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

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Canada (1) - India (2) - Singapore (4) - Switzerland (1) - United Kingdom (1) - United States (10) - ALL COUNTRIES (19)

1
Course — FDA's Medical Device Software Regulation Strategy
28 Feb 2019 - 01 Mar 2019 • San Francisco, CA, United States
Abstract:
This seminar will focus on addressing these concerns and educating participants on FDA’s recent medical device software regulation strategies.
Contact:
Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
FDA mobile apps regulation, medical device software functionality, FDA and NIST software guidance, proprietary software, FDA medical device recalls, warning letters, risk management
Event listing ID:
1181855
2
Case Management Boot Camp: Strategies for Success in the Acute Care Setting and Beyond!
15 Mar 2019 • Chicago, IL, United States
Abstract:
All these topics and more will be covered in this jam-packed one-day program. The day will start with an overview of the state of the art in case management today, how we got here, and where we are going in the future. From there we will discuss the often-confusing subject of all the roles that occur in best practice departments.
Contact:
Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
"case management boot camp, case management training, case management workshop, affordable care act, accountable care organizations (ACOs), CMS rules, utilization management, NOTICE Act, HINNs."
Event listing ID:
1182793
3
Writing Technical Documents for FDA — Technical and Regulatory Writing for FDA-Regulated Industry
21 Mar 2019 - 22 Mar 2019 • Washington DC, 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.

The trainers will provide practical tips using examples on how to organize and deliver information into clear and readable documents, and how to edit, format, present and publish technical regulatory documents for most favorable reception by the regulatory agencies. The workshop will also discuss rules for writing documents intended for electronic submission to regulatory agencies. This one-of-a-kind workshop will provide technical, practical, logical and logistical tips for regulatory writers of all levels of skills.

Contact:
Phone: [410 501 5777];     Email: pkumar@fdamap.com
Event listing ID:
1177366
Related subject(s):
4
Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)
21 Mar 2019 - 22 Mar 2019 • Tampa, FL, United States
Abstract:
This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators.
Contact:
Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
"Latin America regulations, Latin America life sciences regulations, Latam life sciences regulatory requirements, Latin America pharmaceutical regulations, Latin America medical device regulations, Latin America biologics regulations, Argentina life sciences regulations, Argentina medical device regulations, Argentina biologics regulations, Brazil life sciences regulations, Brazil medical device regulations, Brazil biologics regulations, Mexico life sciences regulations, Mexico medical device regulations, Mexico biologics regulations, Latin America clinical requirements, Latin America pre-clinical requirements "
Event listing ID:
1182812
5
HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer
21 Mar 2019 - 22 Mar 2019 • Chicago, IL, United States
Abstract:
This session is designed to provide an intensive, one and a half-day training in HIPAA Privacy Rule compliance designed for both the seasoned HIPAA professional as well as the individual newly appointed to the position of HIPAA Privacy Officer, covering.
Contact:
Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
"HIPAA privacy rule, HIPAA regulations, HIPAA compliance"
Event listing ID:
1182800
Related subject(s):
6
Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings
28 Mar 2019 - 29 Mar 2019 • Philadelphia, PA, United States
Abstract:
In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors.
Contact:
Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
"conducting FDA meetings, investigational new drug (IND), investigational device exemptions (IDE) applications, investigational device exemptions (IDE) applications, guidance documents for drug and device submissions, IND and IDE application process, IND maintenance, orphan drug designation, IDE maintenance, humanitarian device exemption (HUD), investigational new drug application preparation"
Event listing ID:
1182918
Related subject(s):
7
FDA eCTD Training Seminar — eCTD Submissions of IND and NDA/BLA to the US FDA
04 Apr 2019 • Washington DC, United States
Abstract:
The eCTD training workshop will provide the attendees with step-by-step instructions in creating and submitting eCTD submissions for IND, NDA, BLA, and ANDA applications without the need for expensive tools or unreasonable efforts. This no-frills workshop aims to train in the minimum skills needed and provide hands-on practical tips to create eCTD submissions. The trainers will use their own case studies of how eCTD submissions were created and successfully submitted to the FDA using indigenous tools and expertise. Also discussed will be logistical issues associated with managing and maintaining eCTD compliance with regards to all regulatory submissions. This workshop will be beneficial to both the novices and experienced in the field.
Contact:
Phone: [410 501 5777];     Email: pkumar@fdamap.com
Event listing ID:
1177321
Related subject(s):
8
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:
1196638
9
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:
1196592
10
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:
1145503

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Last updated: 12 February 2019