Bijdrage van Marcel Kenter

Register now! On March 4th, 2024 we will start with the next edition of the online course Market Approval. In this 5-week interactive learning-by-doing online course, you’ll learn how to identify the relevant regulatory guidelines that will steer you through the development process using our free Market Approval Navigator tool. This course uses real-world case studies such as the development of a gene therapy product, an antibiotic and also a fictitious mRNA-based vaccine to familiarize you with common issues that can arise during product development, and you’ll learn how to assess an IMPD (Investigational Medicinal Product Dossier) using the relevant guidelines and how to set up a Target Product Profile (TPP). The course includes our educational documentary The Rise, Fall and Return of Thalidomide, with several important take home messages for current drug developers. Contributions are from spiros vamvakas (Head Scientific Advice, European Medicines Agency), Murray Lumpkin (former Director CDER, FDA), Onno van de Stolpe (former CEO Galapagos), Jerry Zeldis (former CMO Celgene), Eline Bunnik (Erasmus MC), Henk Schuring (former Vice President Head Rare Neurological Disease, Genzyme ), Bert Leufkens (former Chairman College ter Beoordeling van Geneesmiddelen), Sjaak Bot (former Vice President Regulatory Affairs, The Janssen Pharmaceutical Companies of Johnson & Johnson), mentor Ineke Jonker-Hoogerkamp and more. For more information, free demo and brochure go to https://lnkd.in/eMhGYn8h #professionaldevelopment #onlineeducation #onlinelearning #lifelonglearning #marketapproval #fda #EMA #regulatoryaffairs #pharma #biotech #medtech

Register now! On March 4th, 2024 we will start with the next edition of the online course Clinical Development. In this 5-week interactive learning-by-doing online course, you’ll learn the meaning, limitations and impact of different types of value calculations for product development projects such as the (risk-adjusted) Net Present Value (NPV) and the Question-Based Clinical Development (QBCD) methodology (see De Visser et al., Nature Biotechnology Jan. 2020). The course includes our Netflix-like series QUESTIONS! demonstrating in 6 episodes how the QBCD methodology can be applied to define the optimal developmental route for your product. Contributions are from Hans-Georg Eichler (European Medicines Agency EMA), Rick Kuntz (former CMO/CSO Medtronic), Inge De Lepeleire (Merck), mentor Saco de Visser (Future Affordable Sustainable Therapies) and others. For more information, free demo and brochure go to https://lnkd.in/gnvrFQd #clinicaldevelopment #npv #drugdevelopment #medicaldevice #pharma #biotech #medtech #lifelonglearning #professionaldevelopment #onlinelearning

On March 4, 2024, we will launch a new edition of our learning-by-doing online Intellectual Property course for postgraduate biomedical and pharmaceutical professionals, business developers and Tech Transfer Office (TTO) employees. The course contains various animations and infographics, teaching cases, exercises based on R&D projects of biotech, pharmaceutical and medtech companies, and self-assessments. Tools are available to help you estimate the costs of obtaining and maintaining a patent or drawing up a draft licensing agreement. The course has been updated to cover the new European Unified Patent procedures and the Unitary Patent Court (UPC). Contributions are from Aliki Nichogiannopoulou (European Patent Office), Onno van der Stolpe (formed CEO Galapagos), Maurits Westerik (Coupry), Marc Martens (Bird & Bird), Karin Verzijden (Axon Laywers), Bart Swinkels (NLO | European patent and trademark attorneys) and others. The course contains interactive video calls with mentor Bruno Vandermeulen. For more info and brochure go to https://lnkd.in/eJxR37S  #intellectualproperty #IP #patent #UnifiedPatent #UnitaryPatentCourt #UPC #EPO #license #professionallearning #onlinelearning #biotech #pharma #medtech

Register now! On March 4th, 2024 we will start with the next edition of the online course Clinical Development. In this 5-week interactive learning-by-doing online course, you’ll learn the meaning, limitations and impact of different types of value calculations for product development projects such as the (risk-adjusted) Net Present Value (NPV) and the Question-Based Clinical Development (QBCD) methodology (see De Visser et al., Nature Biotechnology Jan. 2020). The course includes our Netflix-like series QUESTIONS! demonstrating in 6 episodes how the QBCD methodology can be applied to define the optimal developmental route for your product. Contributions are from Hans-Georg Eichler (EMA), Rick Kuntz (former CMO/CSO Medtronic), Inge De Lepeleire (MSD), mentor Saco de Visser  and others. For more information, free demo and brochure go to https://lnkd.in/gnvrFQd #clinicaldevelopment #npv #drugdevelopment #medicaldevice #pharma #biotech #medtech #lifelonglearning #professionaldevelopment #onlinelearning

On March 4, 2024, we will launch a new edition of our learning-by-doing online Intellectual Property course for postgraduate biomedical and pharmaceutical professionals, business developers and Tech Transfer Office (TTO) employees. The course contains various animations and infographics, teaching cases, exercises based on R&D projects of biotech, pharmaceutical and medtech companies, and self-assessments. Tools are available to help you estimate the costs of obtaining and maintaining a patent or drawing up a draft licensing agreement. The course has been updated to cover the new European Unified Patent procedures and the Unitary Patent Court (UPC). Contributions are from Aliki Nichogiannopoulou (European Patent Office), Onno van der Stolpe (formed CEO Galapagos, Maurits Westerik (Coupry), Marc Martens (Bird&Bird), Karin Verzijden (Axon Laywers), Bart Swinkels (NLO) and others. The course contains interactive video calls with mentor Bruno Vandermeulen. For more info and brochure go to https://lnkd.in/eCXJVZt   #intellectualproperty #IP #patent #UnifiedPatent #UnitaryPatentCourt #UPC #EPO #license #professionallearning #onlinelearning #biotech #pharma #medtech

On March 4, 2024, we will launch a new edition of our learning-by-doing online Intellectual Property course for postgraduate biomedical and pharmaceutical professionals, business developers and Tech Transfer Office (TTO) employees. The course contains various animations and infographics, teaching cases, exercises based on R&D projects of biotech, pharmaceutical and medtech companies, and self-assessments. Tools are available to help you estimate the costs of obtaining and maintaining a patent or drawing up a draft licensing agreement. The course has been updated to cover the new European Unified Patent procedures and the Unitary Patent Court (UPC). Contributions are from Aliki Nichogiannopoulou (European Patent Office), Onno van der Stolpe (formed CEO Galapagos, Maurits Westerik (Coupry), Marc Martens (Bird&Bird), Karin Verzijden (Axon Laywers), Bart Swinkels(NLO) and others. The course contains interactive video calls with mentor Bruno Vandermeulen. For more info and brochure go to https://lnkd.in/eCXJVZt hashtag #intellectualproperty #IP #patent #UnifiedPatent #UnitaryPatentCourt #UPC #EPO #license #professionallearning #onlinelearning #biotech #pharma #medtech

Last chance to register for our online Intellectual Property course starts October 30th, 2023. The course is now updated to cover the new European Unified Patent procedures and Unitary Patent Court, and the recent US Supreme Court ruling on the Amgen vs Sanofi / Regeneron case that will have major implications for companies and universities who are developing antibodies. Contributions are from Aliki Nichogiannopoulou (European Patent Office), Bart Swinkels (partner at NLO | European patent and trademark attorneys), Onno van de Stolpe (former CEO Galapagos, Marc Martens, Maurits Westerik (partner at Coupry), Karin Verzijden (partner at Axon Laywers), Ton van den Hoven (former CEO SurgVision GmbH), mentor Bruno Vandermeulen and others. For more information, free demo and brochure go to https://lnkd.in/eJxR37S #propertylaw #IP #intellectualproperty #patent #license #pharma #biotech #antibodies #medtech #onlinelearning #professionaldevelopment #UnifiedPatent #UnitaryPatentCourt #UPC

The next edition of our online Intellectual Property course starts October 30th, 2023. Read below the testimony of Charlotte Berendsen (former senior associate, research program management Genmab, now project manager Healthy Living TNO). The course is now updated to cover the new European Unified Patent procedures and Unitary Patent Court, and the recent US Supreme Court ruling on the Amgen vs Sanofi / Regeneron Regeneron case that will have major implications for companies and universities who are developing antibodies. Contributions are from Aliki Nichogiannopoulou (European Patent Office), Bart Swinkels (partner at NLO | European patent and trademark attorneys), Onno van de Stolpe (former CEO Galapagos), Marc Martens (partner at Bird & Bird), Maurits Westerik (partner at Coupry), Karin Verzijden (partner at Axon Laywers), Ton van den Hoven (former CEO SurgVision GmbH), mentor Bruno Vandermeulen and others. For more information, free demo and brochure go to https://lnkd.in/eJxR37S #propertylaw #IP #intellectualproperty #patent #license #pharma #biotech #antibodies #medtech #onlinelearning #professionaldevelopment #UnifiedPatent #UnitaryPatentCourt #UPC

The next edition of our online course Market Approval for post-graduate pharmaceutical and biomedical professionals, researchers and regulatory affairs staff starts October 30th, 2023. Read below the testimony of alumnus Anna van Muyden, Director Clinical Development at CellPoint, a Galapagos company. Contributions are from spiros vamvakas (Head Scientific Advice, EMA), Murray Lumpkin (former Director CDER, FDA), Onno van de Stolpe (former CEO Galapagos), Jerry Zeldis (former CMO Celgene), Eline Bunnik (Erasmus MC), Henk Schuring (former Vice President Head Rare Neurological Disease, Genzyme), Bert Leufkens (former Chairman MEB-CBG), Sjaak Bot (former Vice President Regulatory Affairs, Janssen), mentor Ineke Jonker-Hoogerkamp and others. For brochure, free demo, more information and registration go to: https://lnkd.in/eMhGYn8h #lifelonglearning #professionallearning #onlinelearning #MarketApproval #EMA #FDA #lifesciences #medicinalproducts