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Abdeckung

Termine

 

06.12.2021, 09:00-06.12.2021, 17:00

Good Clinical Clinical Practice (GCP)

Basic Training (English)
Good Clinical Practice (GCP) is the ethical and scientific basis for the planning, preparation, conduct and reporting of clinical trials. GCP defines the principles for any clinical trial conducted with medicinal products. GCP has been introduced by ICH (International Council on Harmonization) in 1997 and has just recently been revised.
The seminar will include presentations with many practical examples as well as workshops on the most important topics of GCP. The trainer will focus on the responsibilities of the study sponsor (e.g. pharmaceutical or biotech company) but will also cover those elements that are of importance for the investigational team at the study site, i.e. at the hospital or private practice.

Topics 
History and development of GCP; differentiation between clinical trial and non-interventional study; responsibilities of study sponsors including risk-based approach, quality management (quality assurance and quality control); responsibilities of the investigator in practical terms; submission to ethics committees and competent authorities; preparation, conduct, and reporting of a clinical trial with medicinal products.

Duration 
The qualification will comprise a total of 7,5 lessons which will be held from 9:00 a.m. to 05:00 p.m.

Size
The course will be held with a minimum of 6 and a maximum of 16 attendees. Due to organizational reasons, early registration is recommended.

Target Audience
The course is directed

  • to staff from pharmaceutical or biotech companies starting or planning to start clinical development programs having no or little experience with the current GCP requirements,
  • to natural scientists, PhD students and Postdocs of natural scientific and medical degree programs who are interested in getting an overview on GCP.

Learning Goals
After course completion, attendees will have developed a basic understanding of GCP requirements for the planning, preparation, and conduct of clinical trials with medicinal products. Thus, based on their individual background, attendees should also be able to identify potential occupational fields in the industry dealing with GCP topics.
Successful participation will be certified by the Gläsernes Labor Akademie (GLA).

Course fees
406,00 € per participant incl. VAT. 

Private registrees will get a fee reduction of about 10%.
According to local law (§ 11 Berliner Bildungsurlaubsgesetzes BiUrlG) the course can be classed as educational leave. 

Further information
Dr. Uwe Lohmeier per E-Mail: u.lohmeier@campusberlinbuch.de

Picture credits: ©motorolka/Shotshop.com

Version 16 December 2020
Subject to modifications

Veranstaltungsort:

Gläsernes Labor, Haus A13

Gläsernes Labor Akademie

31.08.2022, 09:00-03.09.2022, 18:00

From Target to Market - The GLA Biotech & Pharma Summer School

The 4-day intensive course provides a comprehensive overview of the entire drug development process in biotechnology and in the pharmaceutical industry – from the idea to the market.

The trainer team consists of experts in medicine, pharmaceutical industry, biotech companies, contract research and consulting organizations etc.

Since the course modules illustrate the drug development step by step, during the lectures and workshops attendees will become familiar with the complete process and will learn what the pharma industry and authorities are like.

Due to the compact, complete and competent course in a familiar atmosphere you will be able to
- apply the lecture contents during interactive and case-related exercises within small learning groups coached by the trainers
- get a deep insight into the process of drug development and build up contacts to industry experts
- discuss your questions with the trainers  

Course Language: English

Documentation: Attendees receive comprehensive paper documentationat the beginning of the course. The binders include print-outs of all presentation slides and working sheets as used during the workshop sessions. All paper documents, links to further information and literature will also be made available electronically through a course sharepoint.

Duration: The course will be held from Wednesday, 31 August 2022 to Saturday, 3 September 2022, daily from 9:00 a.m. till 06.00 p.m. plus evening lectures and events.

Size: The course is limited to a maximum of 12 participants and will only take place with a minimum of 6 participants. Due to organizational reasons, early registration is recommended.

Target Audience: The course is directed to natural scientists, PhD students and postdocs of natural scientific and medical degree programs who work in fundamental research, biotechnology or in research pharma companies with little or no experience in drug development.

Learning Goals: After course completion, attendees will have a basic understanding of the entire drug development process in the pharmaceutical industry and in biotechnology. Thus, based on their individual background, they should be able to identify potential occupational fields in the industry and authorities dealing with drug development and drug approvals.

Certification: The participation of the course will be certified by the German Life Science Association VBIO “Verband Biologie, Biowissenschaften und Biomedizin” and the Gläsernes Labor Akademie (GLA).

Course fees: 1.908,00 € per participant incl. 19% VAT, course binders and catering according to to program as attached. Participants of academical institutions pay 1.525,00 € incl. 19% VAT.
Assosciations which are members of the VBIO as well as  private applicants will get a fee reduction of 10%.

According to local law (§ 11 Berliner Bildungsurlaubsgesetzes BiUrlG) the course can be classed as educational leave.  

Further information
Dr. Uwe Lohmeier, Head GLA

u.lohmeier@campusberlinbuch.de

Veranstaltungsort:

Gläsernes Labor

From Target to Market - The GLA Biotech & Pharma Summer School