PV activities flexibly to your needs
- Have specialist knowledge and many years of experience at your disposal
- Improve your compliance with regulatory requirements
- Focus on your core responsibilities.
What do I need to do to receive support?
Working with BoosConsulting takes place in 3 simple steps:
- Contact us by email or phone and describe your request
- Clarify any details (via e-mail or initial consultation) and place an order
- Get help directly - without time-consuming bureaucratic hurdles, commissions / agency fees, or other overhead costs
I need a larger team or specialists from different disciplines. Can you help here?
Dr. Monika Boos
What services does Dr. Monika Boos offer?
Dr. Monika Boos supports pharmaceutical and biotech companies that require qualified personnel or specific expertise (e.g., for implementing regulatory requirements), particularly in the area of pharmacovigilance (drug safety and patient safety). So that compliance is ensured, regulatory deadlines are adhered to, and the client’s workload gets noticeably reduced.
Further core areas outside of pharmacovigilance include services related to medical devices as well as specific matters in the field of pharmaceutical law.
Dr. Monika Boos works as an interim manager, consultant and sparring partner, as operational support or outsourcing solution for established companies or start-ups.
What qualifications does Dr. Monika Boos have?
Dr. Monika Boos is a licensed medical doctor, holds a doctorate in clinical pharmacology, completed training as a pharmaceutical technical assistant (PTA), obtained a master's degree in pharmaceutical law and is a TUEV-certified AI compliance officer.
This multidisciplinary training in healthcare/life sciences, combined with work experience in pharmacies, hospitals, medical practice, the pharmaceutical industry, and self-employment, enables her to approach her clients' challenges from a variety of perspectives, thus providing tailored and targeted support. This also applies to the interfaces between medical, pharmaceutical, and legal issues.
Further details about Dr. Monika Boos and what characterises her can be found under her profile.
Her strengths include high-quality qualifications, comprehensive specialist knowledge, extensive professional experience, analytical thinking, structured work, accuracy, and reliability. This is also reflected in the references she receives from her clients.
What professional experience does Dr. Monika Boos have?
After working in pharmacies, hospitals and a doctor's offices, Dr. Monika Boos worked for ten years in various research-based pharmaceutical companies, gaining German, European and international experience and gradually assuming more personnel responsibility, before founding her own company in 2014, with which she has since supported pharmaceutical companies, biotech companies and medical device manufacturers on issues relating to pharmacovigilance, pharmaceutical law and compliance.
What is pharmaceutical medicine?
Pharmaceutical medicine is a medical-scientific discipline concerned with the discovery, research, development, approval, quality assurance, efficacy, and safety of pharmaceuticals. It encompasses both clinical research and the commercial application of pharmaceuticals and thus contributes significantly to the health and safety of patients.
Hence, pharmaceutical physicians use their expertise (e.g. in pharmacovigilance) to ensure that medicines are effective for patients and do not harm.
What is a Master of Laws (LL.M.)?
A Master of Laws (LL.M.) is an academic degree in the field of law. The abbreviation LL.M. for Master of Laws is derived from the Latin legum magister ("master of laws/rights" from lex for law).
Since the Bologna Process for the creation of a uniform European Higher Education Area with Bachelor's and Master's degrees has not yet been fully implemented in Germany, the Bachelor's or Master's of Laws currently represents an alternative legal degree alongside the classic state examination.
In contrast to other European countries, however, the Master of Laws in Germany does not entitle the holder to practice the classic legal professions such as judge, lawyer, public prosecutor or notary, which a fully qualified lawyer (who has successfully passed both state law examinations) can pursue.
The academic degree nevertheless qualifies the Master of Laws holder for a wide range of legal activities, particularly in an international context. They can, for example, take on positions in the legal departments of large corporations, international law firms, the public sector, associations, or management consultancies, or assume roles in compliance, contract law, or data protection.
The fields of practice are thus similar to those of graduate lawyers (Dipl.-Jur.), who, after completing a traditional law degree, passed the first state examination but failed the second. However, unlike graduate lawyers (who often work as in-house lawyers, e.g., in the legal departments of pharmaceutical companies), Master of Laws holders usually directly acquire specialized knowledge tailored to their respective field of practice (e.g., pharmaceutical law) rather than simply having a general legal education.
How can I contract Dr. Monika Boos for a service?
Book Dr. Monika Boos in 3 easy steps:
- You contact us by e-mail or telephone and describe your request.
- We clarify any questions or details for the order placement.
- You receive direct help - without time-consuming bureaucratic hurdles, commissions / agency fees, or other overhead costs.
If you require a larger team or specialists from different disciplines, please feel free to contact us and benefit from an extensive network of additional experts who can be called upon as needed.
General questions and contracting for services
How can I contact Dr. Monika Boos / BoosConsulting?
Please contact us by e-mail at Contact@BoosConsulting.de or by phone at +49 6150 1875400. You can also find the contact details here.
Is the initial consultation free of charge?
Yes, of course, the first consultation is free of charge. Simply call or send an e-mail. You can find the contact details here.
What should I do if I don't yet know exactly what kind of support I need?
Simply contact us by e-mail or phone (see contact) and describe your concern or the challenge you're currently facing. Even if you don't yet have a clear idea of whether you need a consultant, an interim manager, a sparring partner, operational support, or an outsourcing solution to relieve your workload, a personal conversation can usually quickly lead to the right solution.
What should I do if I don't yet know exactly how long I will need support?
BoosConsulting is happy to assist you with anything from short-term assignments (e.g. in the event of sudden resource constraints) to long-term services for products, projects and customers - simply contact us here and let's talk.
I need support, but only part-time. Is that possible?
From hourly/daily support to full-time availability - you decide how much support you need. Get in touch and let's find the best possible solution together.
I have questions that I can't find answers to here. What can I do?
Simply contact us at +49 6150 1875400 or Contact@BoosConsulting.de - these questions can usually be easily clarified in a personal exchange.