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5. PF6042: Contract and External Manufacturing in Pharma and Biopharma

Course Fact File

Code	PF6042
Duration	12 weeks
Teaching Mode	Part-Time. See Additional Teaching Mode Information for more info.
NFQ Level	Level 9
Fees	€2,500 - HCI Subsidy Initiative See Fees and Costs for full details.
Closing Date	Currently closed for applications
Venue	Blended delivery.
Credits	10
Start Date	Currently closed for applications

Outline

Module Goal

To provide students with a holistic introduction to contract/external manufacturing, development and testing in pharma/biopharma industry and to develop the transversal skills required to perform in this area of biopharma/pharma industry

Module Content

• Customer relationship management
• Project Management
• Alliance management
• Quality and Regulatory issues in contract/external manufacturing and testing
• Supply chain considerations in CMO
• CDMO/CTO Selection process
• Influencing, Negotiation and Communication skills

Additional Teaching Mode Information

• 1x 7 hr(s) workshops
• 12 x 1 hr(s) lectures
• 2 x 1 hr(s) tutorials

30 hr(s) directed learning

Practicalities

Continuous Assessment - 200 marks

• In-class test (MCQ) - 2 in class MCQs (80 marks)
• Presentation (120 marks)

Why Choose

On successful completion of this module, students should be able to:

1. Analyse and evaluate the decision to outsource development, manufacturing or testing of (bio)pharmaceuticals

2. Detail the additional quality and regulatory requirements in contract manufacturing/testing

3. Develop, improve sustain strong customer relationships, alliances and partnerships in a CDMO/External Manufacturing environment

4. Demonstrate strong influencing and negotiation skills

Requirements

Applicants must have at least

• Second Class Honours Grade 2 in a primary honours’ degree (NFQ, Level 8) in any of the following relevant subject areas: chemistry, biology, biochemistry, physiology, pharmacy, pharmaceutical sciences or science, healthcare science, technology, or process engineering. Eligible applicants may also be invited for an interview.
  • Selection from among eligible applicants will be made according to the following criteria: 
    • Performance in their primary degree
    • Personal statement
    • Consideration under Recognition of Prior Learning (RPL) may also be given to applicants who do not meet the above entry requirements but who have relevant professional experience in a suitable field. To demonstrate relevant professional experience, applicants will be assessed on the following criteria and an interview may also be required. 
      1. Academic achievement
      2. Relevant industry experience
      3. Personal statement
      4. Reference

Fees and Costs

The HCI Pillar 3 Micro-credential Learner Fee Subsidy has been introduced to enable more learners to address critical skills gaps and engage with lifelong learning.

The fee for this micro-credential is €2,500 but applicants who meet the subsidy requirements can attend this micro-credential for €1250.

Check your eligibility on the HEA Website

How To Apply

Currently closed for applications