Industry Training Services
Pharma To Market offers a range of industry training services to companies. We understand local needs for small, medium and large pharmaceutical and medical device companies. Training programs are tailored to account for your company size and requirements and are designed to meet the ongoing changes in the Australia/New Zealand/Asia market.
Our expert trainers lead participants in cultivating best practices for eSubmissions, document management, LORENZ docuBridge and industry standard software. We also provide full training services for installations of LORENZ docuBridge in Australia and New Zealand.
Our training courses can include the following aspects
- Introduction to CTD, NeeS, eCTD
- eCTD Readiness
- eSubmission transition strategies
- Lifecycle Management
- Advanced eCTD concepts
- On-site, off-site or online
- Regulatory submission pathways and strategy
- Country specific requirements
- Bioequivalence
- Pharmacovigilance
- Up-to-date industry insight
- Software training
- Writing compliant documents
- Document Management Systems (DMS)
- Interactive software demonstrations
- User friendly workbooks
- Customised training programs
- Online webinars
Authoring eCTD Compliant Documents
- History of eCTD and eSubmissions in Australia and around the world
- Benefits of eCTD and the differences from NeeS
- Document granularity
- eCTD technical elements
- ICH metadata
- Australian module 1 envelope
- Dossier compilation & publishing
- Validation
- Lifecycle management, sequences and operators
eCTD Educational Workshop for Australia
- ICH standards for document granularity and PDF formatting
- Creating templates with correct font & formatting properties
- How to create navigational aids including hyperlinks
- Using styles to create bookmarks & table of contents
- Best practices for processing PDF documents to ensure compliance
- eQC tracking and best practices
- Hands-on workshop
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What Our Training Attendees Say
Being able to work hands on with ‘dummy’ submissions was great. Trainers were responsive to participants’ questions and seemed keen to cover as much as possible in the time slot. Trainers were very knowledgable on the material and provided insights from both sides, the industry professional and the TGA.
Participant
Hands-on AU eCTD Workshop
The (Authoring eCTD Compliant Documents) workshop was an excellent overview of the documentation requirements for NeeS/eCTD submissions. The ‘hands on’ part of the training highlighted many features within Microsoft Word and Adobe Acrobat which will assist us in producing compliant documentation efficiently in preparation for future eCTD submissions in Australia.
Participant
Hands-on AU eCTD Workshop
The way that the exercises were run i.e. we were shown then told to do it afterwards independently. This enabled me to truly understand the process and gave me confidence with docuBridge. I was surprised how comfortable I felt with it given that I had never seen/used it before!
Participant
Hands-on AU eCTD Workshop
The one day (Authoring eCTD Compliant Documents) workshop was run very professionally. All the information provided was relevant and current. There was a very good balance of theory and practical exercises. The take home resources, including the educational workshop guide and the preformatted template (a word document) continue to be of great help in the day-to-day work of writing and formatting the Modules.
From a personal perspective, I have greatly appreciated the continued assistance from the Pharma To Market team in authoring publishable Modules.
Participant
Hands-on AU eCTD Workshop
The hands on aspect and also how it related directly to my work really took away some of the ‘fear of the unknown’. The IT setup was great and facilitator’s knowledge good and helpful.
Participant
Hands-on AU eCTD Workshop