White Paper: Outsourcing Submission Management
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Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs. Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.
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White Paper: Outsourcing Submission Management
- 1. 1 DRIVE SUCCESSFUL AND EFFICIENT GLOBAL SUBMISSION MANAGEMENT THROUGH A BALANCED OUTSOURCING MODEL Naviga8ng the complexi8es of global submission strategies for original and lifecycle applica8ons demands aJen8on to global submission requirements, experience in understanding their implica8ons, and tools to implemen8ng them. A balanced outsourcing model enables a cost-effec8ve submission and efficient review process for electronic submissions and associated metadata management. OUTSOURCE OR AUGMENT YOUR STAFF FOR AN EFFECTIVE, EFFICIENT, AND COST SAVING REGULATORY SUBMISSIONS PROCESS With an effective outsourcing submission management strategy, companies can use external vendors to either manage all agency submissions or augment their internal staff to assist with different responsibilities as they pertain to the publishing process. With that said, the submission management and publishing partner should be carefully selected, otherwise the entire strategy can back-fire, resulting in frustrated teams, increased costs and submission delays. ✔ “Percep8ve publishing”- document interpreta8on, guidance on authoring, and CTD placement ✔ Leaders in content-based submission documenta8on strategy ✔ Proficiency in Leading Global Submissions (knowledge of global guidances) ✔ Experts at Global Simultaneous Original Applica8ons ✔ Experience with Drug Development and Lifecycle Applica8on submissions ✔ Specialized publishers (Document QC, Readiness, Cross-Referencing, Hyperlinking strategies, etc.) WHAT TO LOOK FOR IN A SUBMISSION MANAGEMENT AND PUBLISHING PARTNER (MAKING THE MOST OF YOUR OUTSOURCED STRATEGY) Cost savings will come naturally if you select a qualified partner, selecting a partner on cost alone will end up costing you more in the long run and result in submission delays.
- 2. OUTSOURCE TO SAVE AN EXTERNAL SUBMISSION MANAGEMENT PARTNER IS AN EFFECTIVE WAY TO KEEP YOUR COMPANY FOCUSED ON ITS CORE COMPETENCY OF DRUG DEVELOPMENT WHILE COST EFFECTIVELY FILING GLOBAL SUBMISSIONS A typical employee will spend up to 20% of their normal work week completing general back office work like training, staff mee8ngs, reviews, etc. EMPLOYEES VS. OUTSOURCE PARTNER 2 Using a “qualified” submission management and publishing vendor can provide flexibility and knowledgeable specialists at any time, for any type of global application submission. An effective outsourcing model provides a company the ability to only pay for dedicated work to the service being provided. WHY ARE COMPANIES PAYING FOR SERVICES THEY'RE NOT USING? It is critical that companies are quickly and cost effectively able to complete and file their submissions without sacrificing quality. Therefore, when considering the submission management and publishing team, it is essential that the team is specialized in submission management and is able to rapidly understand the intricacies of the products and its applications and combine that with the requirements as defined in global guidances. Without this subject matter expertise, either speed, quality (or potentially both), will be compromised. In order to maintain such control and ensure high quality deliverables and services, companies tend to keep these teams – internal. Is that the right approach? Demand for Submission Management and Publishing services come in peaks and troughs. Maintaining a fully internal team, means that (1) if the team is staffed for “peaks” then the company will carry a work-force that is not utilized during troughs and (2) if the company is staffed for “troughs” then the company will be struggling to meet demands during periods of workload peaks and in many instances will staff projects with under qualified members just to get the work done. A solid Submission Management and Publishing Outsourcing strategy should be established with a Partner that has “lived inside pharma” and has successfully completed global submissions on-time and on-budget. Partners, who primarily use off-shore resources, while initially may seem attractive due to their “low cost”, will ultimately result in higher costs and delayed submissions due to the amount of re-work caused by inexperience.
- 3. Establishing electronic submissions allows re-use of documents and metadata for global submissions. The development of a global submission strategy allows for reduction of country specific documents. Paper is the way of the past and companies have to effectively move forward with eCTD. Several pharma companies are still operating in paper, and those who have made the transition to eCTD are not capitalizing on the efficiencies of a truly “Global” submission strategy. While the submission management systems are still behind (i.e. don’t enable simultaneous global submissions), business processes can be established and implemented to ensure these efficiencies are realized. A strategic outsourced submission partner should not only be savvy in electronic submissions and eCTD but also experienced in simultaneous global submissions; if they are not, then pharma will pay the cost (both $$ and time) for their inefficiencies. REDUCE, RE-USE, AND ELECTRONICALLY SUBMIT AGENCY REQUIREMENTS: ELECTRONIC SUBMISSIONS FDA will require all NDA, ANDA, BLA and Master File submissions be in eCTD format by MAY 5, 2017. All Commercial IND submissions will be required in eCTD format by MAY 5, 2018. Over 70% of the submissions CDER receives (other than master files) are already in eCTD. The agency wants them all in eCTD format. Using the FDA electronic submissions gateway is required for all eCTD submissions under 10 GB. Using electronic submissions with the gateway provides multiple acknowledgements of the receipt and processing of the submissions to allow for efficient review. eCTD submissions for Centralised submissions to the EMA are required and highly recommended for Mutual and Decentralised procedure submissions. By OCTOBER 2018 the European Union Clinical Trial Regula8on EU No. 536/2014 will require submission of Clinical Trial Applications for all member states be submitted electronically through the portal. Japan, Canada, Switzerland, Australia, New Zealand, Saudi Arabia, ASEAN, and many more countries require or accept different electronic submissions. ELECTRONIC SUBMISSIONS ALLOWS COMPANIES TO MEET AGENCY REQUIREMENTS / RECOMMENDATIONS AND ENABLE EFFICIENT REVIEWS 3
- 4. NEW FDA MODULE 1 The new FDA eCTD M1 allows for submission of advertising and promotional materials. FDA accepted the new M1 in June 2015. After a 24-month implementation period of the final publication of the guidance, paper copies will no longer be accepted. STAYING CURRENT ON ALL CHANGING REGULATIONS AND REQUIREMENTS IS NECESSARY FOR TECHNICAL ACCEPTANCE AND EASE OF REVIEW GET AHEAD OF THE REGULATIONS NEW ECTD 4.0 The next version of the eCTD will include: • New attributes and keyword • Additional lifecycle operators • Document ordering in the XML • Group titles for Module 4 • Two-way communication • Additional M1 changes for all regions 4 FDA TECHNICAL CRITERIA After December 17, 2016, all studies conducted must be performed using the standardized submission formats. Any study submitted to a marketing application must include a trial data summary dataset. For Commercial INDs studies submitted will need the summary dataset in 2017. IDMP IN EU: SPOR The IDMP implementation in the EU will be known as SPOR for Substance, Product, Organization, and Referential. As a benefit to Industry to implement SPOR, there is a proposal to the EMA that Type I variations could be solely submitted as metadata to the IDMP information instead of an eCTD submission. SPOR replaces xEVMPD in 2018 and is required for all approved drugs in the EU. In 2019, IDMP information will be required for all development products.
- 5. For more information, please contact: Mike Swalina Partner Pyxa Operations Practice Lead mswalina@pyxasolutions.com 610-427-9570 Pyxa Solu.ons is comprised of a dynamic team of management consultants and R&D subject ma@er experts specializing in cross-func.onal R&D delivery stemming from ac.vi.es led by Regulatory Affairs ABOUT PYXA Dalia El-Sherif, PhD Partner Pyxa Consulting Practice Lead delsherif@pyxasolutions.com 610-909-8831 5 Contributing Author Frank Faunce Principal Consultant Pyxa Solutions, LLC ffaunce@pyxasolutions.com 617-251-4402 Let us support you in leading your your submission work / tools, document preparation, report publishing, submission publishing, validation and submissions to the agencies. Pyxa is managed by a team of three seasoned partners and comprised of a solid team of consultants with prior blended exper.se in industry and management consul.ng. Pyxa takes pride in its successful delivery of global submissions, with unbeatable turn-around times and quality deliverables at a matchless cost. Our experience comes from forming and leading Submission Management teams internal to major pharma companies. Pyxa Solutions provides project management for the successful delivery of global original and lifecycle submissions. Our staff offers global submission guidance interpretation and document authoring support for paper, eCTD and NeeS submission compilation, publishing and delivery.