Brookwood Global Products Brochure 2020

• ADVISOR NEWSLETTER • Clinical Research and Clinical Quality Assurance Advisor , known simply as ‘Advisor’, is a quick and easy-to-read newsletter, usually consisting of 8 pages, published 20 times per annum. • Helps busy clinical research and QA professionals to keep up to date with the latest news and information. • More than 450 issues published since 1997. • Single-reader and a variety of multiple-reader and bespoke electronic subscription options. Content includes: • Executive summaries of key laws and guidelines relating to clinical research in the ICH regions • Summaries of articles and information in other publications, press releases and on the internet • Changes in regulations, codes of practice, guidelines and new clinical research procedures • News from important meetings and conferences • ICH developments and progress • News, views and opinions about ICH GCP implementation • Solutions for compliance- related problems • Inspection and audit findings – lessons to be learnt • Clinical research methodology, statistical and legal issues • Quality assurance issues and procedures. ISSN2041-3661 16 JULY 2018 Issue425 NewFDAguidanceon incorporating the patient’s voice in regulatorydecisionmaking Individualpatients experience the effects ofdiseases,diagnostic procedures and therapiesdifferently.Eachpatienthas apotentially uniqueperspective,whichdiffers from those of otherpatients and healthcareproviders.Although theFDAhas included thepatient perspective in its regulatorydecisionmaking since the early1990s, it is only recently that the agencyhas truly acknowledged the expertise thatpatients and caregivers can bring to thedrugdevelopmentprocess. Thefirst of fournewdraft guidancedocuments explainshowpatient experiencedata canbe capturedmost effectively.Further information onpage2 u FDAprogrammes encouragemore women toparticipate in clinical trials TheFDA recently announced anumber of initiatives toboost the inclusion ofwomen in trials. These include educational outreach programmes, a consumer awareness campaign, and trainingwebinars on recruitment and retention. New research initiatives to advance FDAdecision-making and the understanding of sexdifferences will also be funded. Seepage 6 u Delay to implementationofUSCommonRule TheUSDepartment ofHealth andHuman Serviceshas issued afinal rule thatdelays, for a further 6months (from 19 July 2018 to21 January2019), the general compliancedate for the revisedCommonRule.Three “burden- reducingprovisions” of the revised rulemay,however,be adoptedduring the delayperiod.Theprimary aim of the revisedCommonRule is to reduce the administrative burden andbetterprotect subjects in themodern research context.Extending the implementationdate gives stakeholders additional time to become familiarwith thenew rule, and toupdate theirpolicies and procedures accordingly. Seepage 4 u Overviewoffirst2yearsofEMA’sPRIME scheme InMarch2016 theEuropeanMedicinesAgency (EMA) launched thePRIMEprioritymedicines scheme, to increase support for the development ofmedicines targeting anunmetmedicalneed.The voluntary scheme isbased on enhanced interaction and earlydialogue withdevelopers ofpromisingmedicines, to optimisedevelopmentplans and speedup evaluation so that thesemedicines can reachpatients earlier.ThroughPRIME, the agency further enables the accelerated assessment ofmedicines applications for thebenefit ofpatients.Having gained 2 years’ experiencewith the scheme, the agencyhas issued a reportdescribing the application of the eligibility criteria and the support received by applicants.Details onpage5 u European agencies aim to improve children’s access tonewmedicines TheEUPaediatricRegulation aims to improve thehealth of children inEurope, by facilitating thedevelopment of and access tomedicines forpatients aged 0–17 years.However, 10 years after the implementation of theRegulation, significant challenges remain in developingmedicines fordiseases that only affect children or thatmanifest themselvesdifferently in adults and children.TheEuropeanMedicines Agency is taking steps to rectify this. Ithas reported onproposalsdiscussed during a recentworkshop thatwill form the basis of an actionplan to ensure that safe,high-quality and ethically researched medicines reach thepaediatricpopulation more quickly.Learnmore onpage 3 u NewCBERguidance to advance thedevelopmentofgene therapies TheFDA’sCenter forBiologicsEvaluation and Research (CBER)has issued sixnewdraft guidance documents tounderpin thedevelopmentofnovel human gene therapies.Threeof thedocuments focus on gene therapies for specific indications.Theother three cover chemistry,manufacturing and control information; long-term follow-upobservational studies collectingdataon adverse events; and the testingof retroviral vector-based therapies.Seepage5 u ISSN 2041-3661 13 AUGUST 2018 Issue426 UK industry responds togovernment’sBrexitWhitePaper TheAssociationof theBritishPharmaceutical Industry and theBioIndustryAssciationhave released a joint statement in response to a governmentWhitePaperon theUK’s future relationshipwith theEU.Moreonpage3 u EMA identifiesgaps in industry’s readiness forUK’s exit from theEU AEuropeanMedicinesAgency (EMA) survey has identified gaps in thepharmaceutical industry’s readiness for the critical changes associatedwith theUK’s exit (Brexit) from theEUnextMarch.The survey found that more than40% ofmarketing authorisation holders arenot on schedule to complete theirpreparations for the impact ofBrexit. Given the continuinguncertainty around thenature of theBrexit agreement, concerns aboutpotentialdrug shortages are growing. Learnmore onpage4 u LatestMHRAGCP inspections report highlights areasofmajorweakness TheUK’sMedicines andHealthcareproductsRegulatoryAgency (MHRA)performed99GCP inspectionsduring the 12months to31March2017 andhasnow issued its annualmetrics report. Themajority ofMHRAGCP inspectins are carried outunder the risk-based complianceprogramme and are either systems- based or trial-specific.Comparedwith theprevious12-month period, theproportion of inspections ofnon-commercial sponsors decreasednotably,with renewed focus on commercial sponsors. Moreover, approximately one-quarter of all inspectionswere triggered inspections, relatig to either a seriousbreach report or an issuewith a centralisedmarketing authorisation application. Details onpage 2 u FDA strategy toutilise realworld evidence and improve clinical trials Recent yearshave seeing ahuge growth in the availability and linkage of awide variety ofhealth- andnon-health- relateddata resources.Unlikedata from randomised clinical trials, thesedata reflect realworld routine clinical practice.They could contributemuch to the regulatory process formedicinalproducts and theFDAhas announced its intention to capitalise on thispotential. Further information onpage6 u FDAfinalisesguidanceonusingEHRdata in clinical trials TheFDAhaspublishedfinalguidance entitled ‘UseofElectronicHealthRecord [EHR]Data inClinical Investigations’, whichprovides recommendationson theuseofEHRdata inFDA-regulated clinical trials.Moreonpage8 u ISSN2041-3661 2 JULY 2018 Issue 424 NewUS legislationprovides increased access to experimentaldrugs New “Right toTry” legislation in theUSAwill givepatients with life-threatening illnesses– andwhohave exhausted all treatment options and cannotparticipate in a clinical trial – access to experimentaldrugs thathave completedPhase I trials and are still indevelopment.However, increased access tounprovendrugs via thisnew routewillpotentially increase the risks forpatients.Given that only a fraction ofnewdrugs that completePhase I trials areultimately approved, andwith the success rate even lower for oncology drugs, it isunsurprising thatboth thepharmaceutical industry and theFDAhave expressed concerns about the new legislation.More onpage 2 u FDA issuesdraftguidance on including adolescents in adultoncology trials Adult oncology trials typically target patients aged 18 years or over,meaning that adolescents (defined as those aged 12–17 years) are generallynot eligible. Paediatric oncology trials are often performed years later,usually after adrughasbeen approved in adults. Consequently, adolescentpatientshave delayed access topotentially effective therapies.Tohelp address this situation, theFDAhas issuednewdraft guidance to facilitate the inclusion of adolescent patients in relevant adult oncology clinical trials at all stages ofproductdevelopment. Inherent in this approach is careful monitoring for anydifferential safety signals, appropriatepharmacokinetic evaluations and the full consideration of all relevant ethical requirements. Details onpage4 u Digital transformationofhealth and care toboostdata sharing in theEU TheEuropeanCommissionhas issued a set ofmeasures to enable safe access to and the sharing ofhealthdata in theEU.The proposals outlined in the ‘Communication onEnabling theDigital Transformatio ofHealth andCare in theDigital SingleMarket’ (whichbuilds on theGeneralDataProtectionRegulation) should lead tobetterdiseaseprevention andpatient-centred care, aswell as improved treatments.Theywill enable the cross-border exchange of full electronichealth records, voluntary coordination in sharing data and resources fordiseaseprevention and research, and capacity building forhealthcare authorities.More onpage 5 u Call forbetter transparencyofdata from FDApost-marketing requirements When theFDA approves anewdrug on the condition that specifiedpost-marketing requirements are fulfilled, the clear implication is that additionaldata areneeded to fullyunderstand thedrug’s risk-benefitprofile.Applicantsmust report to theFDA on theprogress of theirpost-marketing commitments, but a recent BMJ article suggests thatmore could bedone to optimise theuse of thedata.Further information onpage6 u 100thEMAManagementBoar meeting focusesonBrexit Brexit and the associated business continuity planning continue t be the keypriorities for theEuropeanMedicinesAgency (EMA). Such continuity lanningwillhelp theEMA tomaintain, as far aspossible, its core activities in relation to he evaluation,maintenance and supervision of medicines.With the full imact ofpotential staff losses from the agency’s relocation toAmsterdam yet tobe felt, the focus isunlikely to change in thenear future. Seepage 3 u Contact us for further information by email info@brookwood-global.com @