Newly Launched Regulatory Affairs Certification At EIPS - PowerPoint PPT Presentation

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Newly Launched Regulatory Affairs Certification At EIPS

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To cater to this huge demand in Pharmacovigilance training in India and Regulatory Affairs Certification has developed to meet to the ever increasing demand of a regulated way of functioning with the help of regulatory affairs course. The government rules to be implemented in a proper way it’s where the regulatory affairs professionals fit in. It obviously is the dedicated attitude of EIPS to take the responsibility to produce trained professionals in the field of regulatory affairs. – PowerPoint PPT presentation

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Date added: 13 April 2022
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Provided by: Elitepharma
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Title: Newly Launched Regulatory Affairs Certification At EIPS


1
Newly Launched Regulatory Affairs Certification
At EIPS
  • Elite Institute of Pharma Skills

2
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.

3
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.

4
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.

5
RAC Examination Development Process
6
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

7
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

8
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

9
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.

10
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

11
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/

12
THANKYOU
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