NEW: QP Forum App Qualifi ed Person Forum 2019 to install scan the code Munich, , 28-29 November 2019 Pre-Conference Sessions 27 November 2019: Specifi c Requirements for Investigational Medicinal Products (full day) New QPs meet experienced QPs (1/2 day) Serialisation revisited (1/2 DAY)

Speakers from Authorities, Speakers from Industry: Inspectorates and Associations: Steven De Strycker Justin Barry Dr Afshin Hosseiny Dr Andreas Schwinn Federal Agency for Medicines and Health Emergex Vaccines ECA Roche Pharma Products, fagg, Anthony Bennett Patryk Jegorow Kasper Buchwald Sønderskov Silja Du Mont Anthony Inspires Takeda Novo Nordisk GCP/GDP Inspector, Germany Richard M. Bonner Dr Ulrich Kissel Niina Taylor Klaus Eichmüller former Chairman of the EQPA EQPA P zer Wolnzach, c/o Regional Competent David Cockburn Line Lundsberg-Nielsen Brenda Van Assche Authority, Germany EQPA Lundsberg Consulting Janssen Dr Rainer Gnibl Dr Susanne Ding Aidan Madden Philippe Van der Hofstadt Government of Upper , Germany Boehringer Ingelheim FivePharma Clinical Supplies Management Mag.pharm. Andreas Kraßnigg Walid El Azab Sue Mann Dr Anke von Harpe Austrian Agency for Health and Food Safety Steris Sue Mann Consultancy QProgress (AGES) DI Georg Göstl Edel Ryan Peter C. Zimmermann Gillian Renouf Takeda Mylan Iskom Royal Pharmaceutical Society QP Tor Gråberg Assessment Panel, U.K. AstraZeneca QP Welcome

Dear Colleagues, The QP is responsible for ensuring that each individual batch has been manufactured and checked in accordance with the require- ments of the marketing authorisation (MA) and in compliance with GMP. This is how it is described in Annex 16 of the EU-GMP Guidelines. The Annex also describes in detail other QP’s responsi- bilities and activities in part 1.7.

But the QP is not responsible for everything! Most activities may be delegated and the QP can rely on the respective Pharmaceuti- cal Quality System. How this can be done will be a central topic of this year’s QP Forum.

Don’t forget: “The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and effi cacy, lies with the marketing authorisation holder (MAH).”

Make use of this event by exchanging experiences with your colleagues and by establishing informal contacts and networking. I look forward to meeting you in Munich.

Best regards,

Dr Ulrich Kissel Chairman of the Qualifi ed Person Association Objective

This Conference is designed by QPs for QPs as an international Expert Forum with focus on sharing information and experience and on discussing the challenging parts of the QP’s daily work.

Target Group

The Forum is designed for all Qualifi ed Persons and aspiring Qualifi ed Persons. It also addresses upper management functions and authority representatives who want to be informed about the latest development regarding the duties and responsibilities of Qualifi ed Persons.

Forum Moderator

Aidan Madden

Important Information! The presentations of the QP Forum and the Pre-Conference Workshop/ Session will be available for download and your print-out one week before and after the conference.

NEW: QP Forum App Just download the new QP Forum app to your smartphone or tablet and have everything at hand: agenda, presentations, speaker backgrounds, notifi cations and more... To install the app, please scan the QR code or search for “Pharma Events” in the Apple or the Google Play Store.

Note: there will be no print-outs available during the conference. Pre-Conference Sessions Programme QP Forum

27 November 2019 28-29 November 2019 Full Day Pre-Conference Session Key Note: A Patient’s View - What Dying taught me about Living Specifi c Requirements for IMPs Anthony Bennett Facilitated by: After surviving multiple viral infections with a 10% survival rate, Anthony Justin Barry / Susanne Ding / Silja Du Mont / Rainer Gnibl / brings to light the importance of teamwork, from the perspective of his Patryk Jegorow / Andreas Schwinn / Niina Taylor / Brenda Van Assche / family and the medical professionals during his time in hospital. After Philippe Van der Hofstadt listening to this session QPs should feel inspired, uplifted and proud of the work they do.  New legislation impacting IMP QPs  Looking to the future: Experiences made with the MRA and post-Brexit – Continuous manufacturing Tor Gråberg – Virtual clinical trials  Diffi culties and how to overcome (inspections, GMP certifi cates, – Direct to patient shipment importation)  Interactive sessions and case studies – decision making of IMP QPs  What we have experienced  An inspector’s view on the GMP/GCP/GDP interface  Problems occurred and solutions found  Template for a manufacturer – sponsor agreement  Q&A sessions GMP Update Session David Cockburn, Rainer Gnibl and Tor Gråberg  New Regulations and Guidance and their relevance for the QP 1/2 Day Pre-Conference Session What the QP needs to know about the current New QPs meet experienced QPs Contamination Control Strategy Facilitated by: Walid El Azab Richard M. Bonner / Georg Göstl / Andreas Kraßnigg / Sue Mann  Development of a risk-based assessment for contamination control and sterility assurance maintenance A tailor-made session for new and aspiring QPs with round-table  What the QP should be aware of before certifying products discussions and lots of interaction. Discuss your questions and worries  Where the involvement of the QP is needed with experienced QPs and a GMP Inspector.  Information fl ow

Real Time Release Testing and Certifi cation by the QP: a next 1/2 Day Pre-Conference Session Generation Process or still Phantasm? Line Lundsberg-Nielsen Serialisation revisited  What the QP needs to know about Annex 17, ICH Q12 and Real Time Facilitated by: Release concepts Steven De Strycker / Afshin Hosseiny / Ulrich Kissel  What is already possible – and what not  Pre-requisites, chances and challenges Nine months after implementation: Discuss challenges in the market and  What do authorities expect? the impact on the QP’s daily life and fi nd answers and solutions. The PQR and its benefi t for the QP Klaus Eichmüller  How the PQR could be used in an effi cient way and not end in a graveyard of data Qualifi ed Person Forum 2019 • Munich, Germany • 28-29 November 2019 Parallel Sessions Q&A Session

Working on Case Studies During the 2 days of the Forum, delegates can post their questions. The answers will be given by the expert speakers in a dedicated session and/ 1) Soft Skills for QPs or published in the members’ area of the EQPA website.  How to analyse communication situations  How to deescalate confl ict situations  How to show self-confi dence in discussions with senior manage- Social Event ment? Richard Bonner and Peter C. Zimmermann

2) Change Control and Certifi cation for global Markets  How to deal with change control challenges when regular approvals can take several months or years to cover all the relevant countries worldwide  How to support decision making Ulrich Kissel and Kasper Buchwald Sønderskov

3) QP Scenarios – How serious could each issue be?  Discuss real-life situations involving QPs  Explore the potential risks and impact  Make decisions on the product(s) involved Sue Mann and Gillian Renouf On 28 November, you are cordially invited to a Bavarian Evening. This is an excellent opportunity to share your experiences with colleagues from 4) Challenges for IMP QPs other companies in a relaxed atmosphere.  Sample and documentation retention, etc.  Experience sharing, e.g. Brexit, new IMP GMP regulation  Challenges for smaller companies Special Off er with Lufthansa – IMP Working Group Discounted Travel As an ECA course or conference attendee, 5) QP Oversight you will receive up to 20% discounted travel  Practical aspects of keeping oversight on both external (third party) fares (according to availability). And as Lufthansa German Airlines off ers a and internal (own site/ own company) QP-related processes comprehensive global route network linking major cities around the  QP responsibilities and delegation of tasks world you will most likely be able to benefi t from these special prices Edel Ryan and Anke von Harpe and conditions.

6) The QP in the Pharmaceutical Quality System And this is how it works: Once you registered for a course or conference  Discuss how the QP can rely on a PQS and how such a system could you will receive a link together with your registration confi rmation. be set up Opening that link will take you to the Mobility Partner Program website  Assistance and support for the QP where you can enter a code in the “Access to Event Booking” area you will Afshin Hosseiny and Aidan Madden also receive. This will take you into an online booking platform that will automatically calculate the discount off ered or provide you with an even You will be able to attend three of these parallel sessions. better off er if another promotional fare is available. Please choose the ones you like to attend when you register for the Forum.

Qualifi ed Person Forum 2019 • Munich, Germany • 28-29 November 2019 Speakers

Speakers from Authorities, Inspectorates and Associations:

Steven De Strycker, Federal Agency for Medicines and Health Products, Tor Gråberg, AstraZeneca, Sweden fagg, Belgium Head of External Advocacy, Global Quality, Operations, and member of GMP Inspector the EQPA Board of Directors. Former Head of the Drug Inspectorate at the Swedish Medical Products Agency and former PIC/S Chair Silja Du Mont, GCP/GDP Inspector, District Authority of Freiburg, Germany GCP/GDP Inspector, Head of the German GCP Inspectors Expert Group Dr Afshin Hosseiny, Tabriz Consulting, U.K. and European Expert GCP IWG EMA Managing Director and Qualifi ed Person, Chair of the ECA Executive Board and Chair of the European GDP Association Klaus Eichmüller, Wolnzach, c/o Regional Competent Authority, Germany Head of the Inspectorate for Drug Products, APIs, Blood Products and Patryk Jegorow, Takeda, Ireland Tissues in Hesse Qualifi ed Person Biologics, Head of Quality Strategy and Businees Operations Dr Rainer Gnibl, Government of , Germany GMP Inspector for the District Government and the EMA, Advisory Board Dr Ulrich Kissel, European Quali ed Person Association (EQPA) member of the Qualifi ed Person Association Qualifi ed Person and Chairman of the EQPA Board of Directors

Mag.pharm. Andreas Kraßnigg, Austrian Agency for Health and Food Line Lundsberg-Nielsen, Lundsberg Consulting Ltd, U.K. Safety (AGES), Austria Founder and Owner Head Pharmaceutical Inspections and Member of Annex 16 Drafting Group Aidan Madden, FivePharma, Ireland CEO Gillian Renouf, Royal Pharmaceutical Society QP Assessment Panel, U.K. Chair of the RPS QP Assessment Panel Sue Mann, Sue Mann Consultancy Ltd. U.K. Qualifi ed Person and QP Assessor working on behalf of the MHRA, representing the Royal Pharmaceutical Society Speakers from Industry: Edel Ryan, Mylan, Ireland Justin Barry, Emergex Vaccines, U.K. Director Complex Products Quality Operations Head of Global Manufacturing and member of the EQPA IMP Working Group Board Dr Andreas Schwinn, Roche Pharma AG, Germany Anthony Bennett, Anthony Inspires Ltd., U.K. Head PQIP, Qualifi ed Person Inspirational Speaker Kasper Buchwald Sønderskov, Novo Nordisk A/S, Denmark Richard M. Bonner, U.K. Director Quality Assurance and Qualifi ed Person Former Chairman of the EQPA Board of Directors and former Chair of the ECA Executive Board Niina Taylor, P zer, U.K. Director Quality Assurance and Qualifi ed Person David Cockburn, European Quali ed Person Association (EQPA) Member of the EQPA Board of Directors. Former Chair of the EMA GMP/ Brenda Van Assche, Janssen Pharmaceutica NV, Belgium GDP IWG Director Quality Assurance Clinical Supply Chain and Qualifi ed Person

Dr Susanne Ding, Boehringer Ingelheim, Germany Philippe Van der Hofstadt, Clinical Supplies Management, Belgium Qualifi ed Person for Investigational Medicinal Products and member of VP Corporate Development the EQPA Board of Directors Dr Anke von Harpe, QProgress, Germany Walid El Azab, Steris N.V./S.A., Belgium Qualifi ed Person and Pharmaceutical Consultant Technical Services Manager and former QP Peter C. Zimmermann, Iskom, Germany DI Georg Göstl, Takeda, Austria CEO Qualifi ed Person, Chair of the Austrian QP Association aqpa and member of the EQPA Board of Directors If the bill-to-address deviates from the specification to the Reservation Form (Please complete in full) right, please fill out here: * Qualified Person Forum 2019, Munich, Germany, 28-29 November 2019 Please choose three of the six parallel sessions: * Session 1: Soft skills for QPs * Session 2: Change Control and Certification for global Markets * Session 3: QP Scenarios – How serious could each issue be? * Session 4: Challenges for IMP QPs * Session 5: QP Oversight * Session 6: The QP in the Pharmaceutical Quality System

* Optional Pre-Conference Session, Munich, Germany, 27 November 2019 Please choose one of the following: * Full Day Session “Specific Requirements for IMPs” * 1/2 Day Session “New QPs meet experienced QPs” * 1/2 Day Session “Serialisation revisited” * Mr * Ms

Title, first name, surname CONCEPT HEIDELBERG Postfach 10 17 64 Company Department Fax 06221/84 44 34 Important: Please indicate your company’s VAT ID Number D-69007 Heidelberg P.O Number (if applicable)

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E-mail ( Please fill in)  CONCEPT with theorganisation HEIDELBERG ofits events. HEIDELBERG. The European QPAssociation hasentrusted year more than 300events willbeorganised by CONCEPT control,quality assurance andGMPinEurope. quality This organiser production, ofseminarsonpharmaceutical Founded in1978,CONCEPT istheleading HEIDELBERG About CONCEPT HEIDELBERG www.qp-association.eu. membership application form are available at More information abouttheQPAssociation anda Europeanharmonised approach. a and address difficulties andchallenges to support ence, requirements, discussthelatest regulatory to identify with aplatform allowing them to exchange- theirexperi unique associationtheECAwantsto provide QPs inEurope Academy’s Board Members. (ECA)Advisory With this founded on7July2006 by theEuropean Compliance The European Qualified Person (QP) Association was About the European QPAssociation payment (receipt ofpayment willnotbeconfirmed)! intheconferenceparticipate untilwe have received your have notmadethepayment yet. You are not entitledto us, you willhave to pay thefullregistration fee even ifyou you donotappearattheevent withouthaving informed point oftimeatwhichwe receive your case message. In cancellation fee willthenbecalculated according to the you have to part, inform usinwriting.cannot take The are you dueincaseofcancellationornon-appearance. If This isabindingregistration andaboveImportant: fees days receipt after ofinvoice. Terms ofpayment: Payable within10 withoutdeductions tion. penaltiesorothercostsincurred dueto acancella- airfare CONCEPT willnotberesponsible HEIDELBERG for discount refund offees paid. will benotifiedassoonpossibleand receive afull theevent mustbecancelled,cancel anevent. If registrants materials, withoutnoticeorto instructors, orspeakers to changethe theright CONCEPT reserves HEIDELBERG • • • following processing fees: Cancellation you have2. If to cancelentirely, we mustcharge the time. 1. We are happy to welcome asubstitute colleagueatany you cannotattend theconferenceIf you have options: two General Terms ofBusiness registration fee. within 1weekto theconference prior 100%ofthe registration fee. until 1week to the conference prior 50%ofthe registration fee. until 2weeks to theconference prior 10%ofthe

wh/05082019 Date Full Day Pre-Conference Session: Fees for ½ Day Pre-Conference Session: Specifi c Requirements for IMPs Serialisation revisited Wednesday, 27 November 2019, 9.00 – 18.00 € 590,- per delegate plus VAT. (Registration and coff ee: 8.30 – 9.00) The fee is payable in advance after receipt of invoice and includes electronic conference documentation, welcome reception and all Date ½ Day Pre-Conference Session: refreshments. VAT is reclaimable. New QPs meet experienced QPs Wednesday, 27 November 2019, 13.30 – 18.00 Accommodation (Registration, snacks and coff ee: 13.00 – 13.30) CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation link for the Sofi tel Date ½ Day Pre-Conference Session: and other hotels close by when you have registered for the conference. Serialisation revisited Reservation should be made directly with the hotel of your choice with Wednesday, 27 November 2019, 13.00 – 18.00 one of the reservation links. Early reservation is recommended. (Registration, snacks and coff ee: 12.30 – 13.00) Saving opportunities: Welcome Reception for all participants Wednesday, 27 November 2019, 18.00 – 19.00 Book both the QP Forum and a Pre-Conference Session: Delegates who attend the QP Forum and a Pre-Conference Session will get a Date QP Forum discount of 200€ on the QP Forum. Thursday, 28 November 2019, 9.00 – 18.00 (Registration: Wednesday, 27 November 18.00 – 19.00 and Thursday, 28 November, 08.00 – 9.00) Registration Friday, 29 November 2019, 8.30 – 14.30 Via the attached reservation form, by e-mail to [email protected] or by fax to +49 6221 / 84 44 34 . Or you register online at Venue www.qp-forum.org. Sofi tel Munich Bayerpost Bayerstrasse 12 Conference Language 80335 Munich The offi cial conference language will be English. Germany Tel.: +49 (0)89 599 48 0 Organisation / Contact E-mail: H5413@sofi tel.com CONCEPT HEIDELBERG P.O. Box 10 17 64 Fees for QP Forum D-69007 Heidelberg, Germany QP Association Members € 1.690,- per delegate plus VAT. Phone +49 (0) 62 21/84 44-0 EU GMP Inspectorates € 895,- per delegate plus VAT. Fax +49 (0) 62 21/84 44 34 Non-QP Association Members € 1.890,- per delegate plus VAT. E-mail: [email protected] The conference fee is payable in advance after receipt of invoice and www.concept-heidelberg.de includes electronic conference documentation, welcome reception, dinner on the fi rst day, lunch on both days and all refreshments. VAT is For questions regarding content: reclaimable. Mr Wolfgang Schmitt (Operations Director) at +49-62 21 / 84 44 39, or per e-mail at [email protected]. Fees for Full Day Pre-Conference Session: For questions regarding reservation, hotel, organisation etc: Specifi c Requirements for IMPs Ms Marion Grimm (Organisation Manager) at +49 (0) 62 21 / 84 44 18, € 990,- per delegate plus VAT. or per e-mail at [email protected]. The fee is payable in advance after receipt of invoice and includes electronic conference documentation, welcome reception, lunch and all refreshments. VAT is reclaimable.

Fees for ½ Day Pre-Conference Session: New QPs meet experienced QPs € 590,- per delegate plus VAT. The fee is payable in advance after receipt of invoice and includes electronic conference documentation, welcome reception and all refreshments. VAT is reclaimable.