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CEMDC, Semmelweis University

BIOLOGICAL MEDICINAL PRODUCTS AND ADVANCED THERAPIES

Practical Information

Commencing Date:
February 07-10, 2019
Language:
English
Location:
Budapest Hungary


Teaching Methodology:
Face-to-Face
Duration:
4 days
Credits :
ECTS


European Fees:
1000 EUR for students participating only at selected modules
Scholarship Possibilities:
No

Course Contact

Ms. Judit Lendvay, Course Manager; Dr. Sandor Kerpel-Fronius, Course Director

+36304757366

cemdc3@gmail.com


Website

CEMDC, Semmelweis University

University Accreditation: Yes

Centre of Excellence

Description

The students will receive an update on molecular biology and immunology needed for understanding the development of biological and advanced medicinal products as well as vaccines. The development, application, and regulatory requirements of these medicinal products will be discussed in detail. 

Outcomes

1. Demonstrate an understanding of the scientific, regulatory, ethical and legal issues that are peculiar to biological and advanced therapies.

2. Demonstrate an understanding of the challenges presented in constructing a package of  non-clinical data to support the clinical development and marketing of biological and advanced therapies.

3. Recommend a clinical trial plan that is appropriate for the different types of products and technologies represented by biological and advanced therapies.

4. Demonstrate an understanding of the technical and manufacturing issues that are peculiar to biological and advanced therapies.

5. Critically review the non-clinical and clinical scientific knowledge underlying the development  of new or prospective biological or advanced therapies.

6. Describe the new technologies now available and those in development; describe the therapeutic opportunities that might arise from the technology.

7. Critically analyse the differences between natural and modified protein constructs.

8. Describe the global need for new and improved vaccines and the barriers to their development.

9. Discuss the history and future prospects for gene therapy, and the technical difficulties developing a gene therapy product.

10. Describe the concept of stem cell therapy, what opportunities it might present, and the ethical    issues that are unique to this technology.

11. Describe the particular ethical and regulatory issues of advanced therapies and how The Advanced Therapy Directive is addressing these.

12. Demonstrate the understanding of the basic principles of the development of medical devices. Assess the scientific and regulatory issues relevant to the clinical development of medical device-drug combinations. 

 

Covered Areas

Scientific Areas

Medicines development 

Therapeutic Areas

-

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered