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CEMDC, Semmelweis University

FOLLOW-ON DRUGS: GENERIC, BIOSIMILAR & NON-BIOLOGICAL

Practical Information

Commencing Date:
May 16-19, 2019
Language:
English
Location:
Budapest Hungary


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


European Fees:
1000 EUR for students who wish to participate only at select
Scholarship Possibilities:
No

Course Contact

Study Manager: Ms. Judit Lendvay, Mob: +36304757366; Email: cemdc3@gmail.com; Dr. Sandor Kerpel-Fronius, Course Director

_+36304757366

cemdc3@gmail.com


Website

CEMDC, Semmelweis University

University Accreditation: Yes

Centre of Excellence

Description

The lecturers will discuss the development, regulations, and marketing of various types of follow-on drugs: generic, biosimilar and non-biological similar medicinal products.  It will be a unique experience to overview this very rapidly developing field and to understand how do these types of drugs modify the marketing policy of medicinal products. 

Outcomes

1. Compare the scientific and regulatory basis for the definitions of the various types of follow-on drugs: generic, biosimilar and non-biological similar medicinal products, define their significance in the life-cycle management of medicines.

2. Choose the right timing of pharmacokinetic studies during follow-on drug development.  

3. Assess the appropriate in vitro and in vivo methods to establish equivalent bioavailability of generic drugs. 

4. Analyze the diversity caused by the development of independent formulations for the same active ingredients by the follow-on producer.

5. Comprehend and appreciate the causes leading to the diversity of the biosimilar medicinal products manufactured by different producers.

6. Appreciate the complex non-clinical and clinical comparative study requirements needed to evaluate the biological and immunogenic properties of biosimilar medicinal products including biosimilar monoclonal antibodies

7. Appreciate the specific properties of different complex non-biological similar medicinal products

8. Analyze, comprehend and assess the complexity and international diversity of regulatory requirements for evaluating the efficacy and  safety of follow-on non-biological similar products

9. Evaluate the public health significance of follow-on drugs on the market. Comprehend the differences in the pricing principles of follow-on generic, biosimilar and non-biological medicinal products 

10. Assess the clinical pharmacological problems associated with reference pricing

11. Appraise the various clinical pharmacological issues related to the clinical interchangeability of generic, biosimilar and non-biological similar products drugs.

12. Appraise the international significance of quality assurance of follow-on products. 

13. Assess the international medical significance of counterfeiting drug.

14. Appreciate the factors influencing the adoption of follow-on drugs in the everyday practice.  

 

Covered Areas

Scientific Areas

Pharmaceutical medicine. Medicines development, regulation and marketing of drugs.

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