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    Knowing Regulations Not Enough, Says Expert who Will Help Guide RAPS Exec Program Participants

    RAPS' long-running Executive Development Program , which brings rising regulatory leaders to the Kellogg School of Management at Northwestern University for four days of intensive business training, has been consistently popular because it fills an increasing need. Most regulatory professionals come from science- or engineering-oriented backgrounds, with relatively few having had business training or experience. The growing recognition of the strategic importance of regu...
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    Are You a Rising Regulatory Leader? Learn Business Skills at RAPS Executive Development Program

    As William C. Putnam, PhD, RAC, argues in a  Regulatory Focus  thought piece  on the need for business skills within the regulatory profession, "regulatory professionals need to have a comprehensive understanding of business, such as the business acumen provided by extensive on-the-job training, professional development programs or formal business training."  Regulatory Strategy Critical for Business Success The reasons for this are pretty clear. Regulatory issues can ...
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    Why Regulatory Professionals Need Business Training

    You are the senior regulatory professional in the board room overseeing a major development program. The program looks promising and all you need to be concerned about is the most expeditious and risk-free regulatory path to approval, right? Unfortunately, that is not the case. The regulatory development path is typically much more complex and there are many business factors that drive the ultimate development strategy design. The most successful development programs tak...
  • Regulatory NewsRegulatory News

    EMA Plots Out Priorities to Deal With Brexit Uncertainties

    The European Medicines Agency (EMA) on Monday released its Brexit Preparedness Business Continuity Plan, saying it will prioritize its core scientific activities, including urgent and significant public health threats relating to the safety and quality of medicinal products for human and veterinary use in the EU. EMA said it's planning a phased implementation of the continuity plan, and in its first phase it will temporarily suspend or reduce lower priority activiti...
  • Regulatory NewsRegulatory News

    MHRA Plans for the Future of Drug, Device Regulation Post-Brexit

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU. MHRA is pushing for a more international strategy that focuses on collaboration and engagement with key partners and stakeholders and continuing to partici...
  • Regulatory NewsRegulatory News

    EMA Explains How it Supports Article 58 Applications

    The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs). Background First introduced in Regulation (EC) No. 726/2004 in 2004, the Article 58 procedure allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in collaboration ...
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    Health Canada Details New Confidential Info Disclosures in Draft Guidance

    Health Canada is proposing to disclose more confidential business information (CBI) to eligible persons for the purpose of protecting or promoting human health or the safety of the public, according to new draft guidance. The disclosure of such CBI, approved under the Protecting Canadians from Unsafe Drugs Act (also known as Vanessa's Law) of 2014, stipulates that the Minister of Health may disclose CBI “about a therapeutic product without notifying the person to whose...
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    Chicago Workshop to Help Regulatory Pros Communicate More Effectively

    Most regulatory professionals do not have a background—or often any training at all—in communications. Yet they are called upon every day to be effective communicators. Whether it’s communicating with their peers on a regulatory team, colleagues in other areas within their organizations, upper management, regulators, researchers, contractors or others, regulatory pros need to be clear, establish credibility and influence people in different disciplines and at many d...
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    J&J’s Regulatory Executives Groomed as Business Leaders

    Over the past decade, life sciences companies have increasingly realized that regulatory expertise is a mission-critical business asset. The amount of time regulatory professionals spend on business and management-related duties has risen sharply at all job levels, according to RAPS’ own Scope of Practice & Compensation Study . Some, more forward-thinking companies are taking this a step further, actively grooming regulatory professionals to be business leaders and crea...
  • FDA Issues Guidance on Qualifying for Device User Fee Exemptions, Reductions

    Last week, the US Food and Drug Administration (FDA) released all of the updated user fees various regulated industries will need to pay to the agency in the coming 2014 fiscal year, including special exemptions for some medical device companies. Now FDA is out with a new guidance document meant to explain exactly which medical device companies are eligible for reduced rates, and how to determine eligibility. Background Since the Medical Device User Fee Act (MDUFA) ...
  • US Agency Launches Investigation Into Veterinary Pharmaceutical Industry

    The US Federal Trade Commission (FTC) is announcing an investigation into competitive issues in the veterinary pharmaceuticals market after concerns were raised to it regarding the pricing of medications and possible anti-competitive issues. "American consumers spend a tremendous amount of money on medications for their pets every year," FTC Chairman Jon Leibowitz explained in a statement. "High prices on these medications mean that consumers have less money for necessit...
  • FDA Releases Guidance on How to Qualify for Small Business User Fee Waivers

    The US Food and Drug Administration (FDA) has released new guidance on how small medical device companies can qualify as an FDA-approved small business and be eligible to pay reduced fees under the Medical Device User Fee Act (MDUFA) . FDA's Guidance for Industry and FDA Staff and Foreign Governments: FY 2012 Medical Device User Fee - Small Business Qualification and Certification  notes small businesses are authorized to pay "substantially reduced" fees under t...