we pave the way for biotechs

Termine

07.12.2020, 09:00 bis 07.12.2020, 17:00

GOOD 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 was just recently revised.
The seminar will include presentations with a lot of 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. till 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, an 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 being 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.
The successful participation will be certified by the Gläsernes Labor Akademie (GLA).

Course fees
416,50 € per participant incl. VAT (350,00 EUR excl. VAT). 

Private registrees will get a fee reduction of about 10%.
According to local law (§ 11 Berliner Bildungsurlaubsgesetzes BiUrlG) educational leave applies. 

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

Picture credits: ©motorolka/Shotshop.com

Gläsernes Labor Akademie

09.12.2020, 16:00 bis 09.12.2020, 18:00

SARS-Cov-2-Forschung: Zellveränderungen bei Infektion und daraus entstehende unterschiedliche Krankheitsverläufe

Aufgrund der aktuellen Bestimmungen zur Eindämmung der Corona-Pandemie wurde der Termin vom 9. Novmber auf den 9. Dezember verschoben.

SARS-Cov-2-Forschung: Zellveränderungen bei Infektion und daraus entstehende unterschiedliche Krankheitsverläufe
Dr. Emanuel Wyler, Max-Delbrück-Centrum für Molekulare Medizin in der Helmholtz-Gemeinschaft (MDC)/BIMSB

Das Virus SARS-Cov-2 beschäftigt derzeit die ganze Welt und beeinflusst unseren Alltag. Auch in Berlin läuft die Forschung auf Hochtouren. Der MDC-Wissenschaftler Dr. Emanuel Wyler untersucht die Veränderungen in verschiedenen Zellen und Organoiden bei einer Infektion. Hierbei wird die Frage geklärt: Welche Veränderungen finden in infizierten Zellen statt und wie entstehen daraus schwere oder milde Krankheitsverläufe? Die Veränderungen in einer infizierten Zelle können von Zelltyp zu Zelltyp unterschiedlich sein. Die untersuchten Modelle sind bspw. Lungenstücke, verschiedene Organoide und unterschiedliche Zelllinien. 

Neuer Termin: 9. Dezember 2020, 16:00 bis 17:30 Uhr

Anmeldung: https://lamapoll.de/LTL

Für Lehrkräfte, Schülerinnen und Schüler sowie Interessierte

Ort: Digitale Veranstaltung

Gläsernes Labor

14.09.2021, 09:00 bis 22.09.2021, 18:00

GMP Biotech Summer School

Good Manufacturing Practice (GMP) Basic Course Biotechnology (English)

Knowing and applying the Good Manufacturing Practice (GMP) regulations is one of the key elements in the manufacture of medicinal products for clinical trials and on industrial level. 

This Course concentrates on GMP requirements regarding biopharmaceutical and Advanced Therapy Medicinal Products (ATMP) manufacturing.

During the Course the most important elements of GMP will be explained in an easy-to-understand way with reference to the relevant GMP regulations and examples how regulatory requirements are transferred into practice.

The Course will include some workshop elements where trainees together with the trainer develop GMP compliant solutions (e.g. risk assessments, equipment qualification).

According to local law (§ 11 Berliner Bildungsurlaubsgesetzes BiUrlG) educational leave applies.  

Topics:

History and Evolution of GMP; Regulatory Authorities (EU, US, Germany), GMP Regulations/ Guidance (Global, EU, US, Germany); Quality Systems; Documentation; Personnel; Premises; Equipment; ; Production: Basics; Production-Biologics: Up-stream, Down-stream, Fill&Finish; Production-ATMPs: Up-stream, Down-stream, Fill&Finish; Process Validation; Quality Control; Validation of Analytical Procedures; Inspections and Audits; Outsourced Activities; Investigational Medicinal Products; Clinical Trials; Licence Application; Computerized Systems; Data Integrity.

Duration:
The qualification will comprise a total of 80 lessons which will be held from Tuesday, 14 September 2021 to Wednesday, 22 September 2021, daily from 9:00 a.m. till 06.00 p.m., excl. Sunday, 19 September 2021. Please note, Saturday, 18 September 2021 is a regular course day.

Size:
The course is limited to a maximum of 20 participants and will only take place with a minimum of 5 attendees. Due to organizational reasons, an early registration is recommended.

Target Audience:
The Course is directed to staff (Natural scientists, PhD students and postdocs of natural scientific and medical degree programs; Technical assistants and trained laboratory assistants with professional experience) having no or little experience with the current GMP requirements.

Learning Goals:
After course completion, attendees will have a thorough understanding of GMP basics as needed for the manufacturing of Biopharmaceuticals and ATMPs. Thus, based on their individual background, they should be able to identify potential occupational fields in the industry and authorities dealing with GMP topics. 

The successful participation will be certified by the German Pharmaceutical Industry Association (BPI) and by the Gläsernes Labor Akademie (GLA).

Prerequisites:
Laboratory experiences are advisable.

Course fees: 
2.315,00 € per participant incl. 19% VAT.

Private registrees will get a fee reduction of about 10 %.

Further information:

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

GMP Biotech Summer School

MDC
FMP
Charite
Campus Berlin-Buch
Berlin Buch