6. September 2023 By Stefanie Ehrlich
Life sciences – a highly regulated project environment
A project manager does not need to have specialist knowledge to manage a project successfully!
That is a direct quote from a lecturer teaching on my project management course. After all – according to the lecturer – they have a team of professionals working with them who all have the expertise that the project needs. So that means that the task of the project manager (PM) is purely an organisational one and has much more to do with common sense, organisational skills and a sense of time.
The student version of me back then simply took this statement as a given. But now, eight years later and with a wealth of project management experience from a wide range of different projects under my belt, it is safe to say that I do not agree with this statement – not one bit. Sure, a non-specialist PM can manage a project purely in terms of organisation. But in my experience, it has always been the case that both customers and team members benefit from the advice that someone knowledgeable in that role can provide. By and large, people not only want PMs to be subject matter experts, but they also expect them to be.
This brings us to the question: why are the things project management experts have said so different to my own experiences? I guess because I work in life sciences and health and having a qualification in this sector is the foundation of any consultancy and project management career. Or at least it is in my experience. I will use the rest of this blog post to highlight why this is the case.
The diversity of the life sciences
When you take a closer look at the life sciences sector, it quickly becomes clear as to why the subject matter expertise of a PM not only have a positive impact on the success of a project, but can also be critical to it. But what are life sciences?
The term life sciences covers a wide range of scientific disciplines that deal with the structures and processes of living organisms. These include, for example, biology, molecular biology, medicine, biomedicine, medical technology, biotechnology, biochemistry, pharmacy, biophysics, bioinformatics, human biology, nutritional sciences, food research and veterinary medicine.
This list of different disciplines is an impressive illustration of how diverse the project environment can be in life sciences. As these projects have a direct and indirect impact on the lives of animals, plants and people, there is a wide range of standards, regulations, laws, ordinances and norms that need to be adhered to, which have a significant and considerable influence on the projects and thus also on project management. The aim of these regulations is to minimise or, in the best case, avoid hazards and risks to living beings, with humans being the first and foremost priority, of course.
It is the PM’s task to establish and ensure that the scope and objectives or a project are compatible with the specifications set out in the various regulations. This also includes managing all the efforts needed for documentation, validation and quality assurance that come up, which are centrally described in these regulations.
The life sciences are highly regulated
Next, I want to give you an overview of the various norms, regulations, laws, ordinances and standards and the influence they have on project management. This is of course by no means an exhaustive list – it is simply an overview of the regulations relevant to project management in the life sciences.
Good working practice
If you work in the life sciences environment, sooner or later you will stumble across the Good x Practice (GxP) guidelines. GxP includes the requirements for ‘good working practice’ guidelines for the laboratory (GLP), clinical trials (GCP), clinical laboratory (GCLP), pharmacovigilance (GVP), manufacturing (GMP), automated manufacturing using IT systems (GAMP), agriculture (GAP), distribution (GDP) and others. They were established to ensure the safety, efficacy and usability of medical devices, medicines, food and other life science products. They require not only employees and premises to undergo regular inspections, but procedures and processes (including IT systems) to be regularly reviewed too, so that product quality can be guaranteed.
Regulations for medical devices and in vitro diagnostic medical devices
The European Medical Device Regulation (MDR) and the European In Vitro Diagnostic Device Regulation (IVDR) are an amalgamation of several extremely relevant standards. These regulations set out the requirements which manufacturers of medical devices and in vitro diagnostics must meet in order to obtain market authorisation. The regulations mandate specifications and provisions on the following topics:
- Quality management
- Risk management
- Software life cycle processes
- Document management
- Medical informatics
- IT security for medical devices
Biocompatibility of medical devices
Another relevant standard is the biological assessment of medical devices according to EN ISO 10993, which applies in particular to devices worn close to the body. This standard is not only relevant for manufacturers of medical devices, but also for testing laboratories that test and assess these products for compatibility of the material used with the body. Limit values and complying with them also become relevant here. PMs must keep an eye on compliance, planning and testing of all 20 sub-standards, which must meet high scientific standards.
Validation and computer system validation
Given the importance of life sciences projects and their products, the concept of validation is also coming more into focus. While product verification and validation is already frequently included as a relevant planning point by PMs and manufacturers, software validation is not. But this in particular is becoming more and more relevant as the level of digitalisation in laboratories, clinics, pharmacies and pharmaceutical and biotechnology companies increases. Although there are no defined requirements for computer system validation (CSV), there are important documents that should be considered in the process. You can find out exactly what these are in Juan Carlos Peñafiel Suárez and Dr Vanessa Stahl’s blog post on ‘Why validating computer systems is important and the advantages that come along with it’.
Protecting patient data
One of the most frequent questions asked is about collecting health data from patients. This should be answered sufficiently at the start of the project, as Germany takes protecting personal data very seriously. There are several regulatory provisions in place for this:
- The General Data Protection Regulation (GDPR), which generally regulates data protection.
- The Patient Data Protection Act (PDSG), which was only passed in 2020 to ensure the security of patient data with a view to introducing the electronic patient record. If you are interested in this topic, you should take a look at the blog post my colleague Sabine Fischer wrote on the electronic patient record.
- Technical Guideline TR-03161, which is intended to serve as a guide to assist in the development of safe solutions.
These regulations stipulate that patient data may only be collected, stored, used and processed under very strict conditions. If the project and the product involve patient data, then this creates more work in the project, which the PM has to manage accordingly. The following aspects must be taken into account:
- A minimalistic approach to data collection
- Data security
- Storage and access to the data
- The degree of anonymisation and traceability
- Fulfilment of the right to self-disclosure
- Data management with regard to deletion, taking into account compliance with the obligation to provide evidence
The German Act on Advertising of Medical Products (Heilmittelwerbegesetz, HWG)
If the project involves marketing and selling medicines and medical devices (because they are the product), then the PM will have to deal with the German Act on Advertising of Medical Products (Heilmittelwerbegesetz, HWG). This regulates how these products must be advertised. Seeing as the PM is often the one responsible for reviewing the advertising materials, they should be familiar with the requirements the act sets out. The main points of the law are:
- The ban on misleading advertising
- The statements and information that adverts must contain
- Permissible and impermissible advertising
- The ban on teleshopping and advertising remote treatment
- The restriction of the advertising of prescription-only medicines to specialist groups
- The ban of accepting gratuities or promotional gifts from manufacturers (compliance)
Although I have only given you an overview of the various regulations you come across in the life sciences sector in this blog post, the list already seems very extensive. It inevitably begs the questions as to whether just one person can actually do all of this by themselves. Of course, each PM specialises in some of these areas thanks to their experience in them. But that aside, life scientists also have a particular ability to familiarise themselves with complex issues quickly and really understand them. By the same hand, a life sciences PM benefits from their specialisation and training when they are familiarising themselves with the complex regulations and the wide range of different topics in the life sciences sector.
The demands on life sciences projects and their team members are particularly high, as you can see from this blog post. Going back at the quote at the beginning of the blog post, you can see that good project management in the life sciences sector depends to a large extent on the PM offering a specialist background and continuously improving their qualifications through further training and certification.
As far as I am concerned, this is the only way a PM can ensure that they manage projects well and provide comprehensive advice to the decision-makers and meet the high demands and diverse regulations of the life sciences.
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