The PDMA Alliance: Improving the Understanding of Drug Distribution Laws and Regulations

The annual Sharing Conference began over twenty years ago when a group of pharmaceutical executives came together to discuss the impact that the Prescription Drug Marketing Act of 1987 was having on their everyday responsibilities related to sample accountability. This group came to be known as The PDMA Alliance, a not-for-profit organization that presents an annual “Sharing” Conference for a diverse membership of industry executives and vendor partners. Conference registration is enhanced with the addition of year-round membership benefits for all participants, accessible through the Alliance website. Alliance membership and conference participation have been extended to include the medical device community, a sure sign of the organization’s ongoing outreach and continuing growth.
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New EU Clinical Trials Regulation

On 16 June 2014 a new Clinical Trial Regulation entered into force in Europe. It will apply no earlier than 28 May 2016.
The new regulation presents a major step forward in harmonizing clinical trial assessment process in the EU. For years, Europe was criticized for having too complicated, non-harmonized, nationally driven procedures for clinical trial assessment which often resulted in timely unpredictable and divergent assessment conclusions. Sponsors were faced with numerous country-specific protocol amendments as result of different opinions of one-country’s Competent Authority and Ethics Committee compared to opinions of other EU countries or even different opinions of Ethics Committee compared to national Competent Authority of the same country. In any case, Sponsors could expect any combination of decisions and close follow up by national experts was necessary.
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‘Long Arm of the Law’ Against Corruption Gets a Little Longer

Government’s reach extends to third party intermediaries when it comes to bribes, graft
Governments are broadening efforts to stamp out bribes, kickbacks, slush funds, and other forms of corruption. In particular, anti-bribery efforts are focusing upon prohibited cash payments, a lack of supporting documentation, and graft in the form of gifts, hospitality, and entertainment. Pharmaceutical, biotech, and medical device companies are particularly vulnerable because their supply chains, drug development programs and customer bases are expanding globally. The complexity, competitiveness, and highly regulated nature of these industries exert pressures that may lead some third party players to seek “shortcuts” that skirt the law or the manufacturer’s policies.
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Making Strategy Happen

The Pharmaceutical Industry continues to go through significant changes that present both challenges and opportunities. As a result, many companies are responding by developing bold and transformational strategies as they try to set the stage for future success. Setting the right strategy is not easy. It often means “placing bets” on which markets will enable growth, which therapeutic areas to focus on, what business segments to divest and invest, and how to transform business models. But the real challenge is not developing and setting the strategy. The real challenge is aligning the organization to effectively implement the strategy and “making strategy happen”.
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Use of Web-Based Collaborative Tools to Support Continuous Improvement Processes

In today’s data driven world, compliance officers within the pharmaceutical industry must have the ability to oversee a clear data trail which allows a full picture of all pertinent documentation and processes. Although, it is not a standard industry practice, more and more pharmaceutical companies are turning to web-based collaborative tools, such as SharePoint, to manage their processes and data.
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Is Valeant’s Offer for Allergan the New Roadmap for Biopharma Acquisitions?

Earlier this year, Valeant Pharmaceuticals International, Inc. teamed up with the hedge fund Pershing Square Capital Management, L.P. to acquire Allergan, Inc. in a hostile transaction. It is the first time that a major strategic acquirer has been known to team up with a major activist hedge fund in this way. The arrangement provided Valeant with a way to advance its agenda after its repeated friendly overtures to Allergan had been rebuffed. Does this provide a blue print for future acquisitions in the biopharma industry? It is too early to tell whether Valeant and Pershing Square will prevail. However, there are reasons to doubt that other biopharma acquirors will rush to do copycat deals, even if the hedge fund industry embraces the new technique.
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