Conférences - Législation en médecine et pharmacologie

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1
GMP Phase I — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
24 oct 2019 - 25 oct 2019 • Boston, États-Unis
Résumé:
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.
Contact:
Tél.: [+410 501 5777];     Email.: pkumar@fdamap.com
Identifiant de l'évènement:
1256524
2
PV — 20th Pharmacovigilance 2019
07 nov 2019 • Mumbia, Inde
Résumé:
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.
Contact:
Tél.: [+91 44 24762472];     Email.: kavitha@virtueinsight.co.in
Sujets:
Pharmacovigilance, DrugSafety, ProductSafety, DrugDevelopment, ClinicalSafety, patientsafety, RiskManagement, regulatoryaffairs
Identifiant de l'évènement:
1268656
3
Technical Writing — Technical and Regulatory Writing for FDA-Regulated Industry
14 nov 2019 - 15 nov 2019 • Boston, États-Unis
Résumé:
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.
Contact:
Tél.: [+410 501 5777];     Email.: pkumar@fdamap.com
Identifiant de l'évènement:
1256567
4
Living Materials 2020
12 fév 2020 - 14 fév 2020 • Saarbrücken, Allemagne
Organisateur:
INM - Leibniz Institute for New Materials
Résumé:
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.
Contact:
Conference office;     Email.: livmat2020@leibniz-inm.de
Sujets:
living materials, controlled drug delivery, active implants, medical materials, living therapeutics,
Identifiant de l'évènement:
1276542
5
PSW20 — 3rd Annual Pharma Security World 2020 “Supply-Chain, Drug Serialization and Anti-Counterfeiting” Conference and Expo
25 mar 2020 - 26 mar 2020 • Londres, Royaume-Uni
Résumé:
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.
Contact:
Tél.: [02070960786];     Email.: info@corvusglobalevents.com
Sujets:
PharmaSecurityWorld, counterfeitdrugs, Anticounterfeiting, BrandProtection, drugsecuritySerialization, Traceability, SupplyChain, IP, PharmaSupplyChain, Packaging, BrandEnforcement, BrandIntegrity, Labelling, Printing, TrackAndTrace, DrugRegulatory, RFID, fakedrugs
Identifiant de l'évènement:
1247554
6
TM 2020 — 2020 International Conference and Exhibition on Traditional & Alternative Medicine
26 mar 2020 - 27 mar 2020 • Madrid, Espagne
Organisateur:
Research Lake International
Résumé:
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.
Contact:
Tél.: [+1 (647) 551-8989];     Email.: kate.john.0295@gmail.com
Sujets:
Medicine Conference Topics: Traditional, Alternative, Herbal, Ayurveda, Chinese, Japanese, Arabic, Unani, Homeopathic, Pharmacognosy and medicine for cancer.
Identifiant de l'évènement:
1271793
7
2nd Drug Delivery Conference
20 jul 2020 - 23 jul 2020 • Lisbonne, Portugal
Résumé:
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.
Contact:
Conference Manager;     Tél.: [00441638724137];     Email.: admin@fusion-conferences.com
Sujets:
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
Identifiant de l'évènement:
1279381


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Dernière mise à jour: 08 Octobre 2019