The programme is for individuals who are about to start a career in regulatory affairs or who want to continue their training in this special field. The principles of drug development and regulatory affairs applicable to biopharmaceuticals are basically the same as those for common medicinal products. However, various specific requirements are adapted to biopharmaceuticals due to their particular nature. The understanding of these distinct requirements is essential for successful development and authorisation of biopharmaceuticals.
The seminar programme provides this know-how and thus meets current needs of companies developing new biopharmaceuticals and agencies in charge of their authorisation. Both are in need to recruit specifically trained staff due to the increasing role of biopharmaceutical medicinal products.
The group of students is kept small to maximally 30 attendees allowing intensive and interactive learning.
Most of the regulatory affairs professionals have a degree in either pharmacy or medicine or another relevant life science or health subject.
It is always possible in the professional life to start a career in regulatory affairs and it can be based on varying background. Professionals may thus have different background such as from working in a pharmacy, in medical practice, in a research group or in a laboratory of any type. For biopharmaceutical-related regulatory affairs, it is advantageous and desirable to have some understanding of the complex nature of proteins and particular features of advanced therapies.
We welcome students from every part of the word: so far we had students from Austria, Belgium, Bolivia, Bulgaria, Egypt, Finland, France, Germany, Guatemala, Hungary, India, Ireland, Italy, Malta, Poland, Russia, Singapore, Spain, Sweden, Switzerland, Tanzania, The Netherlands, Turkey, Uk and the USA.
Career in Regulatory Affairs
Regulatory affairs is an important, exciting and challenging profession offering a wide range of job roles and responsibilities. This postgraduate Master Programme provides specialist knowledge and skills for biopharmaceutical-related regulatory affairs. It allows professionals to pursue a career in pharmaceutical companies and health authorities involved in the development and authorisation of medicinal products, respectively.
The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it performs at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.
Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively participating at every stage of development of new medicine and for post-marketing activities of authorised medicinal products.
Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all time post-marketing. The pharmaceutical industry deals with an increasing number of interesting drug candidates and all of them require involvement of the Regulatory Affairs department. Regulatory affairs professionals can play a key role in guiding drug development strategy in an increasingly global environment. But they also play an important operational role for example by giving consideration to best processes to follow and on structured interaction with regulatory authorities. Regulatory affairs is driven by good science and accordingly nothing remains static. Constantly changing subjects are essential features that make Regulatory Affairs a discipline important for companies and also interesting and challenging for individuals aiming at a career in this field.
Regulatory authorities and learned societies also require professionals well-educated in regulatory affairs. Regulatory authorities give advice on development strategies during the development phase, they authorise the start of clinical trial in man, and ultimately grant authorisations to market the product after rigorous scientific assessment of the respective applications. They also ensure safety is maintained by post-marketing safety surveillance and they conduct inspections of product manufacturing sites. For the conduct of these tasks and the scientific review of related dossiers particular knowledge on regulatory principles is required.
Regulatory Affairs Professional
Regulatory Affairs professionals are mostly the first point of contact between companies and health authorities. These interactions are of considerable importance and impact for the company. Incomplete and insufficient regulatory submissions to health authorities may result in delay of the evaluation or even rejection of the marketing application of a new candidate medicinal product. At authorities, regulatory affairs professionals are in charge of the review of dossiers of newly submitted applications or life cycle changes. This work is special due to the particularly interesting and challenging discussions and decision on the benefit-risk ratio and final authorisation of new products. The regulatory affairs professional interacts, integrates, communicates cross-functionally, cross-regionally and between companies and authorities. It is an important, increasingly international, exciting and challenging profession offering a wide variety of job responsibilities and requiring particular skills.
Role and responsibilities
- Develop and maintain knowledge of the regulatory guidelines, legislations, requirements, processes and procedures
- Develop and maintain understanding of the company products
- Determine regulatory strategy, risk assessment and risk management
- Interact with colleagues from drug development, marketing, manufacturing, quality control, quality assurance, communication within and outside the organisation
- Provide strategic, scientific and technical advice during pre-marketing phases
- Support post-marketing activities such as compliance and post-marketing surveillance, inspections, audits, labelling and advertising
- Organize, compile and evaluate the quality, safety and efficacy data for the submission of regulatory dossiers to the health authorities
- Submit the dossiers to the health authorities and accomplish the interactions with them during the authorisation phase and thereafter
- Cooperate, communicate and negotiate with internal stakeholders, external contractors, regulatory agencies and trade associations
- Establish and maintain relationships with the health authorities
- Commitment to effective project management
- Organisational and coordination skills
- Negotiation, communication and interpersonal skills
- Understanding and application of regulatory guidelines, legislations, processes and procedures
- Integrative work in multinational, multicultural and multidisciplinary environment
- Analytical, critical and constructive thinking
- Ability to set priorities and meet sharply defined deadlines
- Accurate working and attention to details