direkt zum Inhalt springen
Abdeckung

Termine

 

07.06.2021, 09:00-08.06.2021, 13:00

Protecting your Innovation - Workshop on Intellectual Property and Regulatory Exclusivity in Biotech & Pharma

Advanced One-Day Course (English)

When, how and for how long can I protect and monetize my biotech or pharma innovation? Being able to answer these questions is crucial whenever a Biotech or Pharma company decides to discover their products to the public and to the market - therefore we have set up this new workshop with two modules:

  1. Intellectual Property: Patents, Supplementary Protection Certificates (SPCs) and Litigation 
  2. Regulatory Exclusivity and Reimbursement 

Topics
Module 1: Intellectual Property

  • Patents: Process of filing and granting patents in Europe and the world
  • Patentable subject-matter in the field of medicine: Overview and second medical use (new medical purpose)
  • Digression: Patenting of medical devices with “double function”
  • Supplementary Protection Certificates (SPCs): Definition and explanation, case law, comparison to other legislation, future of SPCs
  • Patent litigation: Enforcement - case law;  “Skinny labelling” - consequences for healthcare system and health insurance
  •  Practical Exercise 1: “Skinny labelling”

Module 2: Regulatory Exclusivity and Reimbursement

  • Regulatory exclusivity in Europe and other countries: Overview, regulatory exclusivity, market access, research exclusivity, paediatric medicines exclusivity in the EU, manufacturing waiver
  • Digression: Biosimilars
  • Reimbursement and pricing negotiations with health insurance (AMNOG in force since 2011 with smaller amendments in 2013 and 2014): Benefit assessment of medicinal products, AMNOG process (result, risk, comparison to other countries)
  •  Practical Exercise 2: Reimbursement and pricing negotiations with health insurance (DE)

Prerequisites
Some experience in the field of intellectual property protection in the context of the biotech and pharma industry is required. For example, attendance to the GLA Biotech & Pharma Summer School. Since the workshop will focus on the specificities and challenges of this sector, the attendee should be at least partially familiar with the following general concepts of intellectual property protection: 
- Basics of intellectual property protection (incentivising innovation by granting time-limited monopoly, invention has to be novel, inventive and enabled)
- Life cycle of a patent (from drafting to infringement lawsuit): Pre–grant, i.e. strategy, research and application, further actions such as opposition, appeal, invalidity/nullity, infringement, licensing, cooperation

Duration 
2-Half-Day Workshop. The qualification will comprise a total of 7,0 lessons. 

Size
The course will be held with a minimum of six and with a maximum of 16 attendees. 
Please note that an early registration is recommended since the number of places available is limited and the demand might exceed availability. 

Registration Deadline
09 May 2021

Target Audience
The course is directed to staff from pharmaceutical or biotech companies who are bringing or planning to bring their products to the market, as well as life science researchers who are generally interested in the interplay between IP and regulatory approaches.

Learning Goals
After course completion, attendees will have developed a good understanding of  intellectual property and regulatory concepts at the complex interface between these fields. The attendees will be able to define the exclusivity period of a pharmaceutical product in light of patent rights, supplementary protection certificates (SPCs), litigation outcomes and regulatory considerations. A further learning goal is to convey a basic understanding of reimbursement mechanisms in Germany including negotiation strategies with public health insurance in the context of regulatory and scientific requirements. The successful participation will be certified by the Gläsernes Labor Akademie (GLA).

Course fees
522,00 € per participant incl. VAT.
Private registrees will get a fee reduction of about 10%.
According to local law (§ 11 Berliner Bildungsurlaubsgesetz BiUrlG) educational leave applies. 

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

Version: 26 Feb 2021
Subject to modifications 

Veranstaltungsort:

Online Course with Zoom.

Gläsernes Labor Akademie

08.11.2021, 09:00-19.11.2021, 18:00

Weiterbildungskurs: Fachkraft für Molekularbiologie (TÜV)

Das 11-tägige Intensiv-Seminar vermittelt Grundlagenwissen zu den wichtigsten Labormethoden der modernen Molekularbiologie und vermittelt Einblicke in die klinische Forschung. Nutzen Sie auch die Gelegenheit um von den Tipps und Tricks der Wissenschaftler*innen aus der Forschungspraxis zu profitieren.

Nach Abschluss der Veranstaltung erhalten Sie eine Teilnahmebescheinigung vom Gläsernen Labor. Die Prüfung für den Erwerb des TÜV Zertifikats besteht aus einem schriftlichen (single choice) Test und einem mündlichen Teil.

Für den Kurs kann nach § 11 des Berliner Bildungsurlaubsgesetzes (BiUrlG) Bildungsurlaub geltend gemacht werden. 

 

Inhalte Intensivkurs:

Molekularbiologische Methoden: Grundlagen, Sequenzierung, Isolierung, Reinigung, Trennung und Visualisierung von Nukleinsäuren, Klonieren von rekombinanter DNA, PCR, CRISPR/Cas9 Genome Engineering
- Proteinanalytische Methoden: Grundlagen, Immunologische und immunchemische Methoden, Methoden der Proteinanalyse (Massenspektrometriebasierte Proteomik, Grundlagen der proteomischen Datenanalyse u.a.)
- Biologische Datenbanken: Grundlagen, praktische Übungen im Internet, DNA Sequenzvergleiche
- Epigenetik und Genomics: Genregulation mittels Epigenetik, DNA- und Proteinchips
- Zellbiologische Techniken: Einführung in die Zellkultur, Stammzellen
- Klinische Forschung: Molekulare Ursachen von Krankheiten, Molekulare Ursachen von Tumorerkrankungen, Individualisierte Medizin, Pharmakogenetik

Dauer:
Der Intensivkurs umfasst 88 Unterrichtsstunden und findet als Blockkurs vom 08.11.2021 bis zum 19.11.2021 statt, außer Sonntag, 14.11.2021, täglich von 9:00 Uhr bis 18:00 Uhr inkl. Pausen. Bitte entnehmen Sie den genauen Kursplan der PDF Datei beim Termin.

Gruppenstärke:
Maximal 12 Teilnehmer*innen. Der Kurs wird erst ab Erreichen der Mindestteilnehmerzahl von 5 durchgeführt.

Zielgruppe:
Technische Angestellte und Laboranten*innen mit abgeschlossener Berufsausbildung sowie Mitarbeiter*innen aus biologisch-biowissenschaftlichen Einrichtungen mit Labor-Erfahrungen.

Kursgebühr:
1.722,00 € je Teilnehmer/in inkl. 19% MwSt. Prüfungsgebühr: 348,00 € je Teilnehmer/in inkl. MwSt.
Für Selbstzahlende wird ein Rabatt von 10% auf die Kursgebühr gewährt.

Nach § 11 des Berliner Bildungsurlaubsgesetzes (BiUrlG) kann für den Kurs Bildungsurlaub geltend gemacht werden.
Bitte beachten Sie weitere Informationen unter: https://www.glaesernes-labor-akademie.de/de/service

 Geplanter Prüfungstermin für die TÜV Prüfung: Voraussichtlich Freitag, 03.12.2021

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

PDF: Kursplan-Molbio

Gläsernes Labor Akademie

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