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Events

2020-08-13, 09:00 to 2020-08-21, 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 Thursday, 13 Aug 20 till Friday, 21 Aug 20, daily from 9:00 a.m. till 06.00 p.m., excl. Sunday, 16 Aug 20.

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: 
2.374,05 € per participant incl. 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

2020-09-02, 09:00 to 2020-09-05, 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 until to market.

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

Since course modules illustrate the drug development step by step, attendees will become familiar during lectures and workshops how the complete process works and what is the pharma industry and authorities 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 excercises 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 at the beginning of the course comprehensive paper documentation. 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 qualification will be held from Wednesday, 2 Sept 2020 till Saturday, 5 Sept 2020, 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 20 participants and will only take place with a minimum of 6 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) working in fundamental research, biotechnology or in researching pharma companies having no or little 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: 1.957,55 € per participant incl. VAT, course binders and catering according to program as attached. Attendees of academical institutions pay 1.564,85 € incl. VAT.
Assosciations being member of the VBIO as well as  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, Head GLA , u.lohmeier@campusberlinbuch.de

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

MDC
FMP
Charite
Campus Berlin-Buch
Berlin Buch