Regulatory Affairs Training Hyderabad|Online Learning India

30/10/2014 Professional & Short Term Course

Price: 15000.00 ₹

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Description


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.


To know more visit www.groupwaretraining.com or www.facebook.com/groupwaretraining


Contact:


Mobile: +91-9985523000


Email: training@groupwaretraining.com

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