DOSSIER MANAGEMENT

PREPARED BY : NAILA KANWALSenior Officer Regulatory Affairs.

The SEARLE Company Limited

Index1- Dossier

2- Dossiers and Regulatory Affairs

3- Benefits and Applications4- Effective Dossier

Management5- Aspects of Dossier

ManagementA) Planning

B) Formatting and CompilationC) Review

6- Key Software Skills

 

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.

 

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.

 

Dossier offers both sophisticated and easy-to-use features :

•Dossier is a key tool to simplify and secure document management. It includes all benefits and ability to manage even more complex documents.

 

BENEFIT :

Time saving and safeguarded against potential mistakes and oversights: this is what Dossier will do for us being Pharmaceutical, health Care

professional! 

APPLICATIONS:• For registration of

Pharmaceutical Products.•In Local market.

•In International market.

For renewal of registration of Pharmaceutical

Products.

  •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.

Effective Dossier Management

 

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 )

Effective Dossier Management

  Aspects of Dossier

Management1.Planning

2. Formatting and compilation

3. Review

  Aspects of Dossier

Management1.Planning

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

  Aspects of Dossier

Management2 - 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.

  Aspects of Dossier

ManagementFor 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. 

  Aspects of Dossier

Management3- 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.

  Aspects of Dossier

Management4- 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.

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.

Aspects of Dossier Management

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.

Aspects of Dossier Management

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.

Aspects of Dossier Management

Aspects of Dossier Management

2-Formatting & compilation 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 incomputer. 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.

Aspects of Dossier Management

•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. 

3- Review •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.

Aspects of Dossier Management

Key software skills for effective dossier management-

Proficiency in MS office .

Proficiency in Adobe Acrobat tools.

Aspects of Dossier Management