GMP & GDP Forum 2021

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The EuropeanGMP & GDP FORUMFace-to-Face22-24 JUNE 2021RemotelyHEIDELBERG, GERMANY LIVE ONLINESPEAKERS & MODERATORS:Dr Bernd RengerQualified Person, Immediate Past ChairmanEuropean QP Association, GermanyMaria SekamwaSurgipharm, UgandaDr Franz SchönfeldDistrict Government of Upper Franconia, GermanyDr Wolfgang SchumacherChairman ECA Data Integrity & IT Compliance Group,SwitzerlandLance SmallshawUCB Biopharma sprl, Chairman ECA Cannabis Group,BelgiumDr Ingrid WaltherPharma Consulting Walther, Former Head of theBusiness Unit iv Drugs, FreseniusJochen HeinzelF. Hoffmann-La Roche, SwitzerlandDr Afshin HosseinyQualified Person, Chairman ECA Foundation andEuropean GDP Association, UKSaddam HuqGlaxoSmithKline, U.K.Ib AlstrupGxP IT Medicines Inspector with the DanishMedicines Agency, DMA, DenmarkDr Christopher BurgessQualified Person, Chaiman ECA QualityControl Group, UKCheryl ChiaLotus Phoenix Consulting, NetherlandsLoretta DouganJazz Pharmaceuticals, IrelandPrabjeet DulaiGDP & Quality Matters, UKDr Rainer GniblGMP Inspector, District Government of UpperBavaria, GermanyDr Ulrich KisselChairman, European QP Association, GermanyGert MoelgaardChairman ECA Validation Group, DenmarkHelga PetersSwitzerlandAxel RadkeTrust Expertenservice, GermanyJonathan RileyAstellas Pharma Europe Ltd** ALL PARTICIPANTS RECEIVE AN EXCLUSIVE PACKAGE OF NEW ECA GUIDELINE DOCUMENTS FURTHER INFORMATION INSIDE **THE ECA FOUNDATION GROUPSECAQPAn ECA Foundation Interest GroupECAAnalyticalQuality ControlGroupAn ECA Foundation Interest GroupECAGDPAn ECA Foundation Interest GroupECAData Integrity &IT ComplianceGroupAn ECA Foundation Interest GroupECAPharmaceuticalMicrobiologyGroupAn ECA Foundation Wor king GroupECAValidationGroupAn ECA Foundation Interest GroupECAVisual InspectionGroupAn ECA Foundation Interest GroupECAATMP GroupAn ECA Foundation Interest GroupECACannabisGroupAn ECA Foundation Working Group

WELCOMEDear Colleagues,I would like to invite you to the European GMP & GDPForum from 22 – 24 June 2021.Our ECA members are familiar with biennial conferenceson GMP and GDP we have been running for several years.However, we have now developed this unique Forum bycombining the European GMP Conference and theEuropean GDP Forum. I believe with this new event bycombining both GMP and GDP subjects, we have created a new opportunity foryou to meet delegates and expert speakers from across the industry, andexchange views and learn about the whole Pharma supply chain challenges.We have dedicated day 1 to GMP, day 2 will be a combination of both GMP, andGDP and the final day will be focussed on GDP topics only. This will allow youas a participant to take advantage of the event based on your personal needsand interest in the specific subject areas, you can now choose to attend theforum just for one of the three days, two days or all three days.We intend to host the Forum every two years which I am sure will become amajor European event for GMP and GDP professionals. For our first Forum inJune 2021 we have invited speakers from Regulatory Authorities and Pharmaceutical Industry to share and discuss with you the latest GMP & GDPdevelopments.I look forward to meeting you either live online or in person in Heidelberg,Germany – one of the most beautiful cities in Europe!Yours sincerely,Dr Afshin Hosseiny, Chairman of the ECA Foundation Advisory BoardTARGET GROUPThe conference is of particular interest for GMP experts of pharmaceuticalcompanies (e.g. QA, QC, production, regulatory affairs), of GMP inspectoratesand Regulatory Authorities. It is also of interest for all personnel involved inGDP – pharmaceutical storage, transportation, cold chain and distributionactivities and the control of these activities.

MsGeneral terms and conditionsIf you cannot attend the conference you have two options:1. We are happy to welcome a substitute colleague at any time.2. If you have to cancel entirely we must charge the following processing fees:- Cancellation until 2 weeks prior to the conference 10 %,- Cancellation until 1 weeks prior to the conference 50 %- Cancellation within 1 week prior to the conference 100 %.CONCEPT HEIDELBERG reserves the right to change the materials, instructors, or speakers without notice or to cancel an event.If the event must be cancelled, registrants will be notified as soon as possible and will receive a fullrefund of fees paid. CONCEPT HEIDELBERGwill not be responsible for discount airfare penalties orother costs incurred due to a cancellation.Terms of payment: Payable without deductions within 10 days after receipt of invoice.Important: This is a binding registration and above fees are due in case of cancellation or nonappearance. If you cannot take part, you have to inform us in writing. The cancellation fee will thenbe calculated according to the point of time at which we receive your message.In case you do not appear at the event without having informed us, you will have to pay the fullregistration fee, even if you have not made the payment yet. Only after we have received yourpayment, you are entitled to participate in the conference (receipt of payment will not be confirmed)! (As of January 2012).Phone / FaxCityZip CodeP.O Number (if applicable)D-69007 HeidelbergStreet / P.O. BoxImportant: Please indicate your company’s VAT ID NumberCompanyTitle, first name, surname MrGerman law shall apply. Court of jurisdiction is Heidelberg.Privacy Policy: By registering for this event, I accept the processing of my Personal Data. ConceptHeidelberg will use my data for the processing of this order, for which I hereby declare to agreethat my personal data is stored and processed. Concept Heidelberg will only send me informationin relation with this order or similar ones. My personal data will not be disclosed to third parties(see also the privacy policy at privacy.html). I note that Ican ask for the modification, correction or deletion of my data at any time via the contact form onthis website.E-mail (please fill in)CountryDepartmentParticipation: in Heidelberg Remotely I will decide laterI would like to attend on the folowing days: Day 1 Day 2 Day 3ONLY ON DAY 2: PARALLEL SESSIONS – PLEASE CHOOSE ONE Qualification & Validation: Supplier integration - how does this fit with GMP? Quality Control: How sure are you that your Laboratory Instrument/System is fit for its intended Purpose? Data Integrity: Data Integrity in the GMP area GDP: How to Identify and Manage Falsified Medicines in the Supply Chain GDP: Risk Management in GDP WarehousePLEASE NOTE: You can already register now and decide later how you will participate– face-to-face in Heidelberg or remotely.GMP & GDP FORUM 2021, 22-24 June 2021, HEIDELBERG, GERMANY & LIVE ONLINEReservation Form (Please complete in full)CONCEPT HEIDELBERGPostfach 10 17 64Fax 06221/84 44 34If the bill-to-address deviates from the specification to the right,please fill out here:

WELCOMESESSIONIntroduction – Update ECADr Afshin Hosseiny, Chairman ECAIndustry Meets InspectorsPROGRAMME 22 JUNE – GMP PARTTo be namedModerated by: Lance SmallshawSESSIONGMP Inspections from Russian Authority in EuropeGlobal Inspection Management: Cultural Differences to considerin hosting Competent Authorities from e.g. Arabic Countries,China, Korea, Taiwan, Mexico, RussiaThis session will discuss the latest changes and current initiatives in GMPand GDP regulations. Helga Peters, Basel, Switzerland General Organisation Roles and Responsibilities Preparation Cultural AspectsGMP Update 2021 and Outlook 2022 –Current Trends and Developments in Europe and the USAnnex 1 Revision: Comments from the IndustryCurrent GMP Initiatives Worldwide Dr Bernd Renger, QP and immediate past chair of the EQPA Major GMP developments and their impact for pharmaceutical industry GMP Revisions – Annex 1 & 21 GMP for Marketing Authorisation Holders The new EU GMP Annex 21 on Importation and its implication Analytical Procedure Development and Validation (ICH Q14/Q2) Other GMP Developments from EMA, FDA and others Brexit and its consequences for the European QPsICH Q 12: Views and Expectations of a GMP-Inspector Dr Franz Schönfeld, GMP Inspector Quality Risk Management Life Cycle Approach Views and ExpectationsHow to Implement ICH Q 12 into Daily Practice of Manufacturers– What QA (and QPs) needs to know? Dr. Ulrich Kissel, Chairman European QP Association What does QA (and QPs) need to consider? Some Quality systems become key Efficiency potential for Quality systems of manufacturing organizations ICH Q12 and key performance indicators Plan precisely, assess risks proactively, share transparently Dr Ingrid Walther, Head of ECA s adhoc Task Force for comments to theAnnex 1 revision New requirements? New requirements! The role and importance of Quality Risk Management Contamintation Control StrategyInspection – readiness for new Annex 1: Comments from theInspector Dr Rainer Gnibl, GMP Inspector What is essential? What do I need to change or improve? Is it really such serious?PROGRAMME 23 JUNE –GMP & GDP PARTModerated by: Dr Urich KisselBrexit: Consequences for GMP and GDP Environment Dr Afshin Hosseiny, Chairman ECA Foundation and European GDPAssociation What is the impact of Brexit on Pharma Regulations? New GMP and GDP expectations from UK How Pharma Industry in EU should manage the UK business What impact all this has on the patients?GMP & GDP FORUM 2021 22-24 June 2021 Heidelberg, Germany & Live Online

EU GMP Annex 21: Import of Medicinal Products Dr. Ulrich Kissel, Chairman European QP Association The meaning of importation within scope of Annex 21 What is new in Annex 21 (draft)? What do we miss in Annex 21 (draft)? Conclusions and comments on the documentPARALLEL SESSIONS &WORKSHOPS WITH INSPECTORSOption 3 ( Data Integrity & IT Compliance Group): Data Integrity:Data Integrity in the GMP areaThis interactive session will offer the opportunity for the participants todiscuss current Data Integrity issues How to prepare for a Data Integrity inspection – the industry view Data Integrity Risk Assessment Data Integrity Inspection findingsOption 4 (GDP Group): How to Identify and Manage FalsifiedMedicines in the Supply ChainGet involved in the ECA Interest and Working Groups. Each delegate willbe invited to discuss the upcoming developments with the Chairs/members of the groups and EU inspectors.This workshop will offer the opportunity to discuss the following aspects: What is a suspected falsified medicine? How to identify falsified medicine in your workplace? How to approach the investigation of a suspected pack? What should the end user do with the pack? Routine monitoring of incoming goods Who should manage communication with the end users?AGENDAOption 5 (GDP Group): Risk Management in GDP WarehouseModeratored by: Dr Afshin Hosseiny / Dr Ulrich Kissel, Gert Moelgaard /Dr Rainer Gnibl, Dr Wolfgang Schumacher / Ib Alstrup, Dr ChristopherBurgess / N.N., Saddam Huq / Prabjeet DulaiYou can address topics of interest and you can provide feedback on thecurrently planned activities. It is the aim of the Interest and WorkingGroups to provide a platform for discussion with both colleagues fromindustry and regulatory y ControlGroupData Integrity & GDP GroupIT ComplianceGroupOption 1 (Validation Group): Qualification & Validation: Supplierintegration – how does this fit with GMP?This interactive session will offer the opportunity for the participants todiscuss some of new developments in qualification and validationactivities: How can qualification and GEP interact? How can suppliers be integrated? Categorisation of equipment – a tool for streamlining qualificationefforts Electronic qualification documentationOption 2 (Quality Control Group): QC: How sure are you that yourLaboratory Instrument/System is fit for its intended Purpose?1.2.3.Introduction to the ECA AQC Group Guideline on Analytical Instruments and Systems Qualification LifecycleOverview of USP General Chapter 1058 and revision of spectroscopic General Chapters USP 85x and 185x and their relationship to the newly proposed analytical procedure lifecycle in USP 1220 Reference standards for calibration and establishment of acceptancecriteria for ‘fitness for purpose’The risk-based approach is a fundamental requirement for processes inthe GDP environment. Risk management is one of the mandatory basicelements. It is applicable to a variety of activities and processes. Thisworkshop will cover challenges and possible solutions concerning riskmanagement in GDP warehouses. Different examples will be discussed.SESSIONInspections/Audits in Covid-19 TimesThe corona pandemic causes unusual supplier qualification activities.Meetings face-to-face are reduced or not possible at all. This concernssupplier audits but also regulatory inspections. To fulfil GMP-requirementsand to prevent travelling and meeting people personally is a balancing act.How to react?Distant Assessments – GMP-inspector s view Dr Rainer Gnibl, GMP Inspector Regulatory basis Requirements from guidelines Examples from inspections Reliability in “real life”Supplier Management during Covid-19 Pandemic Loretta Dougan, Jazz Pharmaeceuticals What is different than “normal” How to qualify suppliers during the pandemic? How to do reaudits from established suppliers? Remote audits as an alternative?GMP & GDP FORUM 2021 22-24 June 2021 Heidelberg, Germany & Live Online

PROGRAMME 24 JUNE – GDP PARTModerated by: Dr Afshin HosseinyIt is of key importance that medicinal products are not only made to a highquality in accordance with Good Manufacturing Practice (GMP), but thatthe quality and integrity of these products are maintained through theentire supply chain to the patient. This is where Good Distribution Practice(GDP) comes into play.On day 3, challenges and possible solutions will be discussed andexamples will demonstrate how the requirements can be put intopractice.GDP Responsibilities for Financial Trading Organisation Prabjeet Dulai, GDP & Quality Matters &Jonathan Riley, Astellas Pharma Europe Involvement of Marketing Authorisation Holders in the distributionnetwork The role of the Responsible Person when product handling is notinvolved Control of outsourced activities in integrated supply chains Processes used in financial distribution, and validation of computerisedsystemsSOCIAL EVENTGDP Update & OutlookDr Afshin Hosseiny, Chairman ECA Foundation and European GDP Association Major GDP developmentsCase Studies: When Things go Wrong – What can Happen in theReal World? Axel Radke, Trust Expertenservice First plan, then start Hand in hand for safe transport Basis of all considerations “Worst Case Scenario”Case Study: The Switch from Air-freight to Sea-Freight Saddam Huq, GlaxoSmithKline Challenges and Benefits ExamplesOn 22 June 2021, participants and speakers are invited to a social event,followed by a dinner, where the topics of the course can be furtherdiscussed in a relaxed atmosphere.SPECIAL OFFER WITH LUFTHANSA –DISCOUNTED TRAVELAs an ECA course or conferenceattendee, you will receive up to 20%discounted travel fares (according toavailability). And as LufthansaGerman Airlines offers a comprehensive global route network linkingmajor cities around the world you will most likely be able to benefit fromthese special prices and conditions.And this is how it works: Once you registered for a course or conferenceyou will receive a link together with your registration confirmation.Opening that link will take you to the Mobility Partner Program websitewhere you can enter a code in the “Access to Event Booking” area you willalso receive. This will take you into an online booking platform* that willautomatically calculate the discount offered or provide you with an evenbetter offer if another promotional fare is available.GDP Challenges in Africa Maria Sekamwa, Surgipharm Background Evolution of GDP over the years Problems involved Steps taken to improveCase Study: The Roche Quality Governance Model for Distribution to Direct Markets Jochen Heinzel, F. Hoffmann-La Roche Selection, implementation, operation and decommissioning of partners Key Performance Indicators (KPIs) Compliance score cardWe look forward to welcoming at one of our next events – and we alreadywish you a pleasant flight!*Please note: You may have to enable pop-ups on the Mobility PartnerProgram website – otherwise the booking platform window will not open.Master Data Cheryl Chia, Lotus Phoenix Consulting EU requirements Master Data framework for Medicines Impact to the Pharmaceutical Supply Chain QA/QP/RP oversight of the supply chainGMP & GDP FORUM 2021 22-24 June 2021 Heidelberg, Germany & Live Online

DateConference MaterialTuesday, 22 June 2021, 09.00 – approx. 17.30 h(Registration and coffee 08.30 – 09.00 h)Wednesday, 23 June 2021, 09.00 – approx. 17.00 h(Registration for new participants and coffee 08.30 – 09.00 h)Thursday, 24 June 2021, 09.00 – approx. 16.00 h(Registration for new participants and coffee 08.30 – 09.00 h)Important Information!Just prior to the conference you will get access to a download area whereyou will find the presentations as PDFs. Presentations will be uploaded upto the Conference as they become available. We hope for your understanding, though, if individual presentations are not available for download due to restrictions from the authors.All times mentioned are CEST.Please keep in mind that the conference materials will not be availableas print outs in a folder and there will be no on site opportunity to getpresentations printed.VenueHeidelberg Marriott HotelVangerowstrasse 1669115 HeidelbergPhone 49 (0)6221 – 908 0Fax 49 (0)6221 – 908 698Mail: info.heidelberg@marriott.comConference LanguageThe official conference language will be English.Organisation and ContactConference FeesECA members and European GDP Association members receive a200.- Euro discount.APIC members receive a 100.- Euro discount.EU GMP Inspectorates receive a 50% discount.Day 1 or day 2 or day 3: EUR 990.- per delegate plus VATDay 1 and 2: EUR 845.- per day and delegate (total 1690,-) plus VATDay 2 and 3: EUR 845.- per day and delegate (total 1690,-) plus VATDay 1-3 EUR 665.- per day and delegate (total 1990,-) plus VATThe conference fee is payable in advance after receipt of invoice andincludes conference documentation, dinner on the first day, lunch on alldays and all refreshments. VAT is reclaimable.AccommodationCONCEPT HEIDELBERG has reserved a limited number of rooms in theconference hotel. You will receive a room reservation form when you haveregistered for the event. Reservation should be made directly with thehotel not later than Early reservation is recommended.RegistrationYou can either register via the attached reservation form, by E-Mail or byfax, or you can register online at Yourregistration will be confirmed by E-Mail.PLEASE NOTE: You can register now and decide later howyou will participate – face-to-face in Heidelberg or remotelyat your screen.CONCEPT HEIDELBERGP.O. Box 10 17 6469007 Heidelberg, GermanyPhone 49 (0) 62 21/84 44-0Fax 49 (0) 62 21/84 44 34E-mail: eFor questions regarding content (GMP Part):Sven Pommeranz (Operations Director) at 49-62 21 / 84 44 47,or per e-mail at questions regarding content (GDP Part):Dr Markus Funk (Operations Director) at 49-62 21 / 84 44 40,or per e-mail at questions regarding reservation, hotel, organisation etc.:Mrs Nicole Bach (Organisation Manager) at 49-62 21 /84 44 22 or per e-mail at bach@concept-heidelberg.deAS A PARTICIPANT YOU WILL RECEIVE AN EXCLUSIVE PACKAGE OFNEW ECA GUIDELINE DOCUMENTSEach participant will receive a set of documents developed by ECAWorking and Inte

GMP & GDP FORUM 2021 22-24 June 2021 Heidelberg, Germany & Live Online EU GMP Annex 21: Import of Medicinal Products Dr. Ulrich Kissel, Chairman European QP Association e meaning of importation within scope of Annex 21 What is new in Annex 21 (dra )? What do we miss in Annex 21 (dra )? Conclusions and comments on the document

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