Meetings/Workshops on Translational Medicine, Clinical Trials in the United States (USA)

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Austria (2) - France (1) - United Kingdom (2) - United States (4) - ALL COUNTRIES (9)

1
2019 ASENT Annual Meeting — 2019 American Society for Experimental Neurotherapeutics (ASENT) Annual Meeting
25 Mar 2019 - 28 Mar 2019 • Rockville, United States
Abstract:
The ASENT Annual Meeting provides the latest in basic science and clinical development, and features sessions on emerging therapies in Parkinson’s Disease and Movement Disorders, Pain, Multiple Sclerosis, Epilepsy and Neurodegenerative Disorders. Technological breakthroughs featured include the use of deep brain stimulation, spinal cord stimulation, genomic-based drug discovery, the growing emphasis on new drug delivery systems.
Contact:
Email: jessica@asent.org
Topics:
Neurology, Neuroscience, Drug Development, Clinical Trials, Pharmecuticals, Biotechnology, Conference
Event listing ID:
1129899
Related subject(s):
Event website:
2
FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
09 May 2019 - 10 May 2019 • Boston, United States
Abstract:
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:
Phone: [+410 501 5777];     Email: pkumar@fdamap.com
Event listing ID:
1196605
3
Clinical Project Management Training — One Day Online Training in Clinical Project Management
20 May 2019 • Washington DC, United States
Abstract:
Clinical trials are highly regulated multi-dimensional projects that require constant interactions between the regulators and the sponsors, investigators, other personnel, and even patients involved in the conduct of a given trial. There are many diverse tasks involved in the conduct of a clinical trial starting from the development of a clinical trial protocol, finding and starting clinical trial sites, filing of an IND or IDE application, approvals from IRBs, numerous documents need to be collected to demonstrate compliance with regulations; managing supplies, collecting data, writing reports, and many other things. Clinical project managers need to understand, implement, and trouble-shoot practically all aspects of the clinical trial under them. Clinical project managers have to build teams and have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. This one-of-a-kind program will train you in regulatory affairs, clinical operations, monitoring, patient recruitment and retention, planning, medical writing, safety monitoring and practically all major aspects of running a clinical trial.
Contact:
Phone: [+410 501 5777];     Email: pkumar@fdamap.com
Event listing ID:
1196603
4
iPharma2019 — 2nd International Pharmaceutical Conference and Expo
05 Jun 2019 - 07 Jun 2019 • Baltimore, United States
Abstract:
2nd International Pharmaceutical Conference and Expo welcomes you as our guest to the City of Baltimore, USA during June 05-07, 2019. iPharma 2019 includes nearly every permutation of knowledge, innovation, technology and networking; and has an objective of creating an international forum for academicians, practitioners and business professionals to discuss the soundest issues related to Pharma, Biotech and Health Care.
Contact:
Email: jia@ipharmaconference.com
Topics:
Drug Discovery and Development, Pharmacovigilance and Drug Safety, Novel Drug Delivery Systems and Drug therapy, Pharmaceutical Nanotechnology, Drug Regulatory Affairs, Pharmacology, Neuropharmacology, Nutraceuticals, Pharma Marketing, Orphan and Rare Disease and more.
Event listing ID:
1091549
Related subject(s):

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Last updated: 12 February 2019