This issue’s contribution comes from Dr. Paolo Biffignandi’s colleague Dr. Parvinder Punia, a Senior Regulatory Affairs Manager at pan-European regulatory affairs organisation ELC Group. With a scientific background, Dr. Punia has nine years of regulatory experience, which includes three years from within two EU health agencies (the National Authority of Medicines and Health Products (INFARMED, I.P.) in Portugal and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK). She has represented the UK agency at the European Medicines Agency (EMEA) level. Her key expertise is in strategy, budgeting, preparation, co-ordination and review of a variety of scientific and regulatory documents for European and experience in non-European countries. Dr. Punia has extensive knowledge of the development cycle and internal knowledge of the EU and other regulated region procedures and has worked in a business development capacity.
Regulatory affairs is a comparatively new profession that developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. The regulatory professional should have a mix of scientific knowledge, negotiation skills and business intelligence, which is a science in itself and can be applied to the industry, the academy and the authorities.
But how much of it is really science, and how much of it is affairs? The answer could be simple, as suggested by the EMA: ‘Regulatory science is defined as a range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied medicinal science and social sciences, and contributes to the development of regulatory standards and tools’. So, a scientific discipline, but one conducted within a legal framework.
Since the entire development pipeline must be within regulatory boundaries, where one’s particular professional skills are being applied can also influence how one views the profession. A formulation developer solely concerned with reverse technology of a reference product may only be applying scientific knowledge. The same would be applicable for a principal investigator of a clinical trial. However, in the background, there are the monitors of compliance, who ensure that the standards required are adhered to. These are the negotiators of the regulation. At the opposite end of the spectrum are the professionals solely concerned with management of submissions to agencies. The majority of the work is administrative and project management-based, with minimum of science involved. These industry professionals would be engaged in persuading regulators to review material from not only a scientific perspective, but possibly also from a patient and commercial perspective.
The basis of pharmaceutical developments is always attributed to science. However, with the reduction of novel drug research and the expansion of innovation based on old discoveries, it is difficult to avoid the ‘affairs’ side of the profession. Nowadays, regulators are constantly required to answer deep questions as to why such guidelines or requirements exist. Although steeped in scientific history, many of the guidelines are open for discussion in regard to any single development. This is the crossover line between science and negotiation. However, the individuals engaged in such discussions must understand the technicalities of development sciences. This is not a general discipline, so such professionals may need to be qualified in one of the following: chemistry, pharmacology, toxicology, genetics, clinical trial expertise and biostatistics, amongst many other disciplines. Additionally, such discussions would require experts familiar with legislation, negotiation, budgeting, risk management and general compliance issues.
In essence, even the most skilled regulatory scientist must work in a team of professionals with different backgrounds and knowledge to ensure a positive outcome and a scientific approach to regulatory intelligence. This, ultimately, is the key for success.
Dr. Parvinder Punia, firstname.lastname@example.org.