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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
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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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New Zealand Risk Management Programme Guidelines for Non Bank Deposit Takers
- Industry: Banking and Financial Services
This document provides guidance to non-bank deposit takers in New Zealand in relation to the risk management programme requirements established under section 157M of the Reserve Bank Act 1989. Part 2 of this document notes some considerations in relation to risk management programmes and Part 3 provides some guidelines on how to interpret the main categories of risk set out in section 157M.
New Zealand Deposit Takers (Credit Ratings, Capital Ratios, and Related Party Exposures) Regula ....
- Industry: Banking and Financial Services
These regulations require deposit taking finance companies, building societies and credit unions in New Zealand to maintain a minimum capital ratio, and to limit the amount of credit they can provide to related parties.
New Zealand Capital Adequacy Framework (Internal Models Based Approach) (BS2B)
- Industry: Banking and Financial Services
This document sets out the methodology to be used by locally incorporated registered banks in New Zealand that have been accredited to use the internal models based approaches to calculating capital ratio requirements. This methodology is to be used for the purposes of determining these banks’ compliance with conditions of registration relating to capital and for disclosing information about capital.
New Zealand Capital Adequacy Framework (standardised approach) (BS2A)
- Industry: Banking and Financial Services
This document sets out the methodology to be used by locally incorporated registered banks in New Zealand that have adopted the standardised approach for calculating capital requirements. This methodology is to be used for the purposes of determining these banks’ compliance with conditions of registration relating to capital and for disclosing information about capital.
FDA Guidance: Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Mar ....
- Industry: Drugs and Chemicals (Pharma)
Non-prescription (OTC) drugs marketed without an approved application are also subject to adverse event reporting requirements, under section 760 of the Federal Food, Drug, and Cosmetic Act. A report of each adverse drug experience which is both serious and unexpected must be made to the Agency, as soon as possible, but no later than 15 days, after receiving information about the event.
FDA Releases Guidance For Manufacturers on Drug Shortage Notifications
- Industry: Drugs and Chemicals (Pharma)
In 2011, according to FDA, as many as 250 drug shortages have been traced, and a total of 195 drug shortages were prevented, as the Agency has taken proactive steps needed to increase available supply for patients in the U.S. The FDA recently released new guidance on how manufacturers can notify authorities on impending drug shortages.
FDA Biosimilars Draft Guidance - Quality Considerations in Demonstrating Biosimilarity to Refer ....
- Industry: Drugs and Chemicals (Pharma)
On February 9, 2012, the FDA released draft guidelines about quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and are based on key scientific and regulatory factors which should be considered for submission of applications for bio-similar products to the FDA.
FDA Biosimilars Draft Guidance - Scientific Considerations in Demonstrating Biosimilarity to a ....
- Industry: Drugs and Chemicals (Pharma)
On February 9, 2012, the U.S FDA released draft guidelines about scientific and quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and provide an overview of FDA’s approach in determining bio-similarity of a biologic product.
FDA Draft Guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifica ....
- Industry: Medical Devices
On December 27, 2011, the FDA released new draft guidance on 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications. The guidance aims to explain the decision-making process of FDA for determining substantial equivalence and provides additional details about the regulations, strategies, and norms upon which the FDA’s review of the 510(k) application is based. The guidance also provides information about new policies regarding Special 510(k) and Abbreviated 510(k) submissions to FDA.
Australia Therapeutic Goods Advertising Code 2007
- Industry: Drugs and Chemicals (Pharma)
In Australia, advertisements for therapeutic goods that are directed at consumers should get approved before broadcasting or publication and must comply with Therapeutic Goods Advertising Code.
The latest version is Therapeutic Goods Advertising Code (TGAC) 2007 which took effect on March 8, 2007.
Australian Anti-Money Laundering and Counter-Terrorism Financing Act 2006
- Industry: Banking and Financial Services
Australia’s legal framework to detect and deter money-laundering and terrorism, namely, the Anti-Money Laundering and Counter-Terrorism Financing Act 2006 (AML/CTF Act) lays down the obligations that are supervised and regulated by the Australian Transaction Reports and Analysis Centre (AUSTRAC).
EBA Guidelines on Internal Governance
- Industry: Banking and Financial Services
The European Banking Authority (EBA) has published its new Guidelines on Internal Governance. These aim at enhancing and consolidating supervisory expectations and improving the implementation of internal governance arrangements for individual institutions and the banking system as a whole.
UK FSA Risk Assessment Framework ARROW
- Industry: Banking and Financial Services
The Financial Services Authority (FSA) is a risk-based regulator and ARROW is the framework it uses to make risk-based regulation operational. ARROW stands for the Advanced, Risk-Responsive Operating Framework and covers all risks, firm-specific, thematic and internal.
UK Financial Reporting Council Turnbull Guidance - Revised 2004
- Industry: Banking and Financial Services
'Internal Control: Guidance to Directors' ("the Turnbull guidance") sets out best practice on internal control for UK listed companies, and assists them in applying section C.2 of the UK Corporate Governance Code.
FDA Draft Guidance on Evaluation of Sex Differences in Medical Device Clinical Studies
- Industry: Medical Devices
The FDA has issued a draft guidance that aims at increasing the representation of women in medical device clinical trials. Aimed at medical device manufacturers and developers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.
Federal Reserve Proposed Rule 2011 - Prudential Standards and Early Remediation Requirements fo ....
- Industry: Banking and Financial Services
On December 20, 2011, the Federal Reserve proposed new rules that would strengthen regulation and supervision of large US bank holding companies and systemically important nonbank financial firms.
EPA Final Rule: Mercury and Air Toxics Standards for Power Plants
- Industry: Energy & Utility
On December 16, 2011, the Environmental Protection Agency (EPA) issued the first ever national standards aimed at reducing the emissions of toxic air pollutants from power plants. The EPA was required by the Clean Air Act of 2000 to formulate and enforce these standards.
Proposed CMS Rule: Medicare, Medicaid, Children's Health Insurance Programs; Transparency Repor ....
- Industry: Drugs and Chemicals (Pharma)
The Physician Payment Sunshine Act was passed in 2010 as part of President Barack Obama’s legislative agenda to overhaul healthcare. The Centers for Medicine and Medicaid Services (CMS) was tasked with the drafting of the rules to enforce the Act’s requirements. CMS published its proposed rule in December, 2011.
Australian Prudential Standard 112 – Capital Adequacy: Standardized Approach to Credit Risk
- Industry: Banking and Financial Services
The Australian Prudential Standard 112 – Capital Adequacy: Standardized Approach to Credit Risk aims at ensuring that “ensure that an authorized deposit-taking institution holds sufficient regulatory capital against credit risk exposures.”
Australian Prudential Standard 110 – Capital Adequacy
- Industry: Banking and Financial Services
The Australian Prudential Standard 110 – Capital Adequacy aims at ensuring that “authorized deposit-taking institutions maintain adequate capital, on both an individual and group basis, to act as a buffer against the risks associated with their activities.”
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