Tagungen und Workshops zum Thema Legislation in der Medizin und Pharmakologie

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ALLE LÄNDER (9)
1
GMP Phase I — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
24. Okt 2019 - 25. Okt 2019 • Boston, Vereinigte Staaten
Zusammenfassung:
Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements. The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.
Kontakt:
Tel.: [+410 501 5777];     Email: pkumar@fdamap.com
Eintrags-ID:
1256502
2
PV — 20th Pharmacovigilance 2019
07. Nov 2019 • Mumbia, Indien
Zusammenfassung:
20th Pharmacovigilance 2019 Conference provides the strongest context, background, updates, new developments, and future direction for regulations and guidance on safety, pharmacovigilance, and risk management strategies that cannot be found in any other meeting. The content of this event is developed by top experts from the biopharmaceutical industry and global regulatory agencies, and Virtue Insight will convene the best speakers from around the world to discuss the current challenges and issues that matter most to professionals working in the field.
Kontakt:
Tel.: [+91 44 24762472];     Email: kavitha@virtueinsight.co.in
Themen:
Pharmacovigilance, DrugSafety, ProductSafety, DrugDevelopment, ClinicalSafety, patientsafety, RiskManagement, regulatoryaffairs
Eintrags-ID:
1268689
3
Technical Writing — Technical and Regulatory Writing for FDA-Regulated Industry
14. Nov 2019 - 15. Nov 2019 • Boston, Vereinigte Staaten
Zusammenfassung:
Regulatory professionals have to write highly technical documents for a variety of audience. These documents include reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and communication documents. This workshop will address best practices, and regulatory strategies on how to write effective documents covering anywhere from simple issues such as minutes of meetings and correspondence notes, to highly sophisticated nonclinical and clinical study reports, and regulatory submissions to FDA, EMA, Health Canada, and other regulators.
Kontakt:
Tel.: [+410 501 5777];     Email: pkumar@fdamap.com
Eintrags-ID:
1256512
4
VIbsc — 14th Biosimilars Congregation 2019
12. Dez 2019 • Mumbai, Indien
Veranstalter:
Virtue Insight
Zusammenfassung:
14th Biosimilars Congregation 2019 will be your opportunity with leading industry experts to discuss from development, manufacturing to commercialization - The current landscape, legal, regulatory, funding, challenges, market access strategy, business models and how to get to market.
Kontakt:
Tel.: [+91 44 24762472];     Email: kavitha@virtueinsight.co.in
Themen:
Biopharmaceuticals, Biotherapeutics, Follow on Biologics, Follow on Proteins, Biologics, Biotechnology, Biogenerics, Legal Affairs, Intellectual Property
Eintrags-ID:
1281246
Verwandte Fachgebiete:
5
Living Materials 2020
12. Feb 2020 - 14. Feb 2020 • Saarbrücken, Deutschland
Veranstalter:
INM - Leibniz Institute for New Materials
Zusammenfassung:
A new paradigm in material synthesis is emerging, in which living cells are used as active components in man-made materials to augment non-living matter with life-like capabilities. “Living Materials” promise to change the way we design technological and medical devices, and open infinite possibilities for programmable functions. Self-ventilating sportswear, bio-syncretic robots, self-renewing bioremediation devices, biosensing tattoos, personalized drug delivery systems or self-healing concrete walls are just a few examples. This conference will provide an open forum for sharing recent advances and discussing current challenges and potential of Living Materials among experts and newcomers in the field. It will gather leading scientists and industrial partners, and tackle fundamental science and application-oriented approaches.
Kontakt:
Conference office;     Email: livmat2020@leibniz-inm.de
Themen:
living materials, controlled drug delivery, active implants, medical materials, living therapeutics,
Eintrags-ID:
1276586
6
3D Cell Culture — SMi's 4th Annual 3D Cell Culture Conference
19. Feb 2020 - 20. Feb 2020 • London, Großbritannien
Veranstalter:
SMi Group
Zusammenfassung:
SMi’s 3D Cell Culture Conference will explore advances of organ and lab-on-a-chip, microphysiological systems, applications of technology and case studies, imaging, high throughput screening and advances in 3D cell culture models which make up core components within the 3D Cell Culture field. For the first time ever the NEW 3D Bioprinting Focus Day on 18 February 2020 will explore case studies from big pharma, biotech’s and academia exploring how bioprinting is being used in industry highlighting projects looking at stem cell therapy, drug screening and extracellular matrix scaffolds.
Kontakt:
Tel.: [02078276000];     Email: ssapal@smi-online.co.uk
Themen:
Organ-on-chips, microfluidics, cell culture, 3D cell culture, 3D bioprinting, bioprinting, organoid, extracellular matrix, ECM, tissue engineering, physiochemical factors, cell-based assay, cytotoxicity, cell metabolic pathways, cancer research, molecular diagnostics, cell and gene therapy, microphysiological, co-culture systems complex in-vitro models, high throughput screening, 3D imaging, drug screening, extracellular matrix scaffolds, 3D drug development, regenerative therapies
Eintrags-ID:
1281339
7
PSW20 — 3rd Annual Pharma Security World 2020 “Supply-Chain, Drug Serialization and Anti-Counterfeiting” Conference and Expo
25. Mär 2020 - 26. Mär 2020 • London, Großbritannien
Zusammenfassung:
The rising tide of counterfeit medicines are turning into a serious concern around the world, and have progressively been showing up through the real pharmaceutical supply chain, including community and online drug stores.Counterfeit drugs are not only a global public health risk, but also harm the quality of the product, the integrity of the brand, the economy and even national security.We require both countrywide and industry-level participation, and in addition public and private sector coordinated effort, to identify and definitively battle counterfeiters.
Kontakt:
Tel.: [02070960786];     Email: info@corvusglobalevents.com
Themen:
PharmaSecurityWorld, counterfeitdrugs, Anticounterfeiting, BrandProtection, drugsecuritySerialization, Traceability, SupplyChain, IP, PharmaSupplyChain, Packaging, BrandEnforcement, BrandIntegrity, Labelling, Printing, TrackAndTrace, DrugRegulatory, RFID, fakedrugs
Eintrags-ID:
1247532
8
TM 2020 — 2020 International Conference and Exhibition on Traditional & Alternative Medicine
26. Mär 2020 - 27. Mär 2020 • Madrid, Spanien
Veranstalter:
Research Lake International
Zusammenfassung:
2020 International Conference and Exhibition on Traditional & Alternative Medicine during March 26-27 2020, Madrid, Spain. Traditional Medicine 2020 aims to gather leading traditional physicians’ educational scientists, researchers and research students to exchange & share their experiences and research results about all aspects of Traditional and Alternative medicine. Traditional Medicine 2020 includes prompt keynote presentations, oral talks, poster presentations and exhibitions, workshop, Symposium. We gladly welcome attendees from all around the world to present their ideas, expand their networks, knowledge, and recent innovations and inventions in the field of Traditional & Alternative Medicine.
Kontakt:
Tel.: [+1 (647) 551-8989];     Email: kate.john.0295@gmail.com
Themen:
Medicine Conference Topics: Traditional, Alternative, Herbal, Ayurveda, Chinese, Japanese, Arabic, Unani, Homeopathic, Pharmacognosy and medicine for cancer.
Eintrags-ID:
1271837
9
2nd Drug Delivery Conference
20. Jul 2020 - 23. Jul 2020 • Lissabon, Portugal
Zusammenfassung:
This conference focuses on the design, synthesis and clinical validation of new drug delivery vehicles. This conference is designed to bridge the gap between basic science and unmet clinical needs.
Kontakt:
Conference Manager;     Tel.: [00441638724137];     Email: admin@fusion-conferences.com
Themen:
Therapeutic gene editing, Extrahepatic delivery of nucleic acids, Characterization of therapeutic nanoparticles and control strategies for manufacturing, New linkers for triggered or controlled release, New long acting technologies, Tumor targeting with nanoparticles, recent progress and challenges
Eintrags-ID:
1279392


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Stand vom 16. Oktober 2019