NEW: QP Forum App Qualifi ed Person Forum 2019 to install scan the code Munich, Germany, 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, Belgium 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 Bavaria, 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