Topic outline

• Introduction to pharmaceutical regulatory affairs
  

  Introduction to pharmaceutical regulatory affairs

  Regulatory affairs is a profession developed from the intention of governments to protect public health by controlling the safety and efficacy of products including pharmaceuticals, veterinary medicines, medical devices, cosmetics so that that supplied products make a worthwhile contribution to public health and welfare.

  Regulatory Affairs is a unique combination of science and management to achieve a commercially important goal within a drug-development organization. 

   The drug development process is a lengthy, complex and extremely costly albeit necessary process. Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing.

  Regulatory Affairs is an attractive career choice for graduate students from a scientific background who enjoy communication and team work, are comfortable with multi-tasking and are eager to expand their knowledge in the wide realms of the Pharmaceutical world.

  It gives strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole.
• Course Information:
  

  Course Information:

  • Course Information:

    Name of the course: Pharmaceutical  Regulatory Affairs             

    Course Code: BPH 425 

    Total credits: 2

    Program: B. Pharm.

    
    
    

  • Course Instructor: 

    

    Mr. Md. Anamul Haque
    Assistant Professor
    Department of Pharmacy
    ID: 710002372
    Email: anamul.ph@diu.edu.bd
    Cell Phone:01767-290194
    Faculty of Allied Health Sciences
    Daffodil International University
    Dhaka, Bangladesh
    

    Personal webpage	LinkedIn	Goggle site	Goggle Scholar

• General Instruction/Guidelines for students:
  

  General Instruction/Guidelines for students:

  

  • All the students registered for this course have to enroll in Moodle.
  • Students can find all the course materials from Moodle.

  • All the students have to submit the soft copy of their "Assignment" in Moodle under assignment section created here and for this they will be graded here.

  • One discussion or feedback forum is created under each of the lecture Students have to give their feedback on these forum and marks will be given for their feedback

  • Any announcement regarding the class will be posted on Moodle. So they have to keep themselves always active on Moodle.

  • All the quizzes and presentation will be held on online (Moodle) and may be few of the class will be held on face to face class and it will be announced before the class.

  • The question pattern and the syllabus for the quizzes, midterm and final exam is given here under each of the section (quizzes, midterm and final).

  • There are Midterm and Final Examination presentation forum under these sections where students can discuss with each other about their midterm and final exam syllabus, any problem regarding the exam etc.
• Course details
  

  Course details

  Rationale:

  This subject deals with the registration process of drugs and drugs related materials.Licensing procedure for a pharmaceutical company and product as well.

  
  

  Course Learning Outcomes:

  • Explain basic requirements for drug registration. 

  • Illustrate different Stage and critical parameters of registration.

  • Keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products.

  • Advising on legal and scientific restraints and requirements

  
  

  Course Contents:
  

  1. Introduction to regulatory affairs and its scope.
  

  2. Drug  controlling authority of Bangladesh and pharmacy council.

  3. International regulatory agencies.

  4. QA and regulatory requirements in pharmaceuticals

  5. Acts, ordinance, policies regarding drug control in Bangladesh

  6. Approval procedure for new pharmaceuticals in Bangladesh

  7. Code of ethics for pharmacists.

  • General news and announcements Forum
  • Course curriculum File
  • Lesson plan File
  • Course outline File

    Total marks: 100                                                                                                                Total credits: 3
    Breakdown of marks
    Assessment types	Number of assessments	Marks in each assessment	Total marks
    Class test	3 class tests	10 marks	10 marks (Average)
    Assignment	1 assignment	5 marks	5 marks
    Presentation	1 presentation	5 marks	5 marks
    Attendance	Base on class attendance		5 marks
    Midterm exam	25 marks (Question types: MCQ,T/F,SQ)		25 marks
    Final exam	In two slots(Question types: MCQ,T/F,SQ)		40 marks
    Online activity	Case study, viva, interactive session  etc.		10 marks
    Total marks:			100

    
    

  • Assessment strategy File
  • Teaching strategy File
  • Recommended books File

    
    

  • DIU eLibrary   

    
    

  • Goggle Class Room 17PCA+C

    Goggle Class Room 17B

    
    

  • 
    

    
    

    GOOGLE MEET 17 PCA+C

    
    

    GOOGLE MEET 17 B

    
    

• .1. Introduction to regulatory affairs and its scope.
  

  .1. Introduction to regulatory affairs and its scope.

  
  

  
  

  

  Learning Outcomes:

  • Able to get general idea about regulatory affairs. 

  • Understand scope and areas of RA.

  • Figure out the goal of regulatory affairs.

  • Role of RAD in a pharmaceuticals.

  
  Course content:

  • Definition, scope & Goals for Regulatory Affairs.

  • Contribution of RAD in a pharmaceuticals.

  • Function of regulatory professionals.

  • Regulatory affairs basic intro URL

    
    

  • Chapter 1: Introduction to regulatory affairs File
• Question & Answer Forum (Drug regulatory affairs intro)
  

  Question & Answer Forum (Drug regulatory affairs intro)

  • Sharing knowledge & learning new things Forum
  • Interactive quiz (RA intro) Interactive Content
• 2. Drug controlling authority of Bangladesh and pharmacy council.
  

  2. Drug controlling authority of Bangladesh and pharmacy council.

      

    
  

  
  

  
  

  Learning Outcomes:

  • Able to get general idea about drug regulatory authority of Bangladesh.

  • Understand scope and areas of DGDA

  • Get idea about organogram of DGDA

  • Figure out Scope and functions of Pharmacy Council of Bangladesh.

  
  

  Course content:

  • Functions and activities of DGDA, 

  • Drug Control committee (DCC) and related technical committees.

  • Ordinance, different Committees

  • Pharmacy ordinance 1976. 

  •  Scope and functions of Pharmacy Council of Bangladesh.

  
  

  • 2. Drug regulatory authority in Bangladesh File
• Assignment
  

  Assignment

  
  

  • Assignment 425
• 3. International drug regulatory agencies
  

  3. International drug regulatory agencies

  
  

  Learning Outcomes:

  • Get general idea about International drug  regulatory agencies.

  • Learn about cGMP, ICH guidelines. 

  • Know the role and scope of FDA, MHRA,TGA.

  • Get into know about  ISO:9001

  
  

  Course content:

  • Introduction to international drug  regulatory agencies.

  • ICH and cGMP giudelines.

  • FDA, MHRA, TGA, ANVISA, GCC

  • ISO:9001

  • cGMP

  • 3. International drug regulatory agencies File
  • ICH GUIDELINES IN BRIEF URL

    ICH GUIDELINES IN BRIEF

    
    

    
    

• QUIZ 1
  

  QUIZ 1

  
  

  • QUIZ 1
• Mid term examination
  

  Mid term examination

  
  

  
  

  Mid-Term Exam:

  Total Marks: 15

  Total Time: 17 minutes

  Chapter : 

  1. Introduction to RA

  2. Drugs controlling authority in Bangladesh 

  3. International drug regulatory agencies.

  Assessment strategy:

  MCQ: 10 marks

  True/False: 5 marks

  
  

                                            Level 1: Ten questions relating to subjects topic and general idea.

                                             Level 2: Four  questions to judge understand ability of particular topics.

                                                             Level 3: Four  questions relating to elucidation of some pharmacological facts.

                          Level 4: Two  questions to assess students critical thinking.

  
  

  • MID TERM EXAM_BPH425_FALL 20 Quiz
• 4. QA and regulatory requirements in pharmaceuticals
  

  4. QA and regulatory requirements in pharmaceuticals

  
  

  Learning Outcomes:

  • Learn about  quality management system.

  • Know the components of QA

  • Will be introduced about importance of QA

  
  

  Course content:

  • Introduction to total quality management system.

  • Concept of QA and regulatory documents.

  • Importance of stability study.

  • Scope and function of QA.

  • 4. QA and regulatory requirements in pharmaceuticals File
  • Role of QA in pharma URL

    
    

    
    

• QUIZ 2
  

  QUIZ 2

  
  

  • QUIZ 2 BPH 425
• 5. Acts, rules, ordinance and laws regarding regulation of drugs in Bangladesh.
  

  5. Acts, rules, ordinance and laws regarding regulation of drugs in Bangladesh.

  
  

  Learning Outcomes:

  • Know about different laws.

  • Get idea about acts regarding drugs regulation.

  
  

  Course content:

  • The Poisons Act 1919

  • Pharmacy Legislation Drug Act 1940

  • Pharmacy ordinance 1976

  • Drug policy 1982

  • The Narcotics (Control) Act 1990

  • National Drug Policy 2016

  • Lecture slide Acts, ordinance, policies regarding drug control in Bangladesh - Copy File
• 6. Approval process, format and registration of pharmaceuticals in Bangladesh
  

  6. Approval process, format and registration of pharmaceuticals in Bangladesh

  
  

  
  

  Learning Outcomes:

  • Able to get general idea about pharmaceuticals registration procedure.

  • Get idea about product registration formalities.

  • Figure out the required documents  for a new pharmaceutical company.

  • How to conduct  a formal inspection and documentation.

  
  

  Course content:

  • Licensing procedure for a pharmaceutical company

  • Documentation for a new pharmaceuticals.

  • Role of drug control committee (DCC).

  • Recipe approval & pricing.

  • Block list and FSC.

  
  

  • 6. Approval procedure for new pharmaceuticals in Bangladesh File
• QUIZ 3
  

  QUIZ 3

  
  

  • QUIZ 3
• Presentation
  

  Presentation

  
  

  • Presentation BPH 425 Forum

    Topics

    FDA

    MHRA

    TGA

    ICH

    Dossier

    Drug Master File

    CTD

    DGDA

    QAD in pharmaceuticals

    Stability study

    QCD

    GMP

    Drug policy 1982

    Drug policy 2016

    
    Share the presentation video link of your assigned topics from the above by 25.11.2020
    
    

• Final examination
  

  Final examination

  
  

                                                           Final Exam Fall-2020

                                                               Total marks: 50

  Assessment strategy:

  Online Exam at BLC: 30 Marks Time 40 minutes

  MCQ 20 marks, True/False 10 marks

  Oral Assessment 15 Marks

  Online activity 5 marks

  Syllabus

   Quality management system in pharmaceuticals

   Act, laws and drug policies, Drug ordinance 1982

   Approval process of pharmaceutical in Bangladesh

  Question types

  Level 1: 15 questions relating to subjects topic and general idea.

  Level 2: 8 questions to judge understand ability of particular topics.

  Level 3: 4 questions relating to elucidation of some pharmacological facts.

  Level 4: 3 question to assess students critical thinking.

  
  

  • BPH 425 FINAL EXAMINATION Quiz
• Lesson of life
  

  Lesson of life

  

  
  
• Compliments
  

  Compliments