Meetings/Workshops on Regulation in Medicine and Pharmacology in Germany

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Belgium (2) - Germany (6) - India (1) - United Arab Emirates (1) - United Kingdom (3) - United States (17) - ALL COUNTRIES (30)

1
CfPIE - The Center for Professional Innovation & Education — CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars
23 May 2018 - 25 May 2018 • Berlin, Germany
Abstract:
This course will help the attendee to develop a CMC regulatory compliance strategy for biopharmaceuticals, biosimilars and other biologics, addressing the five core elements that comprise an effective strategy: (1) embracing the full spectrum of CMC activities, (2) addressing unique requirements for specific biologic manufacturing processes, (3) addressing unique requirements for specific biologic products, (4) aligning with the strategic ICH Q8/Q9/Q10 guidances, and (5) applying a clinical phase-appropriate approach. The critical importance of communicating CMC regulatory compliance strategy with the regulatory authorities at CMC-focused meetings will be stressed. In addition, this course will also help the attendee to better understand the CMC regulatory compliance requirements for Quality by Design applications and for biosimilars.
Contact:
Olivia Carlin;     Phone: [1-610-648-7550];     Email: info@cfpie.com
Topics:
compliance, biologics, FDA, EMA, regulatory review pathways, IND, NDA, BLA, MAA
Event listing ID:
1009996
Related subject(s):
2
CfPIE - The Center for Professional Innovation & Education — Preparing the CMC Section for MAAs, IMPDs
30 May 2018 - 31 May 2018 • Berlin, Germany
Abstract:
This course includes an overview of the relevant guidelines and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of MAAs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, manufacturing and pharmaceutical development. It will also discuss the use of Drug Master Files (DMF), Certificates of Suitability (CEPs) and preparation of the CTD Quality Overall Summary (Module 2).
Contact:
Olivia Carlin;     Phone: [1-610-648-7550];     Email: info@cfpie.com
Topics:
MAA, CTD, drug substance, purity, stability, DMF, Certificates of Suitability, CEP, CMC, chemistry manufacturing and controls
Event listing ID:
1010067
Related subject(s):
3
2nd HBP Curriculum Workshop Series - ENTREPRENEURSHIP IN NEUROSCIENCE - TURNING SCIENCE INTO INVENTION & INNOVATION
04 Jul 2018 - 06 Jul 2018 • Berlin, Germany
Abstract:
This "hackathon" style workshop is a hands-on intensive experience complementing the theoretical aspects of the online course on Intellectual Property Rights, Translation and Exploitation of Research. Students will work in small multi-disciplinary teams to assemble joint applied research proposals in the wide range of fields in brain science. Experienced entrepreneurs, top executives at the interface between academia and industry and researchers from academia will present, mentor and advise on the translational aspects of the offered projects including how to advance their proposal from the lab to market, understand the problems and accordingly defining the needs in the chosen field, choosing or identifying the target population, patentability options and how to build a business model. Finally, they will present their proposals to industry and academy experts. The workshop is a unique experience of diving into the entrepreneurial world, learning how to incorporate innovation and entrepreneurship mindset and concepts into day-to-day research work and beyond.
Contact:
HBP Education Programme Office;     Email: curriculum.edu@humanbrainproject.eu
Topics:
Hackathon, entrepreneurship, invention, innovation, industry, research, academia, blue ocean strategy, product-market, interactive patents, data protection
Event listing ID:
1034571
4
2nd HBP Curriculum Workshop Series - RESEARCH, ETHICS AND SOCIETAL IMPACT DUAL USE AND RESPONSIBLE RESEARCH. ETHICAL CHALLENGES
04 Jul 2018 - 06 Jul 2018 • Berlin, Germany
Abstract:
This workshop aims to provide participants with insights on ethical aspects of dual-use research in neuroscience and Responsible Research and Innovation (RRI). Lectures will be given by some of the world's leading experts on dual-use in neuroscience research, and by active researchers on RRI. The topics covered will include the chemistry of the brain and dual action of drugs, novel incapacitants, ethics awareness and engagement and RRI. An important ingredient of the workshop is the use of team-based learning techniques.
Contact:
HBP Education Programme Office;     Email: curriculum.edu@humanbrainproject.eu
Topics:
Ethical aspects, dual-use, neuroscience, Responsible Research and Innovation, chemistry of the brain, dual action of drugs, novel incapacitant, ethics awareness, team-based learning
Event listing ID:
1034592
5
Course — European Regulatory Procedures - EMA & National Requirements
13 Sep 2018 - 14 Sep 2018 • Berlin, Germany
Abstract:
This course will give participants the necessary overview of the application procedures and regulatory filing pathways used within Europe to grant marketing authorisations for medicinal products, and of the agencies and institutions that control the regulatory process. Special focus will be given to the European Medicines Agency (EMA) and the Centralised Procedure (CP), with the role of the national health authorities and other EU bodies in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) explained also. Factors affecting the choice of procedure will be discussed, as well as best practice in the management of the procedures. A workshop session will engage participants in a case study evaluating the options for submission of a marketing authorization application.
Contact:
Olivia Carlin;     Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
European Regulatory Procedures, Regulation, EMA, Centralised Procedure, European Medicines Agency, Filing Strategy, Labeling
Event listing ID:
1012340
Related subject(s):
6
Course — Filing Variations in the European Union
07 Nov 2018 - 08 Nov 2018 • Berlin, Germany
Abstract:
The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections.
Contact:
Olivia Carlin;     Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
filing, extensions, Marketing Authorizations, filing variations, CMD, Submission, Timeline
Event listing ID:
1012517

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Last updated: 20 March 2018