PRE-CLINICAL REGULATORY AND QUALITY COMPLIANCE ISSUES WORLD-WIDE

Enrique Barrajon, Vicente Micol Molina, Guest Lecturers (24 h - 3 ECTS)

Theory: 12 h

Laboratory: 12h

Title Pre-clinical regulatory and quality compliance issues world-wide (3 ECTS)
Program

 

1.   Cosmetic regulatory affairs. Registration and labelling.

Enrique Barrajón + guest lecturers

1  theoretical (2 hours) and 1 practical (3 hours) sessions.

2.   Preclinical regulatory affairs.

Enrique Barrajón + guest lecturers

1  theoretical (2 hours) and 1 practical (3 hours) sessions.

3.   Good manufacturing practices in cosmetic industry.

Enrique Barrajón

1  theoretical (2 hours) session.

4.   Qualification and validation in cosmetic industry.

Guest lecturers

1  theoretical (2 hours) and 1 practical (2 hours) sessions.

5.   Quality and compliance.

Enrique Barrajón + guest lecturers

1  theoretical (2 hours) and 1 practical (2 hours) sessions.

6.   Cosmoceuticals and nutricosmetics.

Enrique Barrajón + Vicente Micol

1  theoretical (2 hours) and 1 practical (2 hours) sessions.

 

Sources –  Regulatory documents obtained from national and international regulatory agencies worldwide.

–  ISO/UNE documents.

–  Aulton’s Pharmaceutics. The design and manufacture of medicines. Editorial: Churchill Livingstone Elsevier.

 

Objectives and expected results 1.     Acquire a basic acknowledge about drug and cosmetic regulatory affairs, with special interest in registering and labeling.

1.1.  Students will learn how to handle and use the main legal documents worldwide.

1.2.  Students will develop skills to prepare required documents according legal requirements.

2.     Understand the studies that must be developed during the preclinical phase of a new product and learn how to select the right one on each case.

2.1.  Being able to prepare all the required documents using preclinical studies results.

3.     Understand the main aspects of Good Manufacturing Practices regulation, with special interest on qualification and validation procedures.

3.1.  Being able to design a Master Validation Plan.

4.     Learn the basic principles of quality and compliance in cosmetic industry.

4.1.  Handle the main documents used in quality and compliance management.

5.     Distinguish, understand and use the differences between drugs, cosmetics, nutricosmetics and cosmeceuticals products.

5.1.  Understand claims regulation for novel foods and products.

 

Prerequisites Although there are no specific prerequisites, soft skills as team working, writing scientific text and communicative ability will be welcome.
Teaching methods Theoretical sessions will be based on classic lectures but using interactive technologies and apps. Discussion between lecturers and students and journal club discussions will be also used to reinforce the main topics.

Practical sessions will be based on team and individual tasks. During these practical sessions, student will be asked to use internet resources and scientific databases to develop their exercises.

Exam modality 25% of the mark. During theoretical sessions, student will be asked to answer quiz and true/false questions using different apps.

50% of the mark. After each practical session, student will prepare the required documentation that will be graded according the given instructions.

25% of the mark. A final written exam evaluating the knowledge and notions acquired during the lectures and practical sessions); the test will consist of up to 4 open questions (answers of 100-150 words maximum) and 10-20 multiple choice questions (with one true answer).

TITLE

Pre-clinical regulatory and quality compliance issues world-wide (3 ECTS)

 

PROGRAM

  1. Cosmetic regulatory affairs. Registration and labelling.

Enrique Barrajón + guest lecturers

1  theoretical (2 hours) and 1 practical (3 hours) sessions.

  1. Preclinical regulatory affairs.

Enrique Barrajón + guest lecturers

1  theoretical (2 hours) and 1 practical (3 hours) sessions.

  1. Good manufacturing practices in cosmetic industry.

Enrique Barrajón

1  theoretical (2 hours) session.

  1. Qualification and validation in cosmetic industry.

Guest lecturers

1  theoretical (2 hours) and 1 practical (2 hours) sessions.

  1. Quality and compliance.

Enrique Barrajón + guest lecturers

1  theoretical (2 hours) and 1 practical (2 hours) sessions.

  1. Cosmoceuticals and nutricosmetics.

Enrique Barrajón + Vicente Micol

1  theoretical (2 hours) and 1 practical (2 hours) sessions.

SOURCES

  • Regulatory documents obtained from national and international regulatory agencies worldwide.
  • ISO/UNE documents.
  • Aulton’s Pharmaceutics. The design and manufacture of medicines. Editorial: Churchill Livingstone Elsevier.

OBJECTIVES AND EXPECTED RESULTS

  1. Acquire a basic acknowledge about drug and cosmetic regulatory affairs, with special interest in registering and labeling.
    • Students will learn how to handle and use the main legal documents worldwide.
    • Students will develop skills to prepare required documents according legal requirements.
  2. Understand the studies that must be developed during the preclinical phase of a new product and learn how to select the right one on each case.
    • Being able to prepare all the required documents using preclinical studies results.
  3. Understand the main aspects of Good Manufacturing Practices regulation, with special interest on qualification and validation procedures.
    • Being able to design a Master Validation Plan.
  4. Learn the basic principles of quality and compliance in cosmetic industry.
    • Handle the main documents used in quality and compliance management.
  5. Distinguish, understand and use the differences between drugs, cosmetics, nutricosmetics and cosmeceuticals products.
    • Understand claims regulation for novel foods and products.

PREREQUISITES

Although there are no specific prerequisites, soft skills as team working, writing scientific text and communicative ability will be welcome.

TEACHING METHODS

Theoretical sessions will be based on classic lectures but using interactive technologies and apps. Discussion between lecturers and students and journal club discussions will be also used to reinforce the main topics.

Practical sessions will be based on team and individual tasks. During these practical sessions, student will be asked to use internet resources and scientific databases to develop their exercises.

EXAM MODALITY

25% of the mark. During theoretical sessions, student will be asked to answer quiz and true/false questions using different apps.

50% of the mark. After each practical session, student will prepare the required documentation that will be graded according the given instructions.

25% of the mark. A final written exam evaluating the knowledge and notions acquired during the lectures and practical sessions); the test will consist of up to 4 open questions (answers of 100-150 words maximum) and 10-20 multiple choice questions (with one true answer).

Last modified: January 07, 2020