Certificate in International Regulatory Affairs (Postgraduate) (Certificate in International Regulatory Affairs (Postgraduate))

South East Technological University (WD_SINTR_MA)
Key Programme Details
Award

Certificate in International Regulatory Affairs

NFQ Level

Level 9 About NFQ

Delivery Method

Blended

Mode

Part Time

ECTS Credits

10

Department

School of Science

General Information
Contact

Lorraine Quirke

Email

Lorraine.Quirke@setu.ie

Phone

051834137

Address

LORRAINE QUIRKE
SPRINGBOARD ADMINISTRATOR
SCHOOL OF EDUCATION & LIFELONG LEARNING
SOUTH EAST TECHNOLOGICAL UNIVERSITY
WATERFORD
X91 KOEK

Role

Springboard Administrator

Important Dates
Application Deadline

16/09/2022

Start Date

16/01/2023

End Date

16/05/2023

About this Course

This level 9 module is designed for those who have experience of working in an industrial quality/manufacturing environment, who wish to upskill in the core area of Regulatory affairs. The overall aim of the module is to produce graduates with the necessary knowledge, skills and expertise in the area of pharmaceutical regulation and licensing to enable them to progress their career in this fast growing area. Due to increasing degree of regulation in all areas of pharmaceutical industry from pharmaceutical development through to manufacture, sale and supply there is an acute shortage of trained personnel in this area.

Specifically, the aims of the Postgraduate Certificate in International Regulatory Affairs is to educate students in the role of a regulatory affairs professional with the skills to develop and implement regulatory strategies, understand and manage the submission and maintenance of Marketing Authorisation applications and post approval submissions.

The module will cover the regulatory framework, legal basis of applications, regulatory agencies, structure and content of regulatory submission to Europe and export markets and pharmacovigilance. The student will gain a detailed understanding of requirements to comply with legislation in terms of regulatory submissions and pharmacovigilance.
On successful completion of this module, a student will be able to


1. Plan and implement the most appropriate regulatory strategy to achieve the companys objectives in terms of licensing of products.

2. Advise the company in relation to compliance at all stages of the development life cycle to development through to marketing and sales.

3. Prepare and submit Marketing Authorisation applications.

4. Manage post approval submissions for Marketing Authorisations including transfers, Variations and renewals.

5. Understand and implement the procedures to be followed to comply with Good Vigilance Practice.

There is significant industry interest in this rapidly growing area with courses being oversubscribed over the past several years. Applicants from both local and national companies have participated with full support from their management with positive feedback from local industries confirming the applicability of the course to the industry requirements.

On-going discussions with Industry leaders on the benefits of broader industrial experience to a regulatory affairs professional assists in the identification of the most suitable candidates in the screening of applicants. Queries from Industry leaders have been received on an ongoing basis to enquire on availability of experienced graduates in this field. In Feb 2022, 28 positions for regulatory affairs professionals were advertised in Indeed.ie and many others identified in a Linked in Ireland . Over the next few years the demand for trained personnel will increase and this course prepares the graduates with the grounding on which to build a successful career in this discipline.

Module (10 credit)
Certificate in International Regulatory Affairs



Entry Requirements

Applicants for entry to this programme should hold a bachelor's degree at honours level minimum 2.2 (Level 8) in an appropriate subject area or equivalent qualification. In addition, in order to fully benefit from the programme, it has been deemed desirable to have a minimum of two years relevant industrial experience. Level 7 graduates may use the RPL process to apply for the course and thereby upskill to Level 8.

Applicants whose first language is not English must submit evidence of competency in English, please see WITs English Language Requirements for details.

Long Description

This level 9 module is designed for those who have experience of working in an industrial quality/manufacturing environment, who wish to upskill in the core area of Regulatory affairs. The overall aim of the module is to produce graduates with the necessary knowledge, skills and expertise in the area of pharmaceutical regulation and licensing to enable them to progress their career in this fast growing area. Due to increasing degree of regulation in all areas of pharmaceutical industry from pharmaceutical development through to manufacture, sale and supply there is an acute shortage of trained personnel in this area.

Specifically, the aims of the Postgraduate Certificate in International Regulatory Affairs is to educate students in the role of a regulatory affairs professional with the skills to develop and implement regulatory strategies, understand and manage the submission and maintenance of Marketing Authorisation applications and post approval submissions.

The module will cover the regulatory framework, legal basis of applications, regulatory agencies, structure and content of regulatory submission to Europe and export markets and pharmacovigilance. The student will gain a detailed understanding of requirements to comply with legislation in terms of regulatory submissions and pharmacovigilance.
On successful completion of this module, a student will be able to

1. Plan and implement the most appropriate regulatory strategy to achieve the companys objectives in terms of licensing of products.

2. Advise the company in relation to compliance at all stages of the development life cycle to development through to marketing and sales.

3. Prepare and submit Marketing Authorisation applications.

4. Manage post approval submissions for Marketing Authorisations including transfers, Variations and renewals.

5. Understand and implement the procedures to be followed to comply with Good Vigilance Practice.

There is significant industry interest in this rapidly growing area with courses being oversubscribed over the past several years. Applicants from both local and national companies have participated with full support from their management with positive feedback from local industries confirming the applicability of the course to the industry requirements.

On-going discussions with Industry leaders on the benefits of broader industrial experience to a regulatory affairs professional assists in the identification of the most suitable candidates in the screening of applicants. Queries from Industry leaders have been received on an ongoing basis to enquire on availability of experienced graduates in this field. In Feb 2022, 28 positions for regulatory affairs professionals were advertised in ˜Indeed.ie and many others identified in Linked in Ireland. Over the next few years the demand for trained personnel will increase and this course prepares the graduates with the grounding on which to build a successful career in this discipline.


Career Opportunities

This programme can be taken as a stand-alone Certificate worth 10 credits at level 9, or if the student wishes, they can use these credits
towards the 60 credit Postgraduate Diploma in Analytical Science with Quality Management (WD 519) or the 90 credit MSc in Analytical
Science with Quality Management (WD 520).
This course places a strong emphasis on the professional development of the graduate and is aimed at students already working in an
industrial environment. Such a qualification will enable and facilitate career progression for graduates in the region.

Timetable Info

Delivery

The indicative delivery model for the Certificate in International Regulatory Affairs (Postgraduate ) module for the 2022/23 academic year is that the course will be delivered via blended delivery : January to May'2023. Two days per month, with 1 full day only required on the SETU Waterford campus with the remainder of the classes taking place on-line.

Delivery Location

SOUTH EAST TECHNOLOGICAL UNIVERSITY
CORK ROAD
WATERFORD
X91 KOEK

Delivery Notes

Delivery

The indicative delivery model for the Certificate in International Regulatory Affairs (Postgraduate ) module for the 2022/23 academic year is that the course will be delivered via blended delivery : January to May'2023. Two days per month, with 1 full day required on the SETU Waterford campus the remainder of the classes taking place on-line.

Admissions Contact Details
Contact Person

Lorraine Quirke

Address

LORRAINE QUIRKE
SPRINGBOARD ADMINISTRATOR
SCHOOL OF EDUCATION & LIFELONG LEARNING
SOUTH EAST TECHNOLOGICAL UNIVERSITY
WATERFORD
X91 KOEK

Phone

051 834137

Email

Lorraine.Quirke@setu.ie

RPL Information

Recognition of Prior Learning - SETU Waterford Campus | formerly Waterford Institute of Technology (wit.ie)

Application Procedures

Application Procedures:
Apply via www.springboardcourses.ie . It is important that you support your application with the following required electronic/scanned copies of supporting documents :

1. An up-to-date CV.

2. Scanned copies of all of your official educational qualification, parchments or a transcript of the results showing the results you achieved in each module.

3. Those in receipt of a qualifying Department of Social Protection payment will be required to provide evidence of this payment (Pay slip or letter ).


• Returners: will be required to provide a letter / statement signed by a Commissioner of Oaths confirming their status as a homemaker.

• Employed candidates: are required to provide proof or employment . This can include a recent copy of the following : a pay slip, letter or statement from revenue demonstrating your current employment .

• Self - Employed : a recent letter from your solicitor or accountant confirming your self - employment status.

4. Proof of Identification , a copy of your passport or driving license.

5. Applicants whose first language is not English must submit evidence of competency in English, please see WITs English Language Requirements please see: www.wit.ie/englishrequirements

* To take a course through Springboard+ you will need to:
1. be living fulltime in the Republic of Ireland
2. have your own, valid PPS Number
3. meet the nationality/visa requirement
• You are an EU/EEA/UK/Swiss national or:
• You have permission to remain in Ireland as a family member of an EU citizen or;
• You have Stamp 4 or Stamp 4 EU FAM on your GNIB residence card or;
• You have official refugee status in Ireland / are here on the basis of refugee family reunification or;
• You have been granted Humanitarian Leave to Remain in the State (prior to the Immigration Act 1999) or;
• You have permission to remain following the Minister’s decision not to make a deportation order.
4. have lived in either the EU, the EEA, the UK or Switzerland for at least 3 out of the last 5 years
• If you are a Stamp 4 or Stamp 4 EU FAM holder, residency is calculated from the date you received your stamp. Any time before this cannot be counted
• If you have refugee status in Ireland, residency is counted from the date you applied for International Protection

Media

Springboard+ Courses 2021/22 - SETU Waterford Campus | formerly Waterford Institute of Technology http://(wit.ie)