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    European Commission Updates Q&A on Safety Features for Medicinal Products

    The European Commission recently released an updated document setting out nine new and one revised frequently asked questions and answers on the implementation of the rules on the safety features for medicinal products for human use. Building off a previous update in November , five of the new questions deal with general issues, like whether medicinal products can carry more than one batch number, or whether during the transitional period manufacturers located in the E...
  • Regulatory NewsRegulatory News

    European Commission Revises Q&A on Safety Features for Medicinal Products

    The European Commission on Monday released a revised question and answer document regarding the implementation of the rules on the safety features for medicinal products for human use. Revisions in the document are related to two questions and answers, including one on if a pack bearing safety features is lawfully opened by, for instance, parallel traders or manufacturers replacing the leaflet, can the pack be resealed? The answer notes that in certain circumstances it ...
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    Regulatory Career Paths and Progression, Resources and Training, FDA Inspections, Cleaning Validation and a Preview of August

    Feature articles over the past several weeks highlighted regulatory affairs as a profession, including careers in regulatory advertising and promotion, possible pathways and career progression and resources and training for regulatory professionals. Other articles covered various types of inspections conducted by FDA and processes for cleaning validation in the pharmaceutical industry. Regulatory Careers Faderan's exclusive interview with the president of Cook Researc...
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    Biosimilars, 21st Century Cures Act, Clinical Trial Regulations, PDUFA, Global Regulatory Strategy and a Preview of May

    The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in May. Feature articles over the past several weeks have highlighted biosimilar intellectual property issues and key strategies being adopted by the innovator companies. Other articles covered regulatory changes impacting how premarket applications for combination products will be reviewed by FDA, aspects of the revised European clinical trial regulatio...
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    Regulatory Business and Strategy, Medical Device Regulations, Adverse Event Reporting Requirements and a Preview of April

    The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in April. Feature articles over the past several weeks have highlighted regulatory intelligence tools, the importance of collaboration between commercial and regulatory functions, regulatory activities for establishing a joint venture in Japan and successful strategies for outsourcing. Other articles explored key elements of FDA's latest draft guidance o...
  • Regulatory NewsRegulatory News

    Regulatory Focus Features Recap: July 2016

    Feature articles for July focused on managing regulatory information and systems and eCTD submissions. The regulatory industry is being challenged by the increasing complexity and rate of change associated with compliance related requirements, while also focusing on improving the efficiency of operations across the enterprise. For regulatory professionals, effective management of information and content is critical to managing interactions with health authorities on a ...