30/10/2014 Professional & Short Term Course
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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Groupware Training is offering Regulatory Affairs training in Hyderabad with real time faculties.To know more visit www.groupwaretraining.com or www.f...
Groupware Training is offering Regulatory Affairs with real time facultiesIntroduction to different types of Pharmaceutical productsBasic concepts on ...