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DRIVESUCCESSFULANDEFFICIENTGLOBALSUBMISSIONMANAGEMENTTHROUGHA
BALANCEDOUTSOURCINGMODELNaviga8ngthecomplexi8esofglobalsubmissionstrategiesfororiginalandlifecycleapplica8onsdemandsaJen8ontoglobalsubmissionrequirements,experienceinunderstandingtheirimplica8ons,andtoolstoimplemen8ngthem.Abalancedoutsourcingmodelenablesacost-effec8vesubmissionandefficientreviewprocessforelectronicsubmissionsandassociatedmetadatamanagement.
OUTSOURCEORAUGMENTYOURSTAFFFORANEFFECTIVE,EFFICIENT,ANDCOSTSAVINGREGULATORYSUBMISSIONSPROCESS
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.
✔ “Percep8vepublishing”-documentinterpreta8on,guidanceonauthoring,andCTDplacement
✔ Leadersincontent-basedsubmissiondocumenta8onstrategy
✔ ProficiencyinLeadingGlobalSubmissions(knowledgeofglobalguidances)✔ ExpertsatGlobalSimultaneousOriginalApplica8ons✔ ExperiencewithDrugDevelopmentandLifecycleApplica8onsubmissions✔ Specializedpublishers(DocumentQC,Readiness,Cross-Referencing,
Hyperlinkingstrategies,etc.)
WHATTOLOOKFORINASUBMISSIONMANAGEMENTANDPUBLISHINGPARTNER(MAKINGTHEMOSTOFYOUROUTSOURCEDSTRATEGY)
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.
OUTSOURCETOSAVE
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,staffmee8ngs,reviews,etc.
EMPLOYEESVS.OUTSOURCEPARTNER
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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.
WHYARECOMPANIESPAYINGFORSERVICESTHEY'RENOTUSING?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 aPartnerthathas“livedinsidepharma”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.
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,ANDELECTRONICALLYSUBMIT
AGENCYREQUIREMENTS:ELECTRONICSUBMISSIONSFDA will require all NDA,ANDA,BLAandMasterFilesubmissions be in eCTD format by MAY5,2017. All CommercialINDsubmissions will be required in eCTD format by MAY5,2018. 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 FDAelectronicsubmissionsgatewayisrequiredfor 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 OCTOBER2018the European Union ClinicalTrialRegula8onEUNo.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
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NEWFDAMODULE1The 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
GETAHEADOFTHEREGULATIONS
NEWECTD4.0The 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
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FDATECHNICALCRITERIAAfter 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.
IDMPINEU:SPORThe 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.
For more information, please contact:
Mike SwalinaPartner Pyxa Operations Practice [email protected]
PyxaSolu.onsiscomprisedofadynamicteamofmanagementconsultantsandR&[email protected]&Ddeliverystemmingfromac.vi.esledbyRegulatoryAffairs
ABOUTPYXA
Dalia El-Sherif, PhD Partner Pyxa Consulting Practice [email protected]
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Contributing AuthorFrank FauncePrincipal Consultant Pyxa Solutions, [email protected]
Let us support you in leading your your submission work / tools, document preparation, report publishing, submission publishing, validation and submissions to the agencies.
Pyxaismanagedbyateamofthreeseasonedpartnersandcomprisedofasolidteamofconsultantswithpriorblendedexper.seinindustryandmanagementconsul.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.
