The Best Regulatory Affairs Courses

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Regulatory Affairs

• Elite Institute of Pharmacy Skills (EIPS)

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Introduction

• Regulatory affairs is a profession developed from
  the desire of governments to protect human health
  by controlling the efficacy and safety of
  products in areas including veterinary
  medicines,pharmaceuticals,pesticides medical
  devices, agrochemicals,complementary medicines,
  cosmetics and by the companies.

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Work flow
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Responsibility

• Keep in touch with international legislation,
  guidelines and customer practices
• Keep up to the date with a companys product
  range
• Ensure that a companys products comply with the
  current regulations.
• The Regulatory Affairs professionals job is to
  keep track of the ever-changing legislation in
  all the regions in which the company wishes to
  distribute its products. They also advise on the
  legal and scientific restraints and requirements,
  and collect, collate, and evaluate the scientific
  data that their research and development
  colleagues are generating.
• Formulate regulatory strategy for all appropriate
  regulatory submissions for domestic,
  international and/or contract projects.
• Coordinate, prepare and review all appropriate
  documents for example dossier and submit them to
  regulatory authorities within a specified time
  frame in conjugation with the organization.

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Qualities of a good RA professional

• Authoritative
• Team Player
• Decisive
• Resourceful
• Good Communication Skill
• Analytical Skill- Ability to evaluate the
  strengths and weakness of the technical and legal
  options open to a company.
• Good Informational Technology skills
• Negotiating Skills
• Able to re apply scientific and regulatory
  principles

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Importance

• A good Regulatory Affairs professional will have
  a approach and will play a very important role in
  co-ordinating scientific endeavour with
  regulatory demands throughout the life-cycle of
  the product, helping to maximise the
  cost-effective use of the companys resources.
  The Regulatory Affairs department is very often
  the right point of contact between the government
  authorities and the company. Officials respond
  much better to a company whose representatives
  are scientifically accurate and knowledgeable
  than to one in which these qualities are absent.

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Syllabus And Course Details

• Elite Institute is one of the best Institute
  which trains the students by giving them best
  coaching and learning technique.Here at elite
  students are career oriented and faculty at elite
  helps students to get their career goal
  achieve.At elite Institute there are different
  courses in which the student get involved for
  their future. Regulatory Affairs Course is one of
  it.
• Elite Institute of Pharmacy Skills Syllabus
• Course Duration 6 months
• Course Details

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Contact Us

• AddressElite Institute of Pharma Skills Office
  No. 211, 2nd Floor Laxmi Complex, Near Big Bazaar
  Off Old Pune Mumbai Highway Chinchwad,
  Pune-411019.
• Contact number91-7028042239, 9767901050
• Email-IDinfo_at_elite-pharmaskills.com
  regulatorycareer_at_elite-pharmaskills.com
• Websitehttps//elite-pharmaskills.com
• Twitterhttps//mobile.twitter.com/ElitePhama
• Facebookhttps//b-m.facebook.com/EliteInstituteof
  pharmaSkills/
• Linkedinhttps//www.linkedin.com/in/archana-gawad
  e-754820108/?originalSubdomainin

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