The document discusses dossier management for regulatory affairs. It defines a dossier as a collection of detailed information about a subject. Effective dossier management involves planning, formatting, compilation, and review. Key aspects include understanding regulatory requirements, compiling information in a clear format, and cross-checking for errors before submission. Proficiency with software like MS Office and Adobe Acrobat is important for dossier management.

1. DOSSIER MANAGEMENT

2. Index
 1- Dossier
 2- DossiersandRegulatory Affairs
 3- BenefitsandApplications
 4- EffectiveDossierManagement
 5- Aspectsof DossierManagement
 A) Planning
 B) Formatting and Compilation
 C) Review
 6- KeySoftwareSkills

4. DOSSIER
It s a complete set of document.
•A collection of papers giving detailed information about
particular person or subject.
Dossier and Regulatory Affairs :
Dossier helps ,
•To create, assemble, update and publish a composite
document(s) from various individual document sources
and formats.
•A compound document is resulting from a dynamic
merge and assembly of elementary documents
monitored by a structuring and publishing agent (the
Dossier module).
•Elementary documents might be of heterogeneous
types and formats. They should be managed as a whole.
For instance, a training manual can be made up of Word
documents, Powerpoint presentations, Excel
spreadsheets . It is published and made available to all
users as a single document.

5. Dossier and Regulatory Affairs :
• All documents are managed as a single, consistent,
structured and unified document. No more time wasted
on assembling and maintaining a constantly moving
document means immediate return on investment.
•Each document or sub dossier follows its own lifecycle.
Individual changes update in real time the whole dossier.
•Dossier allows various combinations of the same
content in order to adapt to different contexts or targets:
FDA approval, other regulatory approval,
suppliers/customers needs, auditing purposes, etc.

8. APPLICATIONS:
• For registration of Pharmaceutical
Products.
•In Local market.
•In International market.
For renewal of registration of
Pharmaceutical Products.

9. •The registration dossier for
medicines is an important document
which is submitted for review to
regulatory agencies by
pharmaceutical companies for
approval to market their medicines.
• Utmost care should be taken during
its compilation and filing as it plays
a direct role in earliest possible
availability of medicines in the
market which in turn translates into
business for the company.

10. Regulatory affairs professionals need
to ensure the safety, quality and
efficacy of the medicines for which
they are filing registration dossier.
Note : The dossiers could be anything
among DMF, ASMF, ANDA, NDA or
MAA.
(DMF = DRUG MASTER FILE)
(ASMF = ACTIVE SUBSTANCE MASTER FILE )
(ANDA = ABRRIVIATED NEW DRUG APPLICATION )
(NDA = NEW DRUG APPLICATION )
(MAA = MARKETING AUTHORISATION
APPLICATION )

12. Deadline-It is important to know the
deadline for filing the dossier and action
plan should be prepared so as to meet the
deadline.

13. 2 - Understanding the registration
requirements of respective agencies-
Although most of the regulatory agencies
accept the CTD format for registration
dossier, the requirements for
approving marketing applications may
vary for individual agencies.

14. For example- USFDA requires Batch
Manufacturing Records to be provided,
while it is not necessary for approval by
European regulatory agencies. Hence it is
necessary to completely read and
understand the guidance document of each
regulatory agency before going ahead with
filing registration dossier with them.

15. 3- Requirements Listing-
Listing down all the requirements for
preparing the registration dossier. Listing
down all the requirements for preparation
of all the modules and their respective
sections is an important aspect.

16. 4- Sending the requirements list to
respective departments-
Preparing an individual requirement list and
sending them to each respective department. For
example I need to have all the information
regarding the general properties, synthetic
scheme, manufacturing process development of
drug from R & D department and finalized
specification & test procedures, Batch
manufacturing sheets from Quality assurance
department.

17. Format-
As per the ICH's M4 guideline the following are
recommended-
1- The display of information should be
unambiguous and transparent.
2- Text and tables should be prepared using margins
that allow the document to be printed on both A4
and 8.5 x 11” paper (For Europe and Japan regions A4
paper is recommended and 8.5 x 11” paper for USA).
3- Times New Roman, 12-point font is recommended
for narrative text.

18. 4- The left-hand margin should be sufficiently large that
information is not obscured by the method of binding.
5- Font sizes for text and tables should be of a style and
size that are large enough to be easily legible, even after
photocopying.
6- Every page should be numbered, according to the
granularity document.
5- Acronyms and abbreviations should be defined the
first time they are used in each module.

19. 6- References should be cited in accordance with the
current edition of the Uniform Requirements for
Manuscripts Submitted to Biomedical Journals,
International Committee of Medical Journal Editors
(ICMJE).
7- All pages of a document should include a unique
header or footer that briefly identifies its subject matter.

20. The following compilation aspects are important-
•The information should be specific, clear, precise and
accurate.
•Typographical and grammatical errors should be avoided.
•The information should be arranged in a sequential order in
computer. Each module could have a separate folder and in
turn each section of a module could have a separate folder.
•This kind of orderly arrangement will help in easy access of
information and help in taking printouts of finalized copy
conveniently.

21. •The line spacing should be preferably single.
• All the documents received from other departments should
be cross-checked so as to ensure that they are free from errors.
•Ensuring the specifications & test procedures are designed in
accordance with ICH guidelines .
•After the finalized soft copy is ready, printouts should be
taken using a good quality printer and arranged sequentially
in a module and section wise manner.

22. •It is important to re check the information in the
dossier before filing it with regulatory agencies.
•It is also important that a dossier meant to be filed
with a regulatory agency should be cross verified by a
person other than the one who has complied the
dossier.
•It is very useful to have a check list so as to ensure that
all the required information is present in the dossier
before submission to regulatory agency.

23. Key software skills for effective dossier
management-
Proficiency in MS office .
Proficiency in Adobe Acrobat tools.