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On the transparency front, it was a busy summer for the European Federation of Pharmaceutical Industries and Associations (EFPIA). In the wake of recent ‘Sunshine’ legislation in France and other EU countries, and pending transparency trials before the Court of Justice of the European Union (CJEU), EFPIA adopted no less than two brand new transparency documents: a Disclosure – ‘Sunshine’ – Code and joint Principles for Responsible Clinical Trial Sharing. It also significantly strengthened the advertisement commitments in its existing Code on Interactions with HCPs.

Beginning on 1 January 2014, French pharmacists are now legally permitted to substitute a biosimilar for the prescribed (reference) biological medicine as long as the prescribing physician has not marked the prescription as “non-substitutable.” According to the new law, substitution is allowed only when initiating a course of treatment, and if the biosimilar belongs to the same group as the prescribed product, known as a “similar biologic group.” The criteria for inclusion in a “similar biologic group” have yet to be defined by the French healthcare authority (ANSM).

This is a sample group and event sales agreement.

Learn how public companies in Canada can structure their board, develop policies and procedures, handle disclosure obligations, and recent corporate governance developments.

This guide provides comprehensive insight into banking regulation in 19 jurisdictions around the world.

This guide covers key topics including regulatory architecture, bank capital requirements, bank governance/internal controls, Fintech, and rules governing banks’ relationships with their customers and other third parties.

Brands have become the currency of international trade. For in-house counsel, high-quality brands provide a bond of trust with your client’s consumers. Ensuring that your client’s brands are legally secure and high quality is challenging, especially in the case of brand migration.

This is a sample software license agreement.

Learn about enforcement action taken by the US Centers for Medicare and Medicaid Services (CMS) in 2022 against hospitals, to enforce CMS's Hospital Price Transparency Rule that took effect on January 1, 2021.

You finally made it. No longer the lawyer, now the client. As head of regulatory affairs, you ask lawyers for advice (even though you know how to find the answers and often do). Life is less complicated, not having to worry about those pesky ethical rules. But are you really free of them? No one quite knows, although one can envision sanctions being imposed on a person who maintains her law degree in conduct that would clearly be violative of ethical norms. And the sanctions could adversely impact the client as well.

Make sure your new value-based fee structures with law firms are successful by focusing on forging long-term relationships, goal alignment, and solid project management. In this session, we’ll discuss how to assess firm project management capabilities, and ways to manage the outside counsel interface over the life of a matter to ensure you are satisfied with outcome. We’ll cover tools and techniques of successful project management, such as defining scope, requirements and milestones up front, conducting progress assessments along the way, ensuring the budget is on track (and how to anticipate and deal with variances), and concluding matters with assessments that foster continuous improvement.

In this multi-jurisdictional guide, explore an overview of key legal issues, rules and developments regarding Financial Services disputes across a range of jurisdictions.

This Wisdom of the Crowd (ACC member discussion), compiled from responses posted on the Nonprofit Organizations Forum, discusses whether it is common for non-profit entities to refuse to agree to representations & warranties in a contract.

In this article, the ABA amends the ABA Model Rules of Professional Conduct dated August 2012, to provide guidance regarding the ethical implications of retaining lawyers and nonlawyers outside the firm to work on client matters (i.e. outsourcing)

This InfoPAK is designed to provide corporate counsel with a general overview of employee benefits. The InfoPAK will focus on how ERISA and the Internal Revenue Code apply to health and welfare and retirement benefits provided by employers to their employees in the United States.

910 Hiring & Motivating Your Legal Team

A short briefing regarding the European Commission's proposed Regulation on a European approach for Artificial Intelligence (‘AI’).

Contract Lifecycle Management (CLM) is often caught in cross-functional turf wars. Consequently, many find that the system in place is not the hoped-for “silver bullet,” especially as unmet requirements surface across the organization. Moreover, the benefits documented in the CLM business case may always seem just beyond reach, especially as phased roll-outs stall amidst frustration and disappointment that what was pitched by the vendor turned out to be more difficult to actualize than it seemed.

By learning how to properly utilize jury consultants, in-house counsel can build upon their litigation expertise and highlight areas of the process that may be misunderstood.

This InfoPAK (now known as ACC Guides) gives a succinct overview of merger control, regulatory framework and regulatory authorities in Japan.

Gain a more fluent knowledge of global privacy issues and data sharing challenges through an experiential learning session. Learn more about where technology is leading the law on privacy issues. Understand how in-house counsel can better anticipate and plan for shifts and developments in the area of data privacy. Learn by participation and peer interaction. Participants will represent the many countries involved in the operations of a hypothetical global company that wants to gather and share employee data internally. As company representatives within their jurisdiction, they will negotiate with the regulators (faculty) on proposed cross-border solutions for data sharing.

Learn about data subject access requests (SARs) and global data privacy legislation and considerations for HR Strategists.

Learn corporate governance trends for public companies in the United Kingdom, following the publication of the annual review from the UK Financial Reporting Council (FRC) in light of the UK Corporate Governance (UKCG) Code.

Members respond to question of how to deal with an RFP requesting contract exceptions, particularly when dealing with a large corporation.

This checklist contains a sample list of questions that can be used as a starting point for conducting due diligence from a privacy and security standpoint.