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

Waterford Institute of Technology (SINTR )
Key Programme Details
Award

Certificate in International Regulatory Affairs (Postgraduate)

NFQ Level

Level 9 About NFQ

Delivery Method

Online, Classroom, Blended

Mode

Part Time

ECTS Credits

10

General Information
Contact

Lorraine Quirke

Email

springboard@wit.ie

Phone

00353 51 834137

Address

School of Education and Lifelong Learning
Waterford Institute of Technology
Main Campus, Cork Road
Waterford
Ireland

Role

Springboard Administrator

Important Dates
Application Deadline

22/10/2021

Start Date

14/01/2022

End Date

20/05/2022

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.

Module
Certificate in 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. please see: www.wit.ie/englishrequirements

Long Description

This level 9 award 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 licencing 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 and post approval submissions.
4. Understand and implement the procedures to be followed to comply with Good Vigilance Practice.

Career Opportunities

On successful completion of this module, a student will be able to
1. Plan and implement the most appropriate regulatory strategy to achieve the company’s objectives in terms of
licencing 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 and post approval submissions.
4. Understand and implement the procedures to be followed to comply with Good Vigilance Practice.

Timetable Info

The course is run over four weekends (Fri and Sat) between Jan and April.
Two days will be on site on the main WIT campus with remainder on line.

Delivery Location

Waterford Institute of Technology
Main Campus, Cork Road
Waterford
Ireland

Delivery Notes

The program will run over four weekends(Friday and Sat) between Jan and April.
On-site lectures will be held on two days with remote online classes for the other days.

Admissions Contact Details
Contact Person

Lorraine Quirke

Address

School of Education and Lifelong Learning
Waterford Institute of Technology
Main Campus, Cork Road
Waterford
Ireland

Phone

051834137

Email

springboard@wit.ie

Application Procedures

Apply via: www.springboardcourses.ie