07/01/2018

22/01/2018

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 Regulatory Affairs (Pharma/BioPharma) Specialist Diploma is a distance education course. Participants attend face-to-face sessions on three Saturdays a semester and engage in distance education and online learning throughout the programme. While class contact is low there is a significant amount of interaction online.

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.

The majority of companies with a presence in Ireland, have products derived from biotechnology in their portfolio. This course seeks to highlight the key regulatory aspects of biopharmaceuticals along with the mainstream requirements for chemical drugs throughout the modules.

The programme is focussed on the EU regulatory requirements but will also compare these with the main features of regulatory systems in the US, which is the most important other jurisdiction for Regulatory Affairs (RA) professionals based in Ireland.

With increased focus on delivering improvements in manufacturing and logistic processes to improve efficiencies and increase profitability as well as reduce cost of medicines to the patient gaining regulatory approval to enable implementation of the changes is one of the key challenges facing the Health care industry. Highly skilled Regulatory Affairs professionals who can manage this complexity is a key skill need. Ireland is ideally positioned for this activity as it is English speaking, has a very strong technical base and with a focused RA skills training program will be highly valued.

Applicants are normally expected to hold a primary honours degree (minimum H2.2), or equivalent and have at least 5 years of relevant industrial experience.

Alternative Entry Route
Candidates who do not meet the minimum entry criteria can be evaluated under the UL RPL policy and may be interviewed to ascertain their suitability for the programme.

Education qualifications, work experience, motivation and overall potential to be successful on the programme are considered in evaluating an application.

Applicants maybe short listed for interview as part of the application process.

Applicants are required to meet the University of Limerick English Language requirements.

To be eligible for Springboard+ funding applicants must be resident in the state.

For Homemakers and Employed/Self-Employed applicants, the following rules apply :
- must be ordinarily resident in an EU/EEA/Swiss state for at least three of the five years preceding their entry to the programme.
** Note: The period of residency for holders of Stamp 4 or Stamp 4 EU FAM is calculated from the date of receipt of the Stamp 4. Any period of residency in the state before this date will not be taken into consideration ( ie you must hold Stamp 4 for three of the five years preceding)

An overview of non-clinical (animal studies) and clinical (human) requirements is fundamental to understanding the interactions of regulatory affairs with the drug development process for a new active substance; additionally, responsibilities under global clinical development programmes for clinical trial management and pharmcovigilance responsibilities at all stages must be highlighted. However, Irish RA professionals are likely to have minimal interaction with the global clinical development programmes, which are usually tightly managed by specialised medical functions from corporate headquarters.

The interaction of regulatory with the commercial strategy and lifecycle maximisation, involving such topics as commercial out-licensing, own-brand generics, mergers and acquisitions and due diligence, pharmacoeconomics, OTC switching, line extensions, etc. is an enhanced role.

Workload associated with regulatory affairs activities has increased significantly and will continue to increase due to the establishment of stronger regulatory authorities in emerging markets such as Russia, China, Brazil etc. These are key expansion markets for all the major Health care companies with speed to market being a critical business requirement.

Many 'non-biotech' company RA personnel have made the transition to RA from biotech without much difficulty as there is overlap. The reference to 'Pharma/Biopharma' in the title of this course should make the distinction between BioPharmaChem RA and Medical Devices RA clear so as not to mislead, while still attracting the widest pool of prospective students.

Course Modules:

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

Semester 2 (Autumn)
1. Regulatory Requirements for a New Active Substance: Chemical and Pharmaceutical.
2. Regulatory Strategy and Requirements for Established Active Substances.

Distance

Distance

Carmel O'Dwyer

Continuing & Professional Education,
University of Limerick,
Limerick, Ireland

061-202605

cpe@ul.ie

The University of Limerick operates a policy for the Recognition of Prior Learning, both formal and informal/experiential learning. Informal and experiential learning includes non-accredited personal and professional education; work based training and relevant life/work experiences. This learning is assessed initially for entry on to particular courses of study but may additionally lead to academic credits and exemptions from subjects on the intended course of study. Applications for RPL are dealt with on an individual basis, facilitated by representatives from the relevant academic departments and Registrar's office at the University of Limerick. RPL for Springboard 2017 will be managed by Continuing & Professional Education as part of the application process. Continuing & Professional Education provides support and assistance to guide the learner through their RPL application and in compiling their portfolio. The process is student centric, with consideration made on a case-by-case basis, through submitted documentation and communication with the application team and course director.The operation of the RPL policy has been applied successfully to previous cohorts. Academic and professional qualifications, work and life experience are important considerations in assessment, but motivation and overall potential for the selected course has been a major factor in evaluating applicants.

Stage 01: Apply on Springboard Courses to register your interest in taking this course at the University of Limerick.

Stage 02: Start the University of Limerick on-line application process and save it until you have all documentation ready.
(If you are prompted on the UL online application form to pay an application fee of €25, please select the “Pay by Cheque” option to waive this fee. Springboard applicants are exempt from fees.)

Stage 03: Gather the required documentation to support your application as detailed below. Support Documents required with your application:
§ Photo or Scanned original copy of your transcripts/college results. Graduates of UL need only provide us with their Student ID number. We can access their student transcripts using this number.
§ Photo or Scanned copy of passport to verify ID and full legal name.
§ Digital quality head and shoulders photograph to passport standards for your ID card.
§ Any other relevant documentation to support your application, such as a CV or professional certificates.
§ Applicants who do not have English as their first language must include the following additional documents with their application form:
•English translation of your qualification(s)/transcripts
•English language competency certificate
Applicants from non-English speaking countries are required to have a high level of competence in English


These are compulsory documents and are required for enrolment at the University. It can take time to gather these documents so please do so prior to submitting your application.


Stage 04: Upload your documents and submit your application to the University of Limerick On-line Application System. Please note, your application will not be processed until all documentation is received.

Stage 05: The University of Limerick On-line Application System will make you an offer if you are successful.

Stage 06: Accept the University of Limerick On-line Application System Offer.

Stage 07: The Springboard Application System will offer you a place which you should accept to avail of free fees. If you do not you will be liable for fees of €5,250.

In order to avail of Springboard+ funding you must provide written confirmation as follows:

Unemployed:
- Written confirmation from the Department of Social Protection (DSP) that you are a Social Welfare recipient at the commencement of the course.

Homemaker:
- Swear a declaration before a Commissioner for Oaths attesting to your status as Homemaker and provide written proof.

Employed/Self Employed:
- Provide a copy of most recent P60 or other relevant revenue documentation or a letter from their current employer to confirm employment or self-employment.