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Compliance Regulations and Guidance Affecting your Industry
Get trained on regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best practices to streamline quality and compliance processes and meet the regulatory demands.Categories
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Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
By - Christopher W. Olmsted
On Demand Access Anytime
By - Christopher W. Olmsted
On Demand Access Anytime
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How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
By - Madhavi Diwanji
On Demand Access Anytime
By - Madhavi Diwanji
On Demand Access Anytime
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FDA Guidance Clinical Studies Section of Labeling for Human Prescription Drug and Biological Pr ....
- Industry: Drugs and Chemicals (Pharma)
This guidance is intended to assist applicants in deciding:
(1) what studies should be included in the CLINICAL STUDIES section of prescription drug labeling,
(2) how to describe individual studies, and
(3) how to present study data, including presentation of data in graphs and tables.
FDA Guidance Adverse Reactions Section of Labeling for Human Prescription Drug and Biological P ....
- Industry: Drugs and Chemicals (Pharma)
The FDA-prescribed adverse reactions section makes it easier for healthcare practitioners to identify adverse reactions that are most important for prescribing decisions.
COREP Reporting Framework - Operational Risk - Template
- Industry: Banking and Financial Services
Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms. The EBA has made COREP the standardized reporting framework from 31 December 2012.
This template has to be used when reporting operational risk.
COREP Reporting Framework - COREP Market Risk - Template
- Industry: Banking and Financial Services
Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms. The EBA has made COREP the standardized reporting framework from 31 December 2012.
This template has to be used when reporting market risk.
COREP Reporting Framework - Explanatory Notes for Reporting Templates
- Industry: Banking and Financial Services
Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms. The EBA has made COREP the standardized reporting framework from 31 December 2012.
This document explains the terms used in the COREP templates.
COREP Reporting Framework - Documentation of Changes - Template
- Industry: Banking and Financial Services
Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms. The EBA has made COREP the standardized reporting framework from 31 December 2012.
This template has to be used when documenting changes.
COREP Reporting Framework - Credit Risk - Template
- Industry: Banking and Financial Services
Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms. The EBA has made COREP the standardized reporting framework from 31 December 2012.
This template has to be used when reporting credit risk details.
COREP Reporting Framework - Capital Group Solvency Details - Template
- Industry: Banking and Financial Services
Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms. The EBA has made COREP the standardized reporting framework from 31 December 2012.
This template has to be used when reporting capital group solvency details.
FDA Guidance - Medical Device Reporting for Manufacturers
- Industry: Medical Devices
This guidance document describes the new Medical Device Reporting requirements for manufacturers. It is intended for both domestic and foreign medical device manufacturers, and is based on the Medical Device Reporting (MDR) requirement published in the final rule dated December 11, 1995. The MDR regulation provides a mechanism for FDA to identify and monitor significant adverse events involving medical devices, so that problems may be detected and corrected in a timely manner.
FDA Guidance on Adverse Event Reporting to IRBs - Improving Human Subject Protection
- Industry: Clinical Research
The Food and Drug Administration (FDA) has issued guidelines for adverse event reporting because adverse event reports were found to be inhibiting, rather than enhancing, the ability of IRBs to protect the human subjects. Institutional Review Board (IRB) reviews and approves the clinical protocol, informed consent forms, study advertisements, and patient brochures.
FINRA Proposed Know Your Customer Rule
- Industry: Banking and Financial Services
In general, the new FINRA Know-Your-Customer Rule (2090) requires firms to use “reasonable diligence,” in regard to the opening and maintenance of every account and know the “essential facts” concerning every customer. This rule is modeled after the NYSE Rule 405(1).
FDIC Guidance on Safeguarding Customers Against E-Mail and Internet-Related Fraudulent Schemes
- Industry: Banking and Financial Services
The Federal Deposit Insurance Corporation has issued guidance on safeguarding customers against E-mail and Internet-Related Fraudulent Schemes.
Australian Prudential Standard APS 115 Capital Adequacy: Advanced Measurement Approaches to Ope ....
- Industry: Banking and Financial Services
In November 2007, Australia instituted the Australian Prudential Standard, APS 115 Capital Adequacy: Advanced Measurement Approaches to Operational Risk, under the Banking Act. This standard sets out the requirements that an authorized deposit-taking institution (that has approval to use an advanced measurement approach to operational risk) must meet both at the time of initial implementation and on an ongoing basis for regulatory capital purposes.
FDA Draft Guidance on Risk Information in Prescription Drug & Medical Device Ads, Promotional L ....
- Industry: Drugs and Chemicals (Pharma)
The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices.
PCAOB Staff Audit Alert No 5- Auditor Considerations Regarding Significant Unusual Transactions
- Industry: Banking and Financial Services
In April 2010, the Public Company Accounting Oversight Board (PCAOB) issued a guidance or Staff Practice Audit Alert, Auditor Considerations Regarding Significant Unusual Transactions, aimed at advising auditors on how they should handle significant unusual transactions while auditing a company.
Final Rule on Resolution Plans - Federal Reserve Board
- Industry: Banking and Financial Services
In October 2011, the Federal Reserve Board approved a final rule that will implement the resolution plan requirement, part of the Dodd-Frank Wall Street Reform and Consumer Protection Act. This important financial regulation requires bank holding companies with assets of $50 billion or more and nonbank financial firms designated by the Financial Stability Oversight Council for supervision by the Board to annually submit resolution plans to the Board and the Federal Deposit Insurance Corporation (FDIC). This rule will come into effect from November 30, 2011.
FDA Draft Guidance on Human Factors and Usability Engineering to Optimize Medical Device Design
- Industry: Medical Devices
In June 2011, the Food and Drug Administration issued draft guidance on using human factors and usability engineering to optimize medical device design. The aim of this guidance document is to help the medical device industry in conducting appropriate human factors testing and identifying device features that manufacturers should optimize throughout the total product life cycle.
FDA Guidance on Warning and Precautions Labeling for Drugs and Biological Products
- Industry: Drugs and Chemicals (Pharma)
In October 2011, the FDA issued final guidance on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Prescription Drugs and Biological Products. The aim of the guidance is to help ensure that labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
Regulation P - PRIVACY OF CONSUMER FINANCIAL INFORMATION
- Industry: Banking and Financial Services
The US Federal Reserve Board’s Regulation P or Privacy of Consumer Financial Information (12 CFR 216) regulates the use of nonpublic personal information about consumers by financial institutions.
OSHA’s New Laboratory Safety Guidance
- Industry: Laboratory Compliance
On October 13, 2011, OSHA announced the release of a new and revised Laboratory Safety Guidance document aimed at protecting lab workers from exposure to chemical, biological and physical hazards.
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