Meetings/Workshops on Regulation in Medicine and Pharmacology in the United States (USA)

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1
ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
23 Sep 2019 - 25 Sep 2019 • Washington, D.C., United States
Organizer:
American Statistical Association
Event listing ID:
1145536
2
Pharmacovigilance — 19th Pharmacovigilance 2019
08 Oct 2019 - 10 Oct 2019 • Boston, United States
Abstract:
will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.
Contact:
Phone: [+44 2036120886];     Email: kavitha@virtueinsight.co.in
Topics:
Pharmacovigilance, DrugSafety, ProductSafety, DrugDevelopment, ClinicalSafety, patientsafety, RiskManagement, regulatoryaffairs
Event listing ID:
1247506
Related subject(s):
3
FDA SOPs Training — FDA Compliant SOPs for Regulated Industry: How to Create High Quality SOPs that Your Team and FDA Auditors Will Love
10 Oct 2019 - 11 Oct 2019 • Boston, United States
Abstract:
SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.
Contact:
Phone: [+410 501 5777];     Email: pkumar@fdamap.com
Event listing ID:
1256525
4
GMP Phase I — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
24 Oct 2019 - 25 Oct 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:
1256579
5
Technical Writing — Technical and Regulatory Writing for FDA-Regulated Industry
14 Nov 2019 - 15 Nov 2019 • Boston, United States
Abstract:
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:
Phone: [+410 501 5777];     Email: pkumar@fdamap.com
Event listing ID:
1256556


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Last updated: 29 July 2019