Regulatory Affairs Training Hyderabad|Online Learning India

30/10/2014 Professional & Short Term Course

Price: 15000.00 ₹

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Groupware Training provides Regulatory Affairs which is used to prepare documentation and make the students to work in realtime.

Ensuring that a company's products comply with the regulations of the MHRA;

keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to;

collecting, collating and evaluating scientific data that has been researched by colleagues;

developing and writing clear arguments and explanations for new product licences and licence renewals;

preparing submissions of licence variations and renewals to strict deadlines;

monitoring and setting timelines for licence variations and renewal approvals;

working with specialist computer software and resources;

writing clear, accessible product labels and patient information leaflets;

planning and developing product trials and interpreting trial data;

advising scientists and manufacturers on regulatory requirements;

providing strategic advice to senior management throughout the development of a new product;

project managing teams of colleagues involved with the development of new products;

undertaking and managing regulatory inspections;

reviewing company practices and providing advice on changes to systems;

liaising with, and making presentations to, regulatory authorities;

negotiating with regulatory authorities for marketing authorisation;

specifying storage, labelling and packaging requirements.

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Mobile: +91-9985523000


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