Quality & Regulatory Practice in the Pharmaceutical Industry

Overview
An accredited QQI Level 9 postgraduate award to help you grow in the pharmaceutical industry.

This modular course, awarding a Level 9 certificate, aims to introduce learners to the quality systems and the regulatory framework that assures the quality, safety, and efficacy of medicinal products in the pharmaceutical industry.

Why Study Quality and Regulatory Practice at Griffith College?
The Certificate in Quality and Regulatory Practice in the Pharmaceutical Industry programme aims to:
• demonstrate the importance of pharmaceutical quality,
• provide key information pertaining to quality approaches that apply to the development, manufacture, and supply of medicines, and to
• enable learners to understand the regulatory framework that underpins pharmaceutical product development from discovery through pre-clinical research, clinical trials, registration and release,
• give learners an insight into the costs to the organisation of poor quality, how they are handled and appropriate strategies to mitigate against the risks.
• provide an overview of the evolution of product profile; pharmaceutical quality, quality improvement and risk management practices in manufacturing (GMP) and supply.

Why work in the Pharma industry in Ireland?
• All of the world's Top 10 pharmaceutical companies have substantial operations in Ireland.
• There are over 30,000 people working in the biopharma industry in Ireland today, with the same number of jobs supported indirectly. (Collins McNicholas', Biopharma Report 2020).
• In 2019, Ireland's largest category of exports was medical and pharmaceutical products, 30% of total exports, an increase of 7% on 2018 to a figure of €49,655 million. (CSO statistical release, 14 February 2020).
• Ireland is the 3rd largest exporter of pharmaceuticals globally. (IDA, Biopharmaceutical Industry in Ireland, 2020).

This course comprises one module from the MSc in Pharmaceutical Business Management.

Candidates seeking access to the Certificate in Quality and Regulatory Practice programme are required to hold either:
1. A Level 8 Honours Degree, 2.2H or higher, in Pharmacy, Science, Business or equivalent discipline.

2. A level 8 Honours Degree, 2.2H or Higher, in a non-business related discipline, with the following conditions:
- Candidates with significant business/management experience may apply through our APEL route, in line with college policy.
- Candidates who have no management experience will be assessed as to their prior learning. Where appropriate, candidates will be directed to take an additional module during semester one: Finance for Non-Financial Managers.

3. A level 8 Honours Degree, 2.2H or higher, in a business related non-STEM discipline, with the following conditions:
- Candidates with significant pharmaceutical experience may apply through our APEL route, in line with college policy.
- Candidates who have no pharmaceutical experience but who hold a business-related degree will be assessed as to their prior learning. Where appropriate, candidates will be directed to take an additional module during semester one: Introduction to Pharmaceutical Industry. This module is intended to prepare learners from general business backgrounds for the pharmaceutical learning outcomes during this MSc programme.

Applicants over the age of 23 may apply on the basis of previous work experience and a demonstration of commitment to further studies (Applicants under the age of 23 are required to meet the minimum entry requirements).

Each candidate's application will be considered individually in accordance with the College's QQI approved quality assurance procedures.

Candidates holding relevant alternative qualifications and those with related experiential learning will be considered under the College's RPL policy.

English Language
All learners are also expected to be proficient in the use of the English language. Where a candidate's mother tongue is not English, he/she will be required to provide proof of proficiency in the English language through satisfactory performance on an internationally recognised test (e.g. TOEFL 575, IELTS 6.5 or other similar English language qualifications).

Griffith College is accepting the online Duolingo English Test (DET) as valid proof of English proficiency.

How To Apply
Students who wish to apply for this course may apply directly to Griffith College. They should have obtained a degree at least a level 8 honours degree in pharmacy, science, business or related discipline.

When our Admissions team receive your application they will be in contact with you directly.

1 Semester Blended Learning.

Students who complete this course may proceed onto another Pharmaceutical Business Management course at Griffith College, including
• MSc in Pharmaceutical Business Management
• Postgraduate Diploma in Pharmaceutical Business Management

The skillset needed to work in a modern biopharma plant is evolving with the growing importance of biologics products.

These skills are highlighted in Ireland's National Skills Strategy 2025, where regulatory compliance and pharma co-vigilance roles are in demand by the industry.

Progression from this programme could include (depending on prior experience):
• Clinical - Regulatory Associate
• CMC (Chemistry, Manufacturing, and Controls) Regulatory Associate
• Regulatory Affairs Specialist