CERTIFICATION COURSE IN CTD & DMF PREPARATION AND SUBMISSION

LIST OF THE TOPICS

1.      OVERVIEW OF COMMON TECHNICAL DOCUMENT (CTD)

2.      CMC DOSSIER PREPARATION AND REGULATORY COMPLIANCE

3.      eCTD

4.      PRACTICAL TRAINING ON DOSSIER PREPARATION

5.      STABILITY TESTING FOR PHARMACEUTICALS

6.      DMF PREPARATION AND SUBMISSION

7.      PRACTICAL TRAINING ON DMF PREPARATION AND SUBMISSION

8.      SITE MASTER FILE (SMF)

9.      DMF COMPLETENESS ASSESSMENT

10.  DMF FEES

11.  DMF IN GLOBAL PERSPECTIVE

12.  EFFECTIVE MANAGEMENT OF DOSSIER

13.  COMMON MISTAKES IN DOSSIER

14.  CERTIFICATE OF ANALYSIS

15.  ANDA SUBMISSION FILING

16.  IMPORTANCE OF PAS IN ANDA FILING

17.  505B2 Vs ANDA SUITABILITY PETITION A CASE BASED LEARNING

18.  NCE Vs 505B2 APPLICATION: A CASE BASED LEARNING

19.  FTF Vs 505B2: A CASE BASED LEARNING

20.  505B2 FILING: A CASE BASED LEARNING

21.  505B2: AVOIDING 30 MONTHS STAY OF ANDA MITIGATION

22.  CLIMATE ZONE

23.  COUNTRY SPECIFIC STABILITY ZONE

24.  STABILITY STUDY: A CASE BASED DISCUSSION

25.  STABILITY DATA FOR ZONE IV COUNTRIES

26.  ACCELERATED AND INTERMEDIATE TESTING CONDITIONS

27.  LONG TERM TESTING CONDITIONS

28.  TESTING FREQUNCY

29.  BRACKETING

30.  MATRIXING

31.  PK/PD IN DRUG DISCOVERY

32.  BIOEQUIVALENCE STUDY

33.  BIOEQUIVALENCE STUDY DESIGNS

34.  BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS)

35.  BIOEQUIVALENCE AND STABILITY STUDY REQUIREMENT

36.  BIOEQUIVALENCE AND DISSOLUTION DATA SUBMISSION

37.  GENERIC DRUG APPROVAL AND ADDITIVES LABELLING

38.  VARIATION MANAGEMENT

39.  VARIATION CLASSIFICTAION

40.  SETTING DISSOLUTION SPECIFICTAION

41.  REGULATORY REQUIREMENTS FOR BIOSIMILAR

✅CERTIFICATE: Receive a certificate upon successfully finishing this course

✅COURSE DURATION: 15 Hours)

✅LANGUAGE: English

✅SELF PACED LEARNING: Offered as an online course featuring pre-recorded videos and structured for distance learning, this program is available to participants globally.

✅LIFETIME ACCESS: You will have lifetime access to the course