Medicademy Regulatory Affairs offers training within pharmaceutical regulatory affairs, and at the highest level this may result in:
• Master’s Degree of Pharmaceutical Regulatory Affairs – MPRA, at the University of Copenhagen.
• Diploma in Pharmaceutical Regulatory Affairs or
• Individual training process by attending modules in random order and according to educational needs.
Further, Medicademy also offers seminars, conferences, and separate courses on hot topics of current interest.
Medicademy Regulatory Affairs is a flexible part-time postgraduate programme, which aims to provide the students with an in-depth and up-to-date knowledge of the most important theoretical and practical aspects of regulatory affairs issues related to pharmaceutical and biopharmaceutical products. Also, the programme provides students with a “Regulatory Affairs Platform” of the entire medicinal product lifecycle – from molecule to marketing authorisation and maintenance.
The modules primarily focus on the European environment,but reference is also made to the USA , Japan, and where relevant other countries within the ICH as well as the Major Markets outside the ICH . Moreover, Medicademy offers specific modules on the regulatory affairs environment in the USA , major markets outside the ICH (e.g. the BRIC and MENA countries), medical devices and veterinary regulatory affairs in the EU.
Medicademy Regulatory Affairs is targeted at regulatory affairs professionals, who wish to further develop their experience and knowledge within regulatory affairs by either obtaining a Master’s Degree or a Diploma, or by attending individual modules of own choice. The modules are primarily designed for professionals with at least a relevant Bachelor Degree or similar qualifications and at least 2 years of experience from the pharmaceutical/biotech industry or regulatory health authorities. Applicants, who do not meet the entry requirements, will be considered on a case-by-case basis.
Medicademy Regulatory Affairs has been developed by a team of internationally experienced regulatory affairs experts from the pharmaceutical/biotech industry, the Danish Medicines Agency and researchers from the Faculty of Pharmaceutical Sciences, University of Copenhagen (PHARMA, KU). Through their representation in the Steering Committee and as frequent course leaders and lecturers in the individual modules, all these experts are involved in the continuous development of the programme.
An international faculty of experts from all over Europe, USA , Brazil, Russia, India, China and other non-European countries coming from the pharmaceutical/biotech industry, regulatory authorities and universities carry the teaching responsibility.
Medicademy Regulatory Affairs offers 14 modules, each of 2 – 4 days duration.
Module 1: The Pharmaceutical Law Frames in the EU
Module 2: EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trial and Orphan Drug Designation
Module 3: The Regulatory Affairs Environment in the USA
Module 4: The Regulatory Affairs Environment in Japan
Module 5: Regulatory Strategic Considerations during Global Drug Development
Module 6: Quality – Drug Substance and Drug Product
Module 7: Non-Clinical Development and Documentation
Module 8: Clinical Development and Documentation
Module 9: Product Life Cycle Activities
Module 10: Biopharmaceuticals – Quality Development and Documentation
Module 11: Role and Responsibilities of a Regulatory Affairs Professional
Module 12: Medical Devices – Drug/Device Combinations
Module 13: The Regulatory Environment in Major Markets outside ICH – Optimizing Your Regulatory
Strategy in the BRIC countries (Brazil, Russia, India and China)
Module 14: Veterinary Regulatory Affairs in the EU
All modules are offered within a time period of 1 – 1½ years, some modules more often depending on demand, interest, and need.
The actual learning activities include class teaching, self-studies, interactive discussions, case studies and workshops. Each module is concluded with an examination approximately 4 weeks after the module. Please note that examinations can be sat in any country!
English is the principal language of instruction in all Medicademy modules, and learning activities include class teaching, lectures, self-studies, interactive discussions, case studies, “real life” experiences, and workshops.
Course materials include relevant literature, guidelines, directives, regulations, articles, and links to
relevant web-sites. All materials will be available to students electronically approximately 4 weeks prior to attendance and must be read before module start-up. Medicademy class teaching is interactive and students are expected to participate actively.
The faculty consists of experts drawn worldwide from the Pharmaceutical/Biotech Industry, Authorities and Universities.
Each module has two course leaders. The course leaders are responsible for identifying qualified lecturers, collecting course materials, and for examining students. Further, course leaders are responsible for the professional framework of the module and involved in the continuous development of the entire Medicademy programme.
Stine Folkenberg Hedegaard
Stine Folkenberg Hedegaard is E-learning Manager and responsible for e-learning, communication, marketing and a number of courses.
Helle Rishøj Nielsen
Helle Rishøj Nielsen is Payroll Officer and is responsible for payroll, travel arrangements, evaluations, diplomas and certificates, etc.
Minna K. Jørgensen
Minna Kjær Jørgensen is Program Director, Medicademy Pharmacovigilance and also responsible for Introduction to Safety & Pharmacovigilance and Medical Advertising Standards.
Tina Jensen is Program Director, Medicademy Regulatory Affairs and responsible for Introduction to Drug Registration.
Henrik Køhler Simonsen
Henrik Køhler Simonsen is Head of Department and Head of Lif Education, Lif Exhibition and Medicademy.
Lif Education, Diploma in Basic Pharmaceutical Medicine, Clinical Research, Drug Development, Medicademy Pharmacovigilance, Medicademy Regulatory Affairs, RA, PV, Pharmacovigilance, Regulatory Affairs