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M.Sc./Postgraduate Diploma in Pharmaceutical Manufacturing Technology (Online)

Planning a career as a Qualified Person or in Pharmaceutical Quality Management?

This course is offered to graduates working in the pharmaceutical industry, who may wish to satisfy the EU educational requirements for the role of the Qualified Person (QP) responsible for the manufacture of human and veterinary medicinal products.

Over 500 students have successfully completed the course, many of these now hold global or senior executive quality management positions in pharmaceutical multinational companies. Recent international graduates include those from Australia, California, UK, and Singapore.

The newly digitised course has been developed in collaboration with industry experts and the regulatory authority to meet the requirements of the industry today. The course has been desigend to provide flexibility for students, who are working in supervisory and management roles in the pharmaceutical industry, to manage the challenge of balancing work/study/family responsibilities.

Entry Requirements

These are determined so that on successful completion of the MSc/Postgraduate Diploma the minimum conditions of qualification for QP status are achieved (EC Directives 2001/83/EC and 2001/82/EC):

• Applicants are expected to have an Honours Bachelor degree ideally 2.1 or above extending over 3 or 4 years in one of the following disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology; other disciplines may also be considered as suitable.
• Applicants are expected to have some experience of working in the pharmaceutical manufacturing and associated industries.

Acceptability of the course

Diplomates of the course are recognised by EU regulatory authorities as satisfying the educational requirements in respect of the academic training necessary for registration as a Qualified Person. Successful completion of the course does not guarantee recognition as a Qualified Person, as the granting of such status is the responsibility of the Pharmaceutical Regulatory Authority, The Health Products Regulatory Authority (HPRA) in Ireland. They reserve the right to accept or reject any candidate for registration according to their judgment of a candidate’s suitability and industrial experience.

The Course

The course is a two year online course running from January to December each year, comprising of eight taught modules - see Course Structure below. Throughout the year participants are required to attend either in person or virtually a number of manufacturing facility visits, module tutorials, workshops, regulatory lectures, networking events and examinations. Each module contains several sessions. Tutorials are synchronous and largely occur at weekly or two weekly intervals. Details regarding tutorials will be released at the beginning of each module.

Course Structure (Modules)

To achieve the Postgraduate Diploma, students will complete eight taught modules, totalling 60 ECTS. These modules are:

·      Pharmaceutical Processing
·      Pharmacology and Drug Assessment
·      Pharmaceutical Chemistry
·      Pharmaceutical Dosage Forms
·      Pharmaceutical Biology
·      Innovation and Leadership in Health Product Manufacturing
·      Health Product Analysis and Testing
·      Regulation of Health Products and Manufacturing

Candidates who are eligible and wish to progress to the M.Sc. must complete a QP Professional Industrial dissertation [30ECTS].

Application Procedure

Application for this course should be made online through the Graduate Studies website: www.tcd.ie/courses/postgraduate/how-to-apply. Please email your CV to the office (dippmt@tcd.ie) at the same time as applying online. We will then be able to assist with your application. Should you have any queries or difficulties, please call or e-mail the office and we will do our best to resolve any issues (contact details below).
Note: For this course, employer/company references replace the requirement for academic references. Applicants should therefore inform their referee that a general reference is required, including the suitability of the applicant for the qualification. This may be done on the academic reference form which is automatically e-mailed to nominated referees or referees may prefer to write a letter of reference and upload it instead.

Fees

11,120 per year

Contact details

Further information may be obtained by contacting:

	Academic Director Dr Bernard Naughton	email bernard.naughton@tcd.ie		Course Co-ordinator Lorna Loughrey	email LOUGHRLA@tcd.ie phone 353-1-896 2812
	Course Administrator Louise Griffin	email DIPPMT@tcd.ie phone 353-1-896 2811		Research Assistant Eleni Niarchou	email eniarcho@tcd.ie