Overcoming Challenges in CTD/eCTD compilation

Medicinal products are defined as a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. Medicines are fundamental to global healthcare system. In order to provide adequate access to medicines, the pharmaceutical companies have to overcome the challenges for their medicine’s registration process.

How to cut time & resources in time-consuming processes?

Create a Flowchart of your processes in RA:

• Collect and visualize all information during the following steps:
• Creation of documents
• Data flow
• Data revision
• QA & approvals
• All your involved departments are required to provide collated comments/feedback, so that the information within the functional line is consistent.
• Work out any differences in interpretation before trying to approve the final doc.

RA is the gatekeeper for communication between MAH/DP Manufacturer & global HAs.

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Plan for your workflows:

Approval processes, status, dates, records, etc.

• Use of templates for authoring eCTD ready documents (granularity & file formats)
• Use of a file system or DMS to manage the files
• Set your internal roles & responsibilities for the various steps of the process
• Who is authoring docs, QA, approving, filing & interfaces?
• How is version controlled in docs? And how are your submissions established?
• Set your archiving sequences

Time Management?

• Document creation tools:
• Do you have a template?
• Are the granularity & the doc characteristics complying with the eCTD specifications?
• Ready-Made Templates
• eCTD authoring tools
• Special functions
• Shortcuts for content re-use
• Process Optimization (Gap analysis)
• Planning & Tracking
• Distribution of work / responsibilities
• Due dates & tracking
• Re-Use of Data in your global submissions
• Identify your top priorities

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Planning & Tracking

• Define the timelines & interdependencies of:
• Authors
• Reviewers
• Approvers
• Publishers
• Plan ahead:
• Reserve / block resources
• Plan for substitutes for busy and critical times
• Handling your submissions in more than one territory
• Consider IT maintenance:
• Check IT infrastructures regularly
• Protect your deadlines during hot phases
• Align any updates or IT changes outside of hot phases
• Make sure your system is up to date beforehand
• Planning & tracking tools:
• MS Excel
• Professional tools?

Real-time reports and analytic dashboards, automated processes, workflows and project management functionality all combine to give your projects the best chance to succeed.

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SOPs, Processes & Guidelines

Establish SOPs:

• Minimum information to be included.
• Include the activities, main responsibilities, tasks.

Defined Processes & Guidelines:

• Who does what and when?
• Schedule the deadlines for your changes & submissions.
• Classify your quality changes into 4 reporting categories: Major, Moderate, Minor, No Impact.

Professional assistance and review

Assign an expert leader to review your business & processes:

• Leadership should:
• Map out review schedules of docs
• Assign your team work
• Clarify Responsibilities:
• Who writes the document?
• Are there a review & approval cycles?
• How do you manage the document lifecycle?
• Are module 1 documents included in your process etc.?
• Identify Key Persons in your process, especially during critical review of docs:
• Assure key persons won’t become “bottlenecks” in busy times
• Assure key persons can control multiple overlapping demands

Key persons must have specific skills each, unique in the team.

• Goal: avoid bottleneck effect!
• How to prepare for this in advance?
• How you deal with this when it happens?
• How to set focus?
• Important: Training in multi-tasking!
• Publishing & validation system, available options are:
• In-house software
• Host rental system
• Outsourcing service
• Responsibilities:
• Authoring eCTD ready documents
• Reviewing
• Submission of a dossier
• Maintenance of a dossier
• You have to discuss in your organization the appropriate decision for publishing (e.g. whether your company has to purchase software or use outsourcing service)

Implementing eCTD software

Do it yourself? What you need to consider:

• Related IT infrastructure changes, new server / hardware
• Inter-connectivity, DMS connection, training, planning ahead, budget
• Maintenance, regular updates
• IT outsourcing as an option?

Outsourcing of Publishing – Preparation

• How is the organization of the regulatory group in your company?
• (i.e. global, regional or local)
• Publishing Volume:
• How many submissions are you
• expecting per year?
• In which countries?
• Non-eCTD submissions (electronic or paper)
• Are they still needed?
• How can you create them out of the system?
• Is it necessary to create custom non-CTD structures for dossiers?
• How can such a structure be built up?
• How to handle your submissions in more than one country?
• Reduce redundant work
• Plan re-use of content where possible

Outsourcing of Publishing – Best Practice

• You should have a backup plan to cover peak times
• (e.g. outsourcing some tasks on high peak work load)
• Be aware of your team’s output capability
• Stay with the same publisher!
• Plan your publishing & submission process:
• who compiles the dossiers?
• who sends the dossiers to customers and authorities?
• what archiving system is in place?
• Using a friendly eCTD creation tool

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