UCC CPD courses

Biopharmaceutical Development of Investigational Medicinal Products

About

Fact File

  • Title

    Biopharmaceutical Development of Investigational Medicinal Products

  • Code

    PF6204

  • College

    Medicine and Health

  • Duration

    To be confirmed

  • Teaching Mode

    Part-Time. See Additional Teaching Mode Information for more info.

  • Fees

    €2000 See Fees and Costs for full details.

  • Entry Requirements

    See Requirements for full details.

  • Closing Date

    Now Closed for Application 2018-19

  • Venue

    Exact rooms to be confirmed within the College of Medicine and Health.

  • Credits

    5

  • Start Date

    11.01.19

Outline

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

  • Explain the impact of physicochemical properties, the dosage form/formulation and route of administration on the biological response of the drug,
  • Provide experience in calculating the primary pharmacokinetic parameters of a drug,
  • Understand the importance of biopharmaceutical assessment of drugs in the context of lead selection, formulation development, bioavailability assessment and bioequivalence,
  • Understand the regulatory framework for the development of investigational medicinal products.

Module Objective: To understand the effects of formulation on in vivo performance of medicinal products. To explain how new drugs are developed from the initial screening in-vitro to the types of pivotal clinical studies normally undertaken in order to achieve licensing.

Module Content: Introduction to Biopharmaceutics and Pharmacokinetics: Principles of drug absorption, dististribution, metabolism and excretion. Impact of dosage form and route of administration on drug pharmacokinetics, Influence of formulation and physiochemical properties on bioavailability, Assessment of biopharmaceutical properties, Assessment of pharmacokinetic properties, In vitro in vivo correlations
Drug Development and licensing of IMPs: Pharmaceutical Profiling in drug discovery and Lead selection; Drug product development, pre-formulation studies and scale-up; Clinical Trial design and IMP legislation; Principles of Good Clinical Practice (GCP); Marketing Authorisation Applications; Scale up and Post Approval changes; Bioequivalence and generic applications; Biowaivers and Biopharmaceutical Drug Classification Scheme

Additional Teaching Mode Information

Teaching Method(s): 35hr(s) Directed Study (Distance learning); 1 x 2hr(s) Lectures; 1 x 2hr(s) Workshops; Workshops.

 

Practicalities

The module incorporates printed module workbooks, teleconferences, web-based seminars and online assessments.  The module runs for approximately four weeks.  The average amount of directed study that you are advised to undertake per module is about 10-15 hours per week.  The module consists of continuous assessment elements and a written exam.  The written exam takes place in April.

Assessment: Total Marks 100: Formal Written Examination 80 marks; Continuous Assessment 20 marks (written assignments and in-term tests).

Compulsory Elements: Formal Written Examination; Continuous Assessment.

Requirements

All candidates must be approved by the programme committee within the School of Pharmacy. Applicants may be short listed for interview.
A candidate must have obtained at least a Second Class Honours primary degree in a relevant science discipline (NFQ level 8) which has been approved by the programme committee (e.g. pharmacy, chemistry or the biological sciences);

Candidates must be currently employed in a relevant pharmaceutical sector (ideally greater than two years experience) and for the duration of the programme;

Consideration may be given to other applicants with suitable equivalent professional qualifications and significant industrial experience (greater than 5 years relevant experience in the industry).

If you are applying with Qualifications obtained outside Ireland and you wish to verify if you meet the minimum academic and English language requirements for this programme please view the grades comparison table by country and for details of recognised English language tests. 

Fees and Costs

The fee for this module in 2018-19 is €2000.  There is also a €35 application fee to be paid on submitting your application.

How Do I Apply

Contact details

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