Marketing authorizations, Advertising and marketing practices

Track 8: Marketing authorizations, Advertising and marketing practices Provisions And stipulations For regulative Control: Political can and commitment, Legislation responsibility, Compliance ways, Resources for the selling authorization operate, Fees and price recovery, Inventory of existing merchandise on the market, Pharmaceutical regulative Affairs practice And Markets, Rational choice of merchandise, Special access schemes, Biomedical product development: From boardroom to market, post marketing activities. operational activities includes: Transparency, Policies, body procedures, tips for candidates, Model form, Compliance strategies Communication among departments at intervals the DRA Relationship of evaluators with GMP inspectors, Relationship of evaluators with the standard management laboratories, purposeful relationship of the evaluators with the skilled consultive body, conferences with candidates, Procedures for appeals, Collaboration with different DRAs, Collaboration with World Health Organization, Use of external specialists as evaluators, Timeframes for process of applications, Publication of selling authorization selections, Review of applications for selling authorization of multisource (generic) pharmaceutical products: relevancy, Initial selections on choices for premarket analysis, analysis of information on quality, Quality of beginning materials, instrumentality labelling, pharmacology, medical specialty and clinical information, Product data, Interchangeability, issue of written marketing authorizations variations, community Code on medicinal products, periodic reviews, suspension and revocation of selling authorization.

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