Sentences with phrase «conducted by regulatory authorities»

Clifford Chance has deep knowledge and extensive experience in advising companies experiencing a dawn raid conducted by regulatory authorities in Europe, Asia and the United States.

Not exact matches

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

We do this by conducting clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.

In addition, all Golden Rice field trials in the Philippines are conducted under permits issued by the Bureau of Plant Industry of the Department of Agriculture (DA - BPI), the national regulatory authority in the Philippines for crop biotechnology R&D, after they established that the trials will pose no significant risks to human health and the environment.

Stakeholder consultations were conducted within jurisdictions using the arrangements determined by jurisdictional authorities, major employing authorities and teacher regulatory authorities.

Developing, issuing and enforcing safety regulations are a significant portion of PHMSA's work; however, PHMSA also conducts research, funds State regulatory authorities, emergency responders, and representatives of communities affected by hazardous materials transportation, and educates stakeholder groups — including the general public — through outreach initiatives and training.

What's more, Wizzcash is regulated by the Financial Conduct Authority, the regulatory body that is responsible for the conduct of the financial services industry.

Our teams of specialist criminal defence lawyers represent corporate and individual clients throughout regulatory and criminal investigations conducted by The Financial Services Authority (FSA) enforcement division.

Our lawyers have acted for architects, engineers, lawyers, dentists, and accountants in professional errors and omissions claims, advised clients before professional regulatory bodies, acted for professional administrative bodies, provided advice regarding investigations conducted by administrative authorities, and have acted in judicial reviews of decisions made by professional regulatory bodies.

It shrinks the broad, unfettered discretion [the prior framework gave] the relevant regulatory authorities to conduct a compliance audit of an ILP, albeit only of an ILP, to a discretion which is properly exercised only in response to conduct which has or is alleged to have occurred in the past — and conduct which inevitably comes to attention only haphazardly, in ways which underreport conduct which ought attract regulatory scrutiny by many tens, if not hundreds of times.

Recent work includes the defence of a large financial institution in connection with the LIBOR and FX investigations conducted by the Criminal and Antitrust Divisions of the DOJ, the CFTC, the SEC, the FCA and a range of other international criminal, competition and regulatory authorities across Europe.

Clifford Chance's Dawn Raids App is the first to offer advice on handling of raids conducted by over 80 regulatory authorities globally, such as, for example, raids conducted by judiciary and administrative authorities, including competition, tax and market authorities and more.

She advises clients on a wide range of privacy - compliance initiatives, including conducting privacy and security reviews and audits; drafting privacy policies, practices and procedures; managing privacy / security breaches; assisting with investigations by privacy regulatory authorities; and drafting outsourcing and other service - provider agreements involving transfers (including transborder flows) of personal information.