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

12/2018

Start Date

21/01/2019

End Date

21/12/2019

About this Course

The Specialist Diploma in Regulatory Affairs (Bio)Pharmaceutical 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 (Bio)Pharmaceutical 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 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.

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.

The programme is focussed on the EU regulatory requirements but will also compare these with the main features of regulatory systems in US, which is the most important other jurisdiction for RA professionals based in Ireland.
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.
While many “non-biotech” company RA personnel have made the transition to RA form 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.

Objectives

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.

Entry Requirements

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.

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 (Bio)Pharmaceutical
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.
3. Industry Learning Project

Structure: The programme comprises five Taught Modules, a Job Readiness Programme and an Industry Learning Experience.

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.

Job readiness and support into employment will be provided through a series of workshops and seminars and an active engagement with motivated students in attaining employment. An optional Career Development module (CA4003) will be offered to all participants in this course.

An industry learning experience (IE2011) will form a key element of the programme, ensuring the integration of the various concepts in the participant’s portfolio. 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 applications should ensure their company would be willing to support an in-company project, it is assumed applicants could base their project on their company.

Timetable Info

Approx. 6 hours per week - Weekend
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 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.

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 then you need to take this step.

- 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 €450 as outlined above. The balance of this contribution fee (€200) 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 Employ Social Protection (DEASP) that you are a Social Welfare recipient 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)