Regulatory Affairs- Specialist Diploma

The Specialist Diploma in Regulatory Affairs (Pharma/BioPharma) benefits those in the early stages of a regulatory career or seeking to transition from another function, as well as more experienced professionals seeking to enhance their knowledge or formalise their learning. The topics and syllabus are designed to encompass the core knowledge, along with those aspects of regulatory affairs with the widest relevance to the industry in the Irish setting.
This Specialist Diploma is available to job seekers and graduates with a background in quality, manufacturing, pharmaceutical, biopharmaceutical or chemical sectors. It is for those with an interest in organisational improvement and development through the use of Regulatory Affairs tools and techniques.
The course is for graduates who would like to learn about the EU regulatory requirements, as well as the main features of the regulatory system in the US, which is the most important other jurisdiction for RA professionals based in Ireland.
See Module Flyer here 
 
TOPICS AND MODULES COVERED
Semester 1 (Spring)
1. Drug Regulation and the Agencies.
2. Regulatory Affairs Interactions in Drug Development & Product Marketing.
3. Key Regulatory Considerations for Non-clinical and Clinical Development and Clinical Operations.
4. Career Development (Optional)
Semester 2 (Autumn)
1. Regulatory Requirements for a New Active Substance: Chemical and Pharmaceutical.
2. Regulatory Strategy and Requirements for Established Active Substances.
 
 
Each learner will participate in ‘Job Readiness’ & ‘Support into Employment‘ workshops, to develop their confidence and interview skills, as well as CV development and career development.
Industry representatives will engage in a series of  presentations on employment opportunities in the region, as well as talks on specific RA topics from an industry perspective. In the second semester there will be the opportunity for course participants to apply for work placement with our industry partners. The number of in-company work placements offered depends on the student’s location, topic area and motivation to participate in all elements of the course. A work placement manager will work with participants and companies to find the best fit but the onus is on the learner to play an active role in this process.
 
An optional Career Development module (CA4003) will be offered to all participants in this course.
 
An optional module Industry Learning Experience (IE2011) is available. This module ensures the integration of the various concepts taught throughout the course. While the onus is on the student to find a company in which to gain their industry learning experience, assistance will be provided where required. Employed applicants should ensure that their employer would be willing to support an in-company project, it is assumed that applicants could base this project on their company.

HOW TO APPLY

Applicants are encouraged to register and apply online via the Springboard website. Applicants must ensure that they are eligible to apply for Springboard funding for this course, by clicking on the ‘Am I Eligible?’ tab on the front page of the Springboard website. This site also contains full details on the documents you need to gather before you begin your application. Applications open on September 28th 2018
Visit www.springboardcourses.ie for more details.

CONTACT INFORMATION

For application queries, please email springboard@ul.ie
     

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