4.50
(2 Ratings)
Regulatory Affairs certification-Drugs Exam Coaching – Batch-Code-002
Categories: Regulatory Affairs certification courses
About Course
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Welcome to our comprehensive online (In-class) course and self-paced learning, this course offers a holistic learning to clear Regulatory Affairs Certification in drugs exams (RAC-Drugs) RAPS, equipping you with invaluable knowledge for success in this evolving field, covering a spectrum of critical topics in
- Full product development and lifecycle for pharmaceutical and medicinal and related products, APIs, biologics and biotechnology products.
- US FDA requirements (30%).
- European regulations and guidance’s from the European Commission, EMA, and competent authorities (30%).
- Globally applicable regulatory practices* (40%). (*ICH, and WHO guidelines and standards).
- Critical thinking and analytical skills.
What Will You Learn?
- Regulatory intelligence
- b. Product development
- c. Risk management
- d. Licensing, application, and maintenance
- e. Post-market activities
Course Content
Regulatory Affairs certification- Drugs Coaching
Welcome to our comprehensive online (In-class) course and self-paced learning, this course offers a holistic learning to clear Regulatory Affairs Certification in drugs exams (RAC-Drugs) RAPS, equipping you with invaluable knowledge for success in this evolving field, covering a spectrum of critical topics in
Full product development and lifecycle for pharmaceutical and medicinal and related products, APIs, biologics and biotechnology products.
US FDA requirements (30%).
European regulations and guidance’s from the European Commission, EMA, and competent authorities (30%).
Globally applicable regulatory practices* (40%). (*ICH, and WHO guidelines and standards).
Critical thinking and analytical skills.
RAC-Drugs-Batch-005
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Demo Class-005
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US-Regulations-1-005
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US-Regulations-2-005
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US- Regulations-3-005
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US -4- 005
00:00 -
US -5-005
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US-6-005
00:00 -
US-7-005
00:00 -
US-8-005
00:00 -
US-9-005-Test-2-Q
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US-9-005 TEST-2-Q&A
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US -10-005
00:00
RAC-Drugs-Batch-004
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Demo Class-004
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1 EU REGULATIONS -004
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2 EU REGULATIONS -004
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3 US REGULATIONS -004
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4 EU REGULATIONS-004
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5 EU REGULATIONS-004
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6 EU REGULATIONS-004
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7 EU REGULATIONS-004
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8 EU REGULATIONS-004
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9 EU REGULATIONS-004
01:01:59 -
10 EU REGULATIONS-004
00:00 -
11 EU REGULATIONS-004
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12 EU REGULATIONS-004
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13 EU REGULATIONS-004
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14 EU REGULATIONS-004
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15 EU REGULATIONS-004
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16 EU REGULATIONS-004
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17 EU REGULATIONS-004
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18 EU REGULATIONS-004
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19 EU REGULATIONS-004
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20 EU REGULATIONS-004
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21 EU REGULATIONS-004
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22 EU REGULATIONS-004
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23 EU REGULATIONS-004
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24 EU REGULATIONS-004
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25 EU REGULATIONS-004
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26 EU REGULATIONS-004
00:00
RAC-Drugs-Batch-003
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1 US REGULATIONS-003
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2 US REGULATIONS-003
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3 US REGULATIONS-003
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4 US REGULATIONS-003
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5 US REGULATIONS-003
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6 US REGULATIONS-003
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7 US REGULATIONS-003
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8 US REGULATINONS-003
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9 US REGULATIONS-003
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10 US REGULATIONS-003
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11 US REGULATIONS-003
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12 US REGULATIONS-003
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13 US REGULATIONS-003
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14 US REGULATIONS-003
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15 US REGULATIONS-003
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16 US REGULATIONS-003
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17 US REGULATIONS-003
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18 US REGULATIONS-003
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19 US REGULATIONS-003
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20 US REGULATIONS-003
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21 US REGULATIONS-003
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22 US REGULATIONS-003
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23 US REGULATIONS-003
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24 US REGULATIONS-003
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25 US REGULATIONS-003
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26 US REGULATIONS-003
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27 US REGULATIONS-003
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28 US REGULATIONS-003
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29 US REGULATIONS-003
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30 US REGULATIONS-003
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31 US REGULATIONS-003
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32 US REGULATIONS-003
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33 US REGULATIONS-003
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34 US REGULATIONS-003
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35 US REGULATIONS-003
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36 US REGULATIONS-003
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37 US REGULATIONS-003
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38 US REGULATIONS-003
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39 US REGULATIONS-003
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40 US REGULATIONS-003
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41 US REGULATIONS-003
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42 US REGULATIONS-003
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43 US REGULATIONS-003
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44 US REGULATIONS-003
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45 US REGULATIONS-003
00:00
RAC-Drugs-Batch-002
RAC-Drugs-Batch-001
RAC -Drugs -Question & Answer Papers
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Video workshop 1-Q&A
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WS video 2
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WS video 3
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WS video 4
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WS video 5
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WS video 6
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WS video 7
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WS video 8
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WS video 9
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WS video 10
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WS video 11
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WS video 12
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WS video 13
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WS video 14
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WS Video 15
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WS video 16
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RAC Drug Workshop Slides – EU
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RAC Drug Workshop Slides – Global
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RAC Drug Workshop Slides – US
RAC Drugs -Batch -005-Clinical & Non clinical
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Demo class-005
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US RAC: Day -1: General Introduction I
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US RAC: Day -2: General Introduction II
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US RAC: Day -3 General Introduction III
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US RAC: Day – 4 Clinical Trial Applications
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US RAC: Day-5 Diversity in Clinical Trials
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US RAC: Day 6 Pediatrics I
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US RAC: Day 7 Pediatrics II
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US RAC: Day-8 MRCT I
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US RAC: Day-9 MRCT II
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US RAC: Day- 10 Clinical Trial Phases I
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US RAC: Day 11- Test 1
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US RAC: Day – 12 Non- Clinical Drug Development I (Old)
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US RAC: Day – 13 Non- Clinical Drug Development II (Old)
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US RAC: Day 15 GLP I (Old)
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US RAC: Day 16 GLP II (Old)
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US RAC: Day 17 Safety Pharmacology I (Old)
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US RAC: Day 19 Safety Pharmacology II (Old)
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US RAC: Day 20 Pharmacokinetics I (Old)
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US RAC: Day 21 Pharmacokinetics II (Old)
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US RAC: Day 23 Genotoxicity I (Old)
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US RAC: Day 25 Geno & Carcino II (Old)
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US RAC: Day 26 Carcinogenicity II (Old)
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US RAC: Day 27 Developmental Toxicity I (Old)
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US RAC: Day 28 Developmental Toxicity II (Old)
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US RAC: Day 12 Clinical Trial Phases II
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US RAC: Day 13 Clinical Trial Phases III
00:00
RAC-Drugs-Batch-004-Clinical & Non clinical
Student Ratings & Reviews
4.5
Total 2 Ratings
5
1 Rating
4
1 Rating
3
0 Rating
2
0 Rating
1
0 Rating
Very nice
Course is excellent.