Newly Launched Regulatory Affairs Certification At EIPS

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Newly Launched Regulatory Affairs Certification
At EIPS

• Elite Institute of Pharma Skills

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Introduction

• The Regulatory Affairs Certification is a
  professional credential that denotes dedication
  to excellence, pursuit of understanding and
  career development. fulfillment at the RAC
  examinations requires know-how of an appropriate
  regulations and the capability to think
  critically approximately the regulatory problems
  and demanding situations that occur at some point
  of the healthcare product lifecycle.
  RAC-credentialed professionals are a few of the
  modern-day and rising leaders within the
  regulatory profession. to this point, extra than
  7,000 individuals have earned the RAC, some
  conserving a couple of credentials.

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Value of the Regulatory Affairs Certification

• The RAC is the handiest credential for the
  regulatory expert in the healthcare product
  quarter. The RAC demonstrates to employers,
  customers and colleagues that a regulatory
  professional has the essential information,
  abilities, crucial thinking skills and dedication
  to advancing professional understanding and
  abilities. as the demand for ready regulatory
  professionals will increase globally,
  RAC-credentialed experts are well placed to be
  effective crew participants and members in each
  paintings placing. reputation of the RAC
  continues to grow round the sector and
  RAC-credentialed experts earn higher salaries
  than folks that do now not keep the credential.

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RAC Examination Development Process

• Four different examinations and resulting
  credentials are available RAC United States
  (US), RAC European Union (EU), RAC Canada (CAN)
  and RAC Global. every exam is primarily based on
  a survey of the scope of exercise and particular
  roles and duties of regulatory specialists within
  the place of business with at the least 3 years
  of regulatory revel in. The examinations cope
  with prescribed drugs, biologics and
  biotechnology, medical devices, in vitro devices
  (IVDs) and regulatory capabilities in the course
  of the product life cycle. each exam consists of
  100 multiple-choice questions to be answered in a
  -hour time period. every exam affords a balanced
  mix of questions about product sorts, and people
  requiring critical thinking and analysis that can
  be carried out to any healthcare product. every
  exam is reviewed and revised yearly and content
  material is up to date for the October/November
  exam cycle.

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RAC Examination Development Process
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Eligibility Requirements

• To be eligible for the Regulatory Affairs
  Certification examination you need to meet one of
  the following educational and professional
  experience requirement combinations
• Baccalaureate or equivalent first university
  degree and a minimum of three years of regulatory
  or regulatory-related work experience
• Masters degree and a minimum of two years of
  regulatory or regulatory-related work experience
• Doctorate degree and a minimum of one year of
  regulatory or regulatory-related work experience

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Preparing for the Examination

• The RAC examinations are challenging so it's far
  vital to develop a take a look at plan to put
  together for the exam. Your plan ought to be
  based totally in your knowledge, revel in and
  preferred technique to mastering. here are a few
  things to keep in mind
• Review the examination content outline.
• Assess the scope and depth of your knowledge and
  experience
• Build and implement your plan

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Question Types

• The examinations consist of 100 multiple-choice
  questions. There are three types of questions
  included on each examination
• Recall
• Application
• Analysis
• Recall questions ask for specific information,
  typically about regulations and guidance that are
  important aspects of the regulatory process.
  These questions may relate to any stage of
  product development and may relate to regulations
  specific for product types.
• Application questions require relating specific
  knowledge to a situation that may be encountered
  in the scope of practice of a regulatory
  professional.
• Analysis questions may be described as a small
  case or example requiring the candidate to read
  and assemble information in order to identify and
  evaluate various solutions

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Career Scope

• There is a number of varied types of
  opportunities in this field. The regulatory
  affairs aspirants can be working with
  organizations like
• Ministry of health
• Pharmaceutical manufacturing companies
• pharmaceutical consultancies
• biotechnologies, medical devices
• diagnostics
• clinical research institute in pune and all
  places that are under the governance of
  Regulatory rules laid by the government.

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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. Contact Us For more details
• Elite Institute of Pharmacy Skills Syllabus
• Course Duration 6 months
• Course Details

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Contact Us

• Address Elite Institute of Pharma Skills Office
  No. 211, 2nd Floor Laxmi Complex, Near Big Bazaar
  Off Old Pune. Mumbai Highway Chinchwad,
  Pune-411019.
• Contact number 91-7028042239, 9767901050
• Email Id pharmaskills.elite_at_gmail.com
  info_at_elite-pharmaskills.com
• Website https//elite-pharmaskills.com
• Twitter https//mobile.twitter.com/ElitePhama
• Facebook https//b-m.facebook.com/EliteInstituteo
  fpharmaSkills/

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THANKYOU