Postgraduate Diploma in Science in Pharmaceutical Regulatory Affairs
Delivered jointly by the Royal College of Surgeons in Ireland and IT Sligo
Programme Code: SG_SREGU_O09
About Pharmaceutical Regulatory Affairs
Regulatory affairs specialists play an important role in the pharmaceutical industry and there is currently no dedicated training programme in Ireland suitable for those who would like to enter this field or who are working in the area but want to develop their knowledge and skills. The course is being made available in part‐time distance learning format.
About this Programme
The full suite of six modules (60 credits) will normally take two academic years to complete. Participants may also take individual modules, at his/her own pace, receive credits on successful completion of each module and eventually receive sufficient credits to be awarded a Postgraduate Diploma in Science in Pharmaceutical Regulatory Affairs.
Programme curriculum
The programme is organised around a two-year cycle, during which 6 modules are studied. Each year is split into two semesters and one-two modules are delivered in parallel during each semester.
The individual modules are as follows:
- Regulatory processes and procedures
- Development of medicinal products.
- Authorisation process for medicinal products
- Biological products
- Quality and safety
- Supply, sales and marketing
Full details of these modules are available here in our official programme documentation.
After you Graduate
The programme objectives are to produce graduates with the essential breadth and kind of knowledge, skills set and competences required to function as a regulatory affairs officer in the pharmaceutical industry and to be capable of an immediate contribution to regulatory projects in a pharmaceutical company environment.
Entry Requirements
The programme is open to students who have obtained a Level 8 Honours Degree or its equivalent in an appropriate discipline (i.e. a science subject related to the pharmaceutical sciences). Other candidates with alternative Honours Degrees and experience in regulatory affairs shall be considered on a case-by-case basis. The entry requirements will encompass recognition of prior accredited learning in other third level institutions, in accordance with procedures under development by IT Sligo.
Award: Level 9
Duration: 2 years
Fees: €5,000 per year
Application Deadline: 15 October 2010
Delivery: Online, Distance with RCSI
FURTHER INFORMATION
The School of Science
Tel: 071 91 55222
Email: parttime@itsligo.ie