Regulatory Affairs in (Bio)Pharmaceuticals (Specialist Diploma) [January 2019]

University of Limerick (19SDQURA)
Key Programme Details
Award

Minor

NFQ Level

9 About NFQ

Delivery Method

Classroom - Daytime, Distance

Mode

Part Time

ECTS Credits

42

Department

Chemical Sciences

Skills Area

Engineering, manufacturing and construction

General Information
Contact

Ask for a Springboard Co-ordinator

Email

springboard@ul.ie

Phone

061-202605 or 061-234379

Address

Graduate & Professional Studies (formerly CPE)
ER1-030
Enterprise Research Centre
University of Limerick
Castletroy
Limerick
V94 T9PX

Role

Springboard+ Co-ordinator

Important Dates
Application Deadline

16/11/2018

Start Date

02/02/2019

End Date

21/12/2019

About this Course

This Springboard+ course will open for applications on Friday September 28th 2018 at 1pm

The Specialist Diploma in Regulatory Affairs in (Bio)Pharmaceuticals 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 in (Bio)Pharmaceuticals Specialist Diploma is a distance education course. Participants attend face-to-face sessions on three Saturdays per semester (there are two semesters in total) and engage in distance education and online learning throughout the programme.

There is a strong demand in recent years for Regulatory Affairs (RA) professionals within the biopharmaceutical and pharmaceutical industries. RA professionals carry out a pivotal role in ensuring the provision of safe and effective medicines. This intensive programme was developed with input and presentations from European Regulatory Authorities, including the Irish Health Products Regulatory Authority (HPRA), TOPRA (The Organisation for Professionals in Regulatory Affairs) as well as the European Commission. The topics and syllabus are designed to give a complete overview of the role of the Regulatory Professional in the (bio) pharmaceutical industry and will suit anybody with an interest in moving into the area of regulatory affairs who has worked in the industry or who has a suitable qualification, or for those who are currently working in the area and who wish to formalise their learning with a qualification.

The course commences with an overview of the legal basis for the regulation of medicines and covers interactions with the regulatory agencies and global collaborations. Whilst some of the areas covered on the course can be functions that Irish Regulatory Professionals may have minimal involvement in, it is important that these functions are covered. This will fully inform delegates of the overall scope of the role of the Regulatory professional, enabling them to see how their role in Ireland fits in the global picture. Fundamental topics that will also be covered therefore are the considerations for non-clinical (animal studies) and clinical (human) development and clinical operations, the need for a solid regulatory strategy early on, Scientific Advice, Medical Information, Pharmacovigilance, EU innovations for specific products, eg paediatric plans, orphan drugs etc. The course will cover the fundamentals of pharmaceutical development (both traditional and biotech), the role of quality and how it fits in the overall development plan. Manufacturing considerations and the European filing procedures, namely the Centralised, Decentralised and Mutual Recognition Procedures as well as national authorisations will also be discussed in detail. The interaction of regulatory with the commercial strategy, generic medicines and lifecycle maximisation involving Over The Counter (OTC) switching, line extensions, patents, data exclusivity will also be discussed. Maintenance of the product licences will be covered in terms of variations and renewals. There will be a leadership and confidence building aspect to the course to help Regulatory Affairs (RA) professionals to enhance their future career prospects. The programme is focussed primarily on EU regulatory requirements but will also compare these to the US regulatory system, which is the most important other jurisdiction for RA professionals based in Ireland. Whilst many RA personnel have made the transition from non-biotech to biotech without much difficulty (as there is overlap), the reference to bio/pharma in the title of the course should make the distinction between Medical Devices RA clear, so as not to mislead, whilst still attracting the widest pool of prospective students.

To assist you with the application process, you can quickly check if you are eligible for Springboard+ funding by taking this:
Self Checker Quiz
This will clarify your eligibility status. If you are NOT eligible and you are unclear as to the reason why, you can clarify this decision on www.springboardcoures.ie/eligibility or contact a Springboard Administrator within the University of Limerick on springboard@ul.ie

Objectives

Gaining drug regulatory approval/early market access can have significant benefits to an organisation in terms of cost saving and sales. Early approval to both market the drug, and to enable implementation of compliance changes, is a key challenge facing the healthcare industry. Highly skilled RA professionals who can manage these often complex tasks are in high demand. 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. This intensive programme was developed with input and presentations from European Regulatory Authorities, including the Irish Health Products Regulatory Authority (HPRA), TOPRA (The Organisation for Professionals in Regulatory Affairs) as well as the European Commission.

Entry Requirements

Applicants are normally expected to hold a relevant Level 8 primary honours degree (minimum H2.2), or an equivalent qualification, and have at least 1 year of relevant industry experience.

This Specialist Diploma is available to graduates with a background in Pharmaceutical Science, Pharmacy, Regulatory Affairs, Clinical Science/research, Medicine, Quality, Compliance, Manufacturing, Biological Sciences, Biotechnology or other science related discipline. It is designed for graduates who would like to learn about the regulation of medicines and the impact of and need for their regulation.


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

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

See acceptable list of English proficiency qualifications:

UL English Language Requirements

See when English Proficiency Exams can be taken in the University of Limerick:

UL English Language Test details

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)

Long Description

Specialist Diploma in Regulatory Affairs in (Bio)Pharmaceuticals

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.


Structure: The programme comprises five Taught Modules and a mandatory Career Development day.
A Job Readiness Programme and an Industry Learning Experience will also be offered to interested students.

Content: Taught Modules:

1. Drug Regulation and the Agencies. Areas covered: Legal basis for regulation of medicines, Legal framework for Clinical trials in EU, Status Quo and Impending CT Regulation, Protection of the patient – ethics, EU Regulatory Innovations for specific products, Interactions of regulatory affairs with EU agencies, Pre-submission advice (Scientific & procedural), Agency meeting packages, oral hearings, responses to questions, Post-approval: Variations, Agency meetings etc.International collaborations, The US Regulatory Environment Overview, Other key global regulatory bodies
2. Regulatory Affairs Interactions in Drug Development & Product Marketing. Areas covered: Overview of traditional drug development process, Fundamentals of pharmaceutical development, Manufacturing considerations, Pivotal role of Regulatory Affairs, Medical information and the EU regulations.
3. Key Regulatory Considerations for Non-clinical and Clinical Development and Clinical Operations. Areas covered: The need for pharmacology, pharmacokinetic and toxicology data, Outline of the various types of clinical studies, The key strategic and operational issues in the clinical trial process, in terms of legislative requirements and GCP, Overview of pharmacovigilance responsibilities and risk management throughout drug development and lifecycle.
4. Regulatory Requirements for a New or major changes to an Active Substance: Chemical and Pharmaceutical. Areas covered: Role of Quality (Chemical, Biological and Pharmaceutical) data in the overall drug development programme, EU regulatory filing procedures, Centralised, Decentralised, and Mutual Recognition (MRP) procedures, Practical issues with FDA applications, Management of Regulatory inspections arising from Pre Approval Applications.
5. Regulatory Strategy and Requirements for Established Active Substances. Areas covered: Intellectual Property and Lifecycle Considerations (Quality documentation requirements for Generics and Abridged applications Overview of specialised product data requirements, such as: Inhalations, Radiopharmaceuticals, Blood products, Herbals, Drug-device combinations.

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.

Timetable Info

3 Saturdays per semester for a full days session.
Schedules will be made available closer to the course start date.

Delivery Location

University of Limerick

Delivery Notes

Distance

Admissions Contact Details
Instructor

Ask for a Springboard Co-ordinator

Address

Graduate & Professional Studies (formerly CPE)
ER1-030
Enterprise Research Centre
University of Limerick
Castletroy
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+ 2018 will be managed by Graduate and Professional Studies (formerly 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.

Application Procedures

To assist you with the application process, you can quickly check if you are entitled to Springboard+ funding by taking this:
Self Checker Quiz which will advise you of your eligibility status.


Please note that you will need to provide all of the below listed documentation to support your application to the University of Limerick. This application to UL is separate to your Springboard+ application. You will be advised when you need to apply to UL.

- Photo or Scanned original copy of your transcripts/college results. Graduates of UL need only provide their Student ID number. We can access 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 (if applicable)

You will need to provide a satisfactory result in one of below:
See acceptable list of English Proficiency qualifications:

UL English Language Requirements

See when English Proficiency Exams can be taken here in UL

UL English Language Test details

These are compulsory documents and are required for enrolment at the University. It can take time to gather these documents so please do so once you have established that you are eligible for Springboard+ funding.

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.

The Springboard+ course cost for the Specialist Diploma in Regulatory Affairs in (Bio)Pharmaceuticals for is €5,250. Employed participants will get a Springboard+ subvention of €4,725 and will have to make a contribution of €525.

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

Course Acceptance
In order to accept a course offer employed participants must pay an acceptance fee of €250 to the University of Limerick. This €250 will be deducted from the contribution of €525 as outlined above. The balance of this contribution fee (€275) can be paid at the beginning of the January 2019 Semester.

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

Unemployed
Written confirmation from the Department of Employment Affairs and Social Protection (DEASP) that you are in receipt of one of the approved payments from this department at the commencement of the course.
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)