< PreviousLABORATORIESresponsibilities of individual personneland their roles are clearly defined, as isthe need for these members of a team ifany are not present. The guidelines are mostly brokendown into the different stages ofresearch, including test facilityorganisation and personnel - whichlooks into the responsibilities of theStudy Director, Principal Investigatorand Study Personnel. These aim toensure that studies are carried out in away that aligns with conductrequirements expected of the positions.There are also guidelines to indicateand set up expectations for therecording, documenting and archivingprocess. Following after that is QualityAssurance programmes, including theresponsibilities of QA Personnel withinthe lab. Facilities in general, whichinvolves not just test system facilitiesbut also facilities for handling tests andarchiving. Waste disposal is alsocovered, particularly with the hazardouss and dangerous nature of many by-products created in the lab. When it comes to study plans andreports, the GLP lays out requiredcontent for the study plan in terms ofaims and goals, details of the sponsorand any additional test facilities involvedin the tests, and much more. The goalhere is to ensure that any and alltransparency is observed when it comesto looking over or publishing the resultsof any tests. Scandals in past yearshave shown that labs sponsored byindividual companies may find resultsthat benefit those companies to thedetriment of scientific protocol. GLP canhelp reduce this, or at least putsafeguards into place that allowinvestigators to look back over theprocess and identify if this might be thecase.GLP has always been referenced assomething of a guideline, but for manycountries certain aspects - or theentirety - of it have been put into law.The European Union adopted two basicDirectives and a Decision relating to theapplication of the GLP principles in1987, while some changes were madeto this in 2004, much of it still doesapply. These include compulsory auditsand inspections to ensure that labfacilities conform to GLP rules andregulations. There are a number of Non-OECDmember countries who do not conformto GLP standards in labs. It is worthnoting that this does not discount thevalidity of their results, and in fact manyinteresting developments have comefrom countries who do not follow GLP.OECD regulations do not guaranteegood science or correct results, butrather then ensure that any resultsgathered can be easily reproduced in acontrol environment to ascertain thevalidity. Results generated in Non-OECDlocations might not have the sameeasily-followed paper trail, which canmake reproducing the trials to ensurevalidity almost impossible. Though some have criticised the GLPas being prohibitively expensive tofollow, mainly due to its requirement forcertain experienced staff members, it isno exaggeration to say itsimplementation has helped thepharmaceutical industry expand at arate far beyond its cost. Ultimately thesepractices have proven worthwhile andachievable for many across the world,so the validity of those who say itcannot be followed could be drawn intoquestion. 30Pharma Business International www.pbiforum.net28-31.qxp_Layout 1 08/06/2018 10:03 Page 3© Shutterstock /JJ IMAGE28-31.qxp_Layout 1 08/06/2018 10:03 Page 4Monday 18 – Wednesday 20 JuneInternational Conferenceon HIV/AIDS, STDs & STIsParis, FranceThis conference will offer delegatesdemonstrations, a chance to meet with currentand potential researchers and receive namerecognition. It attracts world-renowneddoctors, researchers, scientists and speakerswho converge to discuss and explore the mostrecent techniques, tactics and the newestupdates in the HIV/AIDS and STD space. Formore information, email hiv@meetingseries.org. Wednesday 20 – Thursday 21JuneChemspec Europe 2018Koelnmesse, Germany Chemspec is Europe’s premier sourcing andnetworking event for the fine and specialitychemicals industry. The exhibition is thecentral marketplace for manufacturers,suppliers and distributors of fine and specialitychemicals to meet with purchasers and agentslooking for specialised products or bespokesolutions. It provides an extensive educationPharmaEVENTSMonday 13 – Friday 17 AugustThe Bioprocessing SummitSheraton Boston, USThe Bioprocessing Summit convenes morethan 1,000 international bioprocessprofessionals to share practical solutions fortoday’s bioprocess challenges. Now in its tenthyear, the event has grown to include seventeendistinct conferences with weeklongprogramming on upstream and downstreamprocessing, analytical development and quality,formulation and stability, cell and gene therapyproduction, and manufacturing. For moreinformation, visitwww.bioprocessingsummit.com.© Shutterstock / Yoottana Tiyaworanan32Pharma Business International www.pbiforum.net© Shutterstock / Phimsriamong researchers, students, industrialprofessionals, pharmacists from all around theglobe. It is a campaign to create awarenessabout the recent advancements, research,breakthroughs, technology developed in thearea of drug discovery and development. Formore information, visitwww.drugdiscovery.pharmaceuticalconferences.com.programme of lectures and conference sessionson-site. In four designated lecture theatres,industry experts will hold talks and discussionrounds on a variety of industry topics. For moreinformation, visitwww.chemspeceurope.com/2018/english.Tuesday 21 JunePharmacoepidemiologyVenue TBCThis course is aimed at personnel inpharmacovigilance departments, druginformation and regulatory affairs departments,drug safety officers and pharmaceuticalphysicians as well as pharmacovigilancepersonnel working at regulatory agencies. It willprovided delegates with an understanding of thebasic principles of pharmacoepidemiology andtheir practical application. For more information,email info@management-forum.co.uk. Wednesday 27 – Thursday 28JuneDrug Designing 2018Pacific Gateway Hotel, VancouverAirport, Canada The conference aims to promote interaction32-33.qxp_Layout 1 08/06/2018 10:04 Page 1Sunday 1 – Tuesday 3 JulyEuro Virology 2018Vienna Euro Virology will comprise structured scientific sessions which coverall the aspects of viral diseases and virus research. It will bring togetheran exciting balance of industry and academia, so that delegates have theunique opportunity to network with colleagues from different sectors anddiscuss new research in the field of virology including discussions. Formore information, email eurovirology@microbiologyconferences.org.Sunday 1 – Monday 2 JulyWorld Cancer Summit 2018AVANI Atrium, BangkokThis summit takes aim at the main issues surrounding cancer as wellas future strategies. It promises to be the largest international conferencebridging the gaps between intellectuals from across the globe to enlightentheir research and findings. For more information, emailworldcancersummit@annualcongress.net.Monday 16 – Tuesday 17 JulyAdvanced Pharmacy Mercure Sydney, Australia This conference will provide a multi-channel communication platformthat brings together both producers and consumers of pharma world ofgeneric sector. It includes prompt keynote presentations, oral talks,poster presentations and exhibitions. For more information, visitwww.advancedpharmacy.pharmaceuticalconferences.com.www.pbiforum.netPharma Business International 33© Shutterstock / AtosanMonday 18 – Wednesday 20JunePharmaceuticalPackaging andLabelling Summit 2018Crowne Plaza, ZurichThis year’s Pharmaceutical Packagingand Labelling Summit will focus on newEU regulations, with a particular emphasison tamper evidence, as well as artworkand all aspects of packaging design andsecurity. For more information, emailenquire@iqpc.co.uk. Tuesday 28 – Thursday 30 AugustCPhl KoreaCOEX Convention and Exhibition Centre, SeoulThis conference programme offers you high-level session featuringopinion leaders from government and academia. As a leading learningplatform for trends and issues confronting the pharmaceutical industry inKorea and the region, the conference will give you a realistic assessment ofthe industry challenges and strategies for dealing with them. For moreinformation, email lisa.sant@ubm.com.32-33.qxp_Layout 1 08/06/2018 10:04 Page 2FEATURESOncology ExposéBiosimilars Clinical Testing RegulationEthics Next issue:Deadline - 25th July 2018REGULARSNewsEventsM&A Round-upPharmaBUSINESS INTERNATIONALVisit us atwww.pbiforum.netwhere you’ll find thelatest news as it breaks – and why not subscribe to ournewsletters so you can have thelatest news emailed to yourinbox, in betweenprinted issues?@pbiforumwww.pbiforum.netcompany/po-business-international34.qxp_Layout 1 08/06/2018 10:05 Page 1Next >