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

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Germany (1) - Malaysia (1) - Ukraine (1) - United Kingdom (31) - United States (5) - ALL COUNTRIES (39)

1
Precision Lung Cancer summit
25 Jul 2017 - 26 Jul 2017 • Boston, United States
Abstract:
Neo Synth presents the Annual Precision: Lung Cancer World Summit taking place on July 25-26 2017 in Boston, USA. Over the two days, this exclusive summit will bring together will bring together senior scientists and business leaders from pharma, biotech and academia, using extensive networking sessions to forge meaningful collaborations.
Contact:
Grace Hamilton;     Phone: [6175005172];     Email: grace@neo-synth.com
Topics:
oncology, immunotherapies, lung cancer
Event listing ID:
912817
Related subject(s):
2
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
10 Aug 2017 - 11 Aug 2017 • San Francisco, United States
Abstract:
Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA GMP workshop, FDA GMP Expectations, Phase I, First-in-Man Clinical Trials, CMC Requirements, IND Study, Raw Material Management
Event listing ID:
916118
3
FDA 510(k) Submissions — 510(k) Submissions to the FDA: Hands-On Workshop
24 Aug 2017 - 25 Aug 2017 • Chicago, United States
Abstract:
Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. This hands-on workshop will walk the attendees through the structure and key elements of the 510(k) submission and explains in clear language the most common pitfalls to avoid in the development of your 510(k) submission to the FDA.
Contact:
Peter Brown;     Phone: [410-501-5777];     Email: pbrown@fdamap.com
Topics:
FDA 510(k) Seminar, 510(k) submission, FDA 510(k) Clearance, 510(k) Regulations, FDA 510(k) Workshop, 510(k) Application, 510(k) Strategy, , 510(k) Listing, , 510(k) Filing, 510(k) Approval, Class 1 and 2 Medical Device
Event listing ID:
911447
4
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
24 Aug 2017 - 25 Aug 2017 • San Francisco, United States
Abstract:
The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
eCTD submission workshop, FDA eCTD submission training, CTD/eCTD format requirements, eCTD submission technical & document requirements
Event listing ID:
913973
5
6th International Conference on Clinical and Medical Case Reports
16 Oct 2017 - 18 Oct 2017 • San Francisco, United States
Abstract:
ICMCR 2017 cordially welcomes high quality late breaking abstract (case reports and clinical research) submissions in following specialties: Internal Medicine, Surgery and all sub specialties including Cardiovascular diseases, Gastrointestinal and Hepatic diseases, Respiratory disorders, Infectious diseases, Endocrine and metabolic disorders, Hematology, Musculoskeletal disorders, Allergy-Immunology, Oncology, Rare/Orphan diseases, Renal diseases, Rheumatology, Genetic disorders, Geriatrics, and Other.
Event listing ID:
911773

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