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13.02.2023, 09:00-22.02.2023, 18:00

GMP Biotech Winter School - Online

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

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 an industrial level. 

This online course based on Zoom 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 of how regulatory requirements are transferred into practice.

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

According to local law (Berliner Bildungszeitgesetz BiZeitG) the course can be classed as educational leave.  

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; License Application; Computerized Systems; Data Integrity.

Duration:
The qualification will comprise a total of 80 lessons which will be held from Monday, 13 February 2023 to Wednesday, 22 February 2023, daily from 9:00 a.m. till 06.00 p.m., excl. Saturday and Sunday.

Size:
The course is limited to a maximum of 15 participants and will only take place with a minimum of 5 participants. 

Target Audience:
The course is directed to natural scientists, PhD students and postdocs of natural scientific and medical degree programs, technical assistants and trained laboratory assistants with professional experience who have little or no 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. 

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: 
1.942,00 € per participant plus 19% VAT. Private applicants will get a fee reduction of about 10 %.

Registration Deadline: 16 January 2023

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

Location:

Online Course

Gläsernes Labor Akademie

20.03.2023, 09:00-20.03.2023, 17:00

Scientific Resource Management

THE BUSINESS OF MANAGING SCIENCE: SCIENTIFIC MANAGEMENT AND LEADERSHIP SKILLS

A one-day online workshop based on Zoom for scientists to enhance business management skills required for running shared resource laboratories, technology platforms and core facilities.

Leadership and management skills are critical for a successful career in science and beyond. Comprehension of these skills is required whether you are running your own lab group, a core facility or your own business. This course will bring together scientists who want to enhance their business management skills for running shared resource laboratories, technology platforms, and core-facilities. There will be tips and tricks throughout from experienced experts in the area. It is geared towards all levels, from those experienced in running a core lab to those looking to move in to and develop a career within core facilities/shared resource labs.

The course instructors are experienced science management leaders with proven skills in research infrastructure management. They will provide a dynamic recourse using their experiences in science and technology management, leadership, entrepreneurship and technology transfer. The ultimate goal is to provide participants with an experience that translates into developing their leadership and business management skills.

Duration
The qualification will comprise a total of 7,0 hours which will be held online based on Zoom.

Size 
The course will be held with a minimum of 10 and a maximum of 16 attendees. 

Registration deadline
20 February 2023

Target Topics and Audience
1. Lectures will discuss the challenges and solutions in the management of research projects, departments, shared resource laboratories, technology platforms, and core-facilities.
2. Interactive sessions will allow participants to explore entrepreneurship and develop a business or grant application plan.
3. Participants will have plenty of networking opportunities.

This course will be valuable for anyone (Masters/Ph.D students, postdocs, research scientists, principal investigators, professionals already in research infrastructure management roles, scientific entrepreneurs) who is interested in or currently in a position of leadership within scientific research and those interested in setting up their own business, e.g.
- Facility Managers
- PhD Students
- Postdoctoral Scientists
- Principal Investigators
- Lab Managers

Learning Goals  
1. Management: To understand how to develop and maintain research projects and infrastructures as a business enterprise
2. Entrepreneurship: To be able to build a business model (balancing non-profit ambition versus for-profit needs); and understand the balance between research service and research collaboration
3. Networking: To be able to network and form collaborations effectively as well as distinguishing opportunity from obligation
4. Mentorship: Course instructors will aim to establish lasting mentorship contacts with the participants
Successful participation will be certified by the Gläsernes Labor Akademie (GLA).

Course fee: 358,- € plus VAT 
Private registrees will get a fee reduction of about 10%.

According to local law (Berliner Bildungszeitgesetz BiZeitG) the course can be classed as educational leave. 

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

Picture by Pixabay

Location:

Online-Course

Scientific Resource Management

30.08.2023, 09:00-02.09.2023, 18:30

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.

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: 1.683,00 € per participant plus VAT, course binders and catering according to to program as attached. Participants of academical institutions pay 1.346,00 € plus 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 (Berliner Bildungszeitgesetz BiZeitG) the course can be classed as educational leave.  

Further information 
Dr. Uwe Lohmeier, Head GLA

u.lohmeier@campusberlinbuch.de

Location:

Campus Berlin-Buch, Robert-Rössle-Straße 10, 13125 Berlin

Gläsernes Labor Akademie