Meetings/Workshops on Clinical trials in the United States (USA)

Submit a meeting

Select a location:
Austria (1) - Germany (2) - India (1) - Netherlands (1) - Singapore (2) - Spain (1) - Switzerland (2) - United Kingdom (5) - United States (6) - ALL COUNTRIES (21)

1
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
03 May 2018 - 04 May 2018 • Tampa Marriott Westshore, FL, United States
Abstract:
Review the FDA recommendations and requirements for implementing a compliant program for the phase 1 clinical program.
Event listing ID:
1046902
2
CTL — Clinical Trial Innovation Summit 2018
07 May 2018 - 09 May 2018 • Boston, United States
Abstract:
New Technologies, Analytics, Quality Measures and Improved Partnerships for Clinical Trials of the Future: Cambridge Healthtech Institute's Clinical Trial Innovation Summit brings together 250 leaders from across pharma, biotech and academia for the perfect blend of high quality presentations and intimate networking. Through case studies, interactive discussions and an active exhibit hall, the summit delivers the real-world experiences and best practices needed to optimize clinical trial management. Presentations span across the most complex areas of trial management, including patient recruitment, site selection, data integration, leveraging existing data sources, mobile technologies, project management, outsourcing, vendor management, budgeting and contracting, quality (QbD) in trial conduct and risk-based monitoring.
Contact:
Cambridge Healthtech Institute;     Phone: [781.972.5400];     Email: chi@healthtech.com
Topics:
technologies, analytics, quality measures, improved partnerships, clinical trials, life sciences, biotech, biotechnology, pharma
Event listing ID:
1015909
Related subject(s):
3
FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
10 May 2018 - 11 May 2018 • 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:
Peter Brown;     Phone: [410-501-5777];     Email: pbrown@fdamap.com
Topics:
FDA GMP Regulations, GMP Guidance, Good Manufacturing Practices, GMP, GMP Phase 1, Clinical Trials, Investigational New Drug, Process Validation, New Drug Development
Event listing ID:
1032067
4
Gordon Research Seminar — Drug Safety
09 Jun 2018 - 10 Jun 2018 • Stonehill College, Easton, MA, United States
Topics:
Drug Safety in the Modern Development Landscape: Innovations from Industry, Academia, and Government
Event listing ID:
960099
5
Gordon Research Conference — Drug Safety
10 Jun 2018 - 15 Jun 2018 • Stonehill College, Easton, MA, United States
Topics:
Contemporary Advances and Challenges in Drug Safety Assessment
Event listing ID:
960067
6
CVCT 2018 — 15th GLOBAL CARDIOVASCULAR CLINICAL TRIALISTS FORUM
29 Nov 2018 - 01 Dec 2018 • Washington D.C., United States
Abstract:
The meeting encourages knowledge-sharing between participants as CVCT aims to familiarize practitioners and investigators with the science of clinical trials from protocol design to result interpretation. Further, CVCT Forum puts attendees into direct contact with primary investigators, senior trial scientists as well as research and development experts from pharmaceutical/device companies and experts from regulatory agencies.
Contact:
CVCT TEAM;     Phone: [+33 1 40 88 97 97];     Email: cvct@overcome.fr
Topics:
CVCT, cardiovascular, surgery, heart failure, ATHEROSCLEROSIS, renal endpoints, diabete, biomarkers
Event listing ID:
1015849
Related subject(s):

View all listed conferences in the United States (USA).



Conference-Service.com offers, as part of its business activities, a directory of upcoming scientific and technical meetings. The calendar is published for the convenience of conference participants and we strive to support conference organisers who need to publish their upcoming events. Although great care is being taken to ensure the correctness of all entries, we cannot accept any liability that may arise from the presence, absence or incorrectness of any particular information on this website. Always check with the meeting organiser before making arrangements to participate in an event!

ComplianceOnline - Clinical Trial
AIP Conference Proceedings
AIP Publishing -  Author Services
Last updated: 04 April 2018