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

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Belgium (2) - Germany (6) - India (1) - Italy (1) - Singapore (2) - Switzerland (1) - United Arab Emirates (2) - United Kingdom (3) - United States (20) - ALL COUNTRIES (38)

1
Workshop — 2 Day Workshop Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and The Americas
25 Apr 2018 - 26 Apr 2018 • Boston,MA, United States
Abstract:
Description

One of the first steps towards selling a Class II medical device or IVD in the United States is to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission. Technically, the FDA does not "approve" medical devices or IVDs for sale under the 510(k) process; the agency gives "clearance" for them to be sold in the U.S. We use the term "FDA approval" for simplicity. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1003001
2
Workshop — Current issues in assuring data integrity in life sciences : 2 Days Seminar
25 Apr 2018 - 26 Apr 2018 • San Diego CA, United States
Abstract:
Data Integrity is a major concern of regulatory agencies worldwide as evidenced by the increasing number of Warning Letters issued in that area. Some managements have proceeded to implement data integrity programs on the lines of those implemented in “big data”. This has resulted in the escalation of costs and it is disproportionate to the benefits gained. Some even wonder why they continue to receive Warning Letters in spite of spending the dollars to implement programs such as Data Governance etc. etc.
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1006660
3
Workshop — 2 Day Workshop Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and The Americas
25 Apr 2018 - 26 Apr 2018 • Boston,MA, United States
Abstract:
One of the first steps towards selling a Class II medical device or IVD in the United States is to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission. Technically, the FDA does not "approve" medical devices or IVDs for sale under the 510(k) process; the agency gives "clearance" for them to be sold in the U.S. We use the term "FDA approval" for simplicity. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1006735
4
Keystone Symposia Free Webcast: Drug Discovery - Current Trends in Medicinal Chemistry
26 Apr 2018 • online, United States
Abstract:
Today’s armamentarium of therapeutic products has expanded dramatically in recent years to include a cadre of biologics, such as antibodies, in addition to traditional small molecule chemicals (“drugs”). Nonetheless, nearly all of the top 100 most prescribed therapeutics continue to be small molecule drugs. Thus, drug discovery and its core disciplines – including medicinal chemistry – remain a hotbed of innovation. Given the continued importance of drug discovery, we assembled a diverse panel of practicing “drug hunters”.
Contact:
Attendee Services;     Phone: [970.262.1230];     Email: info@keystonesymposia.org
Topics:
drug development, drug discovery, biologics, pharmacology, medicinal chemistry
Event listing ID:
1043066
5
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:
1046891
Related subject(s):
6
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More
10 May 2018 • Palo Alto, United States
Abstract:
Failure to adequately assess and control your supplier/subcontractor pool can result in dire consequences for an organization. Assessing and approving your suppliers before placing the first order with them will eliminate many headaches for a medical device manufacturer.

While all of these reasons have varying degrees of validity, none of them articulate the best reason for having a robust supplier audit program. A good supplier audit program should allow an organization to assess and periodically re-affirm the ability of key suppliers to provide conforming product consistently, reliably and on-time. It should be one of the most important initiatives toward fulfilling the goal of having a sustainable supply chain.

Contact:
Ashutos Swain;     Phone: [888-717-2436];     Email: referral@complianceonline.com
Topics:
FDA supplier management training, supplier quality management, supplier quality agreement, supplier selection, supplier audits
Event listing ID:
1053761
7
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:
1032045
8
Seminar — 2 Day Workshop: Human Error: Why Human Error is the biggest downtime problem in the manufacturing sector and how to investigate, control, reduce, and prevent to improve results.
10 May 2018 - 11 May 2018 • New Brunswick, United States
Contact:
Conference Manager;     Phone: [844-267-7299];     Email: subscribe@worldcomplianceseminars.com
Event listing ID:
1054018
9
The Veterinary Drug Approval Process and FDA Regulatory Oversight
17 May 2018 - 18 May 2018 • Kansas City Marriott Country Club Plaza, MO, United States
Abstract:
The U.S. Food and Drug Administration’s Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. However, FDA does not regulate all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency.
Event listing ID:
1046904
Related subject(s):
10
Scoop - Top Targets of Fed HIPAA Enforcers & Simple Steps to Take Control
18 May 2018 • online, United States
Contact:
Roger Steven;     Phone: [800-385-1607];     Email: support@mentorhealth.com
Topics:
hipaa standards, hipaa privacy and security rules, hipaa information, hipaa enforcement, hipaa covered entity, hipaa exemptions, hipaa privacy standards
Event listing ID:
1049780
11
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
31 May 2018 - 01 Jun 2018 • DoubleTree by Hilton San Francisco Airport, CA, United States
Abstract:
This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD.
Event listing ID:
1046884
Related subject(s):
12
4th Annual ComplianceOnline Medical Device Summit 2018
07 Jun 2018 - 08 Jun 2018 • San Francisco, United States
Abstract:
Plan for successfully executing regulatory inspections by providing industry best practices. Panel discussions led by the former FDA office bearers and industry experts will provide a set of comprehensive strategies on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters. Attending this summit will enable you to improve and better prepare for your next inspections.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Event listing ID:
954485
13
HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer
07 Jun 2018 - 08 Jun 2018 • DoubleTree by Hilton San Francisco Airport, CA, United States
Abstract:
With the recent implementation of new HIPAA regulations in the HIPAA Omnibus Update of 2013, healthcare organizations are reviewing their compliance and making sure they have the proper policies, procedures, and forms in place. HIPAA Privacy Officers have been renewing their compliance activities and reviewing their documentation to make sure they can meet the challenges of the new rules and avoid breaches and penalties for compliance violations.
Event listing ID:
1046872
Related subject(s):
14
Designing and Sustaining New and Existing Product Stability Testing Program
07 Jun 2018 - 08 Jul 2018 • Orlando, FL, United States
Abstract:
This seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries in understanding the effective way to establish a new or modified product stability testing program. This program is an important part of a product's regulatory filing requirements as well as the determination of the shelf life or expiration date of the product.
Event listing ID:
1046870
15
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:
960022
16
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:
960012
17
How to Examine Critical Regulatory Requirements related to physician Practice Acquisitions
13 Jun 2018 • online, United States
Contact:
Roger Steven;     Phone: [8003851607];     Email: support@mentorhealth.com
Topics:
internal audit report writing, anti kickback statute, anti kickback law, stark law, stark violation, false claims act healthcare, healthcare anti kickback statute
Event listing ID:
1049873
18
Seminar — 2 DAY SEMINAR Effective Compliance Strategies for Complaint Handling, Medical Device Reporting and Recalls
11 Jul 2018 - 12 Jul 2018 • Boston,MA, United States
Contact:
Conference Manager;     Phone: [844-267-7299];     Email: subscribe@worldcomplianceseminars.com
Event listing ID:
1053962
19
HACCP — Principles and Application of Hazard Analysis Critical Control Point
08 Aug 2018 - 09 Aug 2018 • New York, NY, United States
Abstract:
The Principles and Applications of HACCP course is designed to teach participants how to develop, implement and maintain a Hazard Analysis Critical Control Point (HACCP) system. The training is presented over 2 days which cover the 5 preliminary steps and the 7 principles of HACCP. Practical examples and activities are provided to assist with development and implementation within your food business. Additionally, participants will learn techniques for managing both HACCP and pre-requisite programs to ensure food products are safe and suitable for customers and consumers. This course is facilitated by an International HACCP Alliance qualified trainer with a certificate of competency provided to all participants who successfully complete the in-course activities and assessments.
Event listing ID:
1046934
20
Seminar — 2018 Data Integrity Seminar : FDA/EU Requirements and Implementation
11 Oct 2018 - 12 Oct 2018 • Boston,MA, United States
Contact:
Conference Manager;     Phone: [844-267-7299];     Email: subscribe@worldcomplianceseminars.com
Event listing ID:
1053994

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Last updated: 22 April 2018