• Regulatory NewsRegulatory News

    Regulatory Focus Recap: February 2015

    February was a short month. Did you miss out on reading the Regulatory Focus feature articles ? Here’s a recap. If you're not a member of RAPS , see what you've been missing. February’s editorial theme was outsourcing. Check out all the articles on this topic: CROs: Selecting and Managing Contract Regulatory Development Resources Outsourcing Pharmacovigilance in Small Pharmaceutical Companies: A Perspective Outsourcing: Not My Problem? Pharmaceuti...
  • Feature ArticlesFeature Articles

    Out of Africa: Six Regulatory Articles that Span the Continent

    Africa has a rapidly growing populace and demand for safe, effective and trusted medical products. Different geographic areas of Africa are developing their medical products submission and approval systems at varying rates of sophistication dependent, in part, on internal resources. Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southe...
  • Feature ArticlesFeature Articles

    Regulatory Focus Recap: January 2015

     If January got away from you and you found yourself missing out on the Regulatory Focus feature articles, here’s a recap. The editorial theme for January was regulatory writing. Check out all the articles on this topic: Writing Skills for the Regulatory Professional “Cafeteria-Style” Approach to Training for the Regulatory Technical Writer Writing Regulatory Documents with E-Submissions in Mind Integrated Summaries of Effectiveness and Safety: ...
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    2014 RAPS Closing Plenary Will Touch on Benefit-Risk, Risk Mitigation in Global Healthcare

    Attendees at the 2014 RAPS Convergence closing plenary session will hear from four respected thought leaders about the global regulatory healthcare market. The panelists will discuss the complexity of delivering healthcare products to consumers around the world in a safe and cost-effective manner while dealing with shifting regulatory paradigms, regulatory science and regulatory capacity. Speaking at the plenary will be Martha Brumfield, PhD, from the Critical P...
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    2014 RAPS Opening Keynote to Address Global Healthcare Evolution, ‘Simplexity’

    When 2014 RAPS: The Regulatory Convergence opens in Austin, TX, 29 September, attendees will hear an opening keynote presentation from David Bosshart, PhD, CEO of the Gottlieb Duttweiler Institute (GDI). Bosshart, who holds a doctorate in philosophy and political theory, will discuss the continuing evolution of global healthcare, changes in consumer behaviors and expectations, advances in innovation and how this new environment will fuel changes in the global healthca...
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    Business Skills Crucial to Regulatory Professionals’ Success

    "Not to advance is to go back," says the Chinese proverb. That's one reason regulatory professionals need to continually improve their knowledge base. And, as their careers progress, that knowledge must include the business domain. Todd E. Chermak, RPh, PhD , divisional vice president, Abbott Nutrition Regulatory Affairs, Abbott Laboratories, Abbott Park, IL, had this to say about expanding regulatory affairs professionals' knowledge to include business functions: "Yo...