Regulatory Affairs in (Bio)Pharmaceuticals (Specialist Diploma) (Blended Learning) (January 2021)

University of Limerick (21SDRABPTPBD)
Key Programme Details
Award

Minor

NFQ Level

Level 9 About NFQ

Delivery Method

Online, Blended

Mode

Part Time

ECTS Credits

42

Department

Chemical Sciences

General Information
Contact

Ask for a Springboard+ Co-ordinator

Email

springboard@ul.ie

Phone

061-202605 or 061-234379

Address

Graduate & Professional Studies
University of Limerick
Limerick
V94 T9PX

Role

Springboard+ Co-ordinator

Important Dates
Application Deadline

01/12/2020

Start Date

25/01/2021

End Date

18/12/2021

About this Course

This course starts in January 2021. Applications will open later this year, around late October/early November 2020. If you wish to be added to an expression of interest list and thus be contacted when we open applications please email on: springboard@ul.ie and ask to be added to this list.

The Specialist Diploma in Regulatory Affairs [RA] in (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.

Given the current environment this course is planned to be delivered in line with the Universities strategy on dealing with the ever evolving COVID19 situation. As a result, this course will now be delivered in a part-time blended format for Semester 1 at least.

For updates on the impact of COVID19 on delivery please consult this section of the University of Limerick website:
https://www.ul.ie/covid-home

Please note we will need to correspond with you by email throughout the application process. For this reason, we ask that you regularly check your email and spam folders.

Objectives

The last decade has seen an increasing demand in Ireland and globally for Regulatory Affairs (RA) professionals within the pharmaceutical industry. There are a number of factors contributing to this, including the dramatic increase in (bio)pharmaceutical manufacturing presence both regionally and nationally.

In the past RA roles were often located in the UK or another European hub; however, multinationals have realised, over the last decade in particular, that there are distinct advantages in co-locating an RA presence at their manufacturing or distribution site in Ireland. These benefits are relevant in terms of facilitating tech transfers and maintaining local marketing authorisation compliance but progressively, the impact of the contribution of the Irish RA professionals to global regulatory projects and strategies came to be recognised.

Entry Requirements

Applicants are normally expected to hold a primary honours degree (NFQ level 8, minimum H2.2) in a Science, Technology, Engineering, Mathematics, Manufacturing and Design (STEMMD) discipline or equivalent and have at least 1 year of experience in a regulatory role or 2 years of relevant pharmaceutical industry experience.
Applicants education qualifications, work experience; particularly in regulation, validation or compliance or other related fields, their motivation and overall potential to be successful on the programme will be considered in evaluating an application.

Alternative entry route candidates, who do not meet this minimum entry criteria will be evaluated under the UL Recognition of Prior Learning policy (RPL)and any candidates may be interviewed to ascertain their suitability for the programme.

Not all eligible candidates may be offered a place on the programme.

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


Long Description

This Specialist Diploma is available to job seekers and graduates with a background in quality, manufacturing, pharmaceutical, biopharmaceutical or regulated 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.

All delivery is by industry representatives who engage in a series of workshops and case studies, as well as talks on specific RA topics from an industry perspective. These professionals are members of TOPRA [The Organisation for Professionals in Regulatory Affairs], as well as holding key RA roles in companies or regulatory organisations. Availing of working professionals to deliver the material ensures good content delivered with enthusiasm by people knowledgeable and passionate about their subject.

In the 2019 delivery 21 industry professionals collaborated to delivery the 5 topic specific modules. This industry exposure was positively commented on by participants in the review. UL worked closely with TOPRA, SSPC, BPCI and industry to ensure that the design of the programme is appropriate to the needs on industry as outlined in the Mid-West Action Plan for Jobs and the advice of the Regional Skills Manager.

MODULES:
Drug Regulation and the Agencies.: Areas covered: Legal basis for regulation of medicines, Legal framework for Clinical trials in EU
Regulatory Affairs Interactions in Drug Development & Product Marketing.
Key Regulatory Considerations for Non-clinical and Clinical Development and Clinical Operations.
Regulatory Requirements for a New or major changes to an Active Substance: Chemical and Pharmaceutic
CA4003 Career Development: Optional module for those students who wish to pursue this professional development workshop. Which prepare learners with CV and career coaching, develop a LinkedIn/online presence, physical presentation and interviews skills.
IE2011 Industry Learning Project: Optional module for unemployed students who require a placement in the area of course study.

Timetable Info

Timetable to be advised. This is traditionally a Part Time course where classes are delivered over a few Saturdays a semester.
Due to the current situation regarding Covid-19 restrictions, the University is planning to deliver courses on a blended basis. Exact details will be confirmed closer to the time.

For updates on the impact of COVID19 on delivery please regularly consult this section of the University of Limerick website:
https://www.ul.ie/covid-home

Delivery Notes

Blended

Admissions Contact Details
Contact Person

Ask for a Springboard+ Co-ordinator

Address

Graduate & Professional Studies
University of Limerick
Limerick
V94 T9PX

Phone

061-202605 or 061-234379

Email

springboard@ul.ie

RPL Information

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+ 2020 will be managed by Graduate and Professional Studies as part of the application process. Graduate & Professional Studies 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.

Application Procedures

APPLICATION TO A SPRINGBOARD+ COURSE WITH THE UNIVERSITY OF LIMERICK IS A 2 STEP PROCESS.

Step 1 is to submit your application on the Springboard+ website, you will then be sent a link via email to apply to the University of Limerick (UL) directly (this will be step 2).
You must provide all documents requested on this email which must be uploaded with your application on the UL site. It is only when we receive ALL requested documents that your application is considered complete.

Note : It may take a few days after your application is updated to 'Pending' on the Springboard+ website before you receive the email containing the link to apply to UL (step 2).


Please note we will need to correspond with you by email throughout the application process. For this reason, we ask that you regularly check your email and spam folders.

Required Documents for UL application:
Delays in receiving these documents will affect the progress of your application.
- Photo or Scanned original copy of your transcripts for all years of study. (Graduates of UL need only provide us with their Student ID number.)
- Photo or Scanned copy of passport to verify ID and full legal name.
- Digital quality head and shoulders photograph.
- A copy of your most recent CV, please note that by providing this document you are agreeing that we may send it to members of industry if you require assistance when searching for an Industry Learning Placement (ILE) or project work (applies to some courses only).
- Applicants who do not have English as their first language may satisfy English Language
requirements:
• If your qualifications have been obtained in a country where English is an official language this will suffice
If this is not available, the following additional documents must be provided:
• English translation of your qualification(s)/transcripts
AND
• English language competency certificate


FEES - EMPLOYED APPLICANTS ONLY
All employed participants must pay a contribution of the course cost directly to the provider for all level 7-9 courses. The onus is on the participant to arrange payment of this fee. The HEA will fund the remainder of the cost directly to the provider.

Employed participants will be required to make a 10% course contribution of €525 directly to the University of Limerick.

Springboard+ will pay all fees for unemployed and returner participants.

Course Acceptance
Should an offer be made, in order to accept a course offer employed participants must pay a non-refundable acceptance fee of €250 to the University of Limerick. This €250 will be deducted from the contribution of €525 as outlined above. The full fees of €525 are due in two equal instalments which is €262.50. Once the €250 acceptance has been paid then the remaining fee for semester 1 of €12.50 is due by 4th September 2020. The remaining €262.50 is due by 15th January 2021.

In order to avail of Springboard+ funding you must provide written proof as outlined below:

NOTE: If your employment status changes during the application process it is your responsibility to inform a Springboard+ coordinator at UL and to provide proof of new status.

Unemployed
Written proof from the Department of Employment and Social Protection (DEASP) that you are in receipt of an eligible payment (see Springboard+ site).

Returners
Swear a declaration before a Commissioner for Oaths attesting to your status 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.

Formerly Self-Employed
Provide a letter/statement from Revenue stating that the applicant is no longer trading or a similar letter from the applicants (former) accountant should be sufficient. Swear a declaration, witnessed by a Commissioner of Oaths, stating that the applicant is no longer self-employed.

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

Please note you may be required to verify your Nationality and Residency status.

For Returners 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)