Termine

13.06.2024, 17:00-13.06.2024, 19:00

Talk im Cube: Building the bridge from preclinical to clinical studies

The transition from preclinical studies to human clinical trials is challenging in many ways – scientifically, regulatory and organizationally. Companies need to become even more efficient to get their drugs through the development process.

Panel Discussion:
Building the bridge from preclinical to clinical studies
Proven experts in the field of preclinical and clinical development will introduce into the complexity of the topic and will discuss how to streamline the processes and to minimize risks and pitfalls.

With

Jens Hoffmann, Managing Director of Experimental Pharmacology & Oncology (EPO), Berlin-Buch GmbH,
Michael Firgens, Managing Director at MF Biotech, Berlin,
Virgilio Garcia Lerma, Executive Director, Regulatory Strategy at Worldwide Clinical Trials, Madrid, Spain,
Uwe Lohmeier, Head of Gläsernes Labor Akademie (GLA), Campus Berlin-Buch GmbH (Moderation)

Key Topics:

• Reflect clinical problems in preclinical models,
• Balance in vitro, animal and human experimentation from an ethical point of view,
• Comply with regulatory requirements such as ICH, EMA, FDA etc.,
• Remain financially successful.

Don’t miss the opportunity to join in the discussion and exchange ideas with each other and our experts over snacks and drinks at the subsequent get-together and networking
event.

BerlinBioCube, Campus Berlin-Buch, Robert-Rössle-Str. 10, 13125 Berlin

Registration is requested.

10.09.2024, 09:00-13.09.2024, 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.

Size: The course is limited to a maximum of 16 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: 1.850,00 € per participant plus VAT, course binders and catering according to to program as attached. Participants of academical institutions pay 1.480,00 € plus 19% VAT. Assosciations which are members of the VBIO as well as  private applicants will get a fee reduction of 10%.

Further information 
Dr. Uwe Lohmeier, Head GLA

u.lohmeier@campusberlinbuch.de

Version 07 Nov 2023
Subject to modifications

Campus Berlin-Buch

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

08.10.2024, 09:00-17.10.2024, 18:00

GMP Biotech Summer School

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 face-to-face 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 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.

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 Tuesday, 08 October 2024 to Thursday, 17 October 2024, daily from 9:00 a.m. till 06.00 p.m., excl. Saturday, 12 October & Sunday, 13 October 2024. 

Size:
The course is limited to a maximum of 16 participants and will only take place with a minimum of 6 participants. Due to organizational reasons, an early registration is recommended.

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: 
2.250,00 € per participant plus 19% VAT.
Private applicants will get a fee reduction of about 10 %.

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

Picture credits: Marc Voigt, Immutep GmbH

Version:   07 Nov 2023 
Subject to modifications

Campus Berlin-Buch

GMP Biotech Summer School