24/25 April 2018, Düsseldorf/Neuss, Germany HIGHLIGHTS: This conference is part of the. Continuous Manufacturing

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Trends in SPEAKERS Manufacturing Continuous Manufacturing OSD Manufacture and Packaging GUNTHER BECHMANN Pfizer

ANDREAS HÄNEL R-Pharm Germany DR GERHARD JAS NICK LEE Health Product Regulatory Agency (HPRA), Ireland DR JEAN-DENIS

AFSSAPS DR ERIC MEIER Novartis YVES MICHON DR GIUSTINO DI PRETORO Johnson & Johnson DR THOMAS SCHWARZ Novartis DR

com Premium Sponsor: PHARMA CONGRESS Production & Technology 18 24/25 April 2018, Düsseldorf/Neuss, Germany

Dosage Manufacture and Packaging Containment und Exposure Limits for highly potent products High Containment

1 Trends in SPEAKERS Manufacturing Continuous Manufacturing OSD Manufacture and Packaging GUNTHER BECHMANN Pfizer MARTIN BERGEN securpharm DR LORENZO CAPRETTO GlaxoSmithKline, Great Britain DR RAINER GNIBL GMP-Inspector, Germany ANDREAS HÄNEL R-Pharm Germany DR GERHARD JAS NICK LEE Health Product Regulatory Agency (HPRA), Ireland DR JEAN-DENIS MALLET ECA & Former Head of the French Pharmaceutical Inspection Dpt. AFSSAPS DR ERIC MEIER Novartis YVES MICHON DR GIUSTINO DI PRETORO Johnson & Johnson DR THOMAS SCHWARZ Novartis DR HARALD STAHL GEA MICHAEL UNBEHAUN R-Pharm Germany This conference is part of the Premium Sponsor: PHARMA CONGRESS Production & Technology 18 24/25 April 2018, Düsseldorf/Neuss, Germany HIGHLIGHTS: Continuous Manufacturing Continuous Manufacturing from a Quality Perspective Regulatory aspects of continuous manufacturing? Case Study Janssen Pharmaceutica Case Study GSK Case Study Case Study Pfizer DÜSSELDORF, APRIL 2018 Oral Solid Dosage Manufacture and Packaging Containment und Exposure Limits for highly potent products High Containment Manufacturing at R-Pharm Germany: Fully Automated vs. Manual Processes Serialization in Europe & the current status of securpharm Serialization & Aggregation as a Contract Manufacturer The new Packaging Facility at Novartis Stein Global comparison of GMP requirements for OSD and Packaging Operations Image: GEA

Continuous Manufacturing 24 April 2018 Objectives It is the aim of this conference to show how a transition from batch to continuous manufacturing in the pharmaceutical industry can look like.

2 Continuous Manufacturing 24 April 2018 Objectives It is the aim of this conference to show how a transition from batch to continuous manufacturing in the pharmaceutical industry can look like. Questions regarding technology, process development and GMP/Quality Assurance will be discussed. Background Solid dosage forms are still the most common dosage form, first and foremost tablets without any pioneering developments in the recent years. But driven by only a few pharmaceutical companies more and more of the global players started to invest in continuous manufacturing. Companies like GSK, Pfizer, Johnson & Johnson and Vertex have been in the news lately. A shift from batch to continuous manufacturing could be one of the largest paradigm changes since the system of validation & qualification came up years ago. Regulating authorities, first of all the FDA, also encourage the transition from batch to continuous production. They expect an increase in product safety while equipment suppliers promote a decrease of production costs. But is this really the case? And, with a continuous mode of operation already answered questions raise again: What does a continuous line look like? How can batches be defined? What risks does a continuous process involve? How is a continuous system validated? How should deviations in a continuous process be handled? Listen to companies who already did the transition and learn about advantages / disadvantages and how they answered the questions above. Target Audience Moderator This conference is directed at decision makers and executives from the areas engineering, production and QA dealing with the question whether or how continuous manufacturing should be implemented. GÜNTER KÖRBLEIN, Tetragon Consulting Programme The new EU GMP Annex 1 consequences for industry: An EU GMP Inspector's view DR RAINER GNIBL GMP-Inspector for EMA and the district Upper Bavaria, Germany Continuous Manufacturing at Case Study GSK: Oral Solid Dose Continuous Manufacturing at GSK Our Continuous Manufacturing approach as a CDMO Key success factors for Continuous Manufacturing implementation Actual and future opportunities for CordenPharma clients YVES MICHON, Manufacturing vision and drivers for continuous manufacturing Technical and operational considerations in continuous manufacturing of tablets Adoption of continuous manufacturing in development Overcoming challenges and advancing the technology through pre-competitive and academic collaborations DR LORENZO CAPRETTO, GlaxoSmithKline

Continuous Manufacturing: drivers for change Critical elements & considerations when filing an MAA Regulatory guidelines and assistance in the EU NICK LEE, Health Products Regulatory Authority

3 Continuous Manufacturing: drivers for change Critical elements & considerations when filing an MAA Regulatory guidelines and assistance in the EU NICK LEE, Health Products Regulatory Authority (HPRA), Ireland Continuous Manufacturing from a Quality Perspective Continuous Manufacturing at J&J - our journey from batch to continuous Case Study Pfizer: Continuous Manufacturing Batch definition in continuous manufacturing Important GMP and Quality aspects to consider Control Strategy using PAT and automation State-of-control operation Batch Release DR ERIC MEIER, Novartis Our experience going from batch to CM the successful case of Prezista Vision and Strategy for Deployment of Continuous Manufacturing at Janssen Implementation of CM in development path forward and challenges DR GIUSTINO DI PRETORO, Johnson & Johnson Path forward by continuous manufacturing New opportunities going from batch to CM GUNTHER BECHMANN, Pfizer The Social Event at the Pharma Congress is already a tradition, and is networking and relaxation at the same time. On the evening of the first congress day, on 24 April 2018, all congress delegates and speakers are invited to a Get together in the Congress Center. Take advantage of this opportunity for an information exchange and enjoy the laid-back atmosphere and the entertainment programme. Oral Solid Dosage Manufacture and Packaging 25 April 2018 Objectives Background This conference focusses on current topics in secondary manufacturing. Handling of highly potent products and the implementation of track & trace systems play major roles here. Modern organization concepts of packaging facilities supplement this conference. Handling of Highly Potent Products is a subject that has been accompanying us for a while already. Yet, questions are still coming up also new questions. So, there are technical questions like How much Containment is needed? and, since recently, also questions regarding the relation between Containment and GMP. The background here is the European Medicines Agency s (EMA) concept, for the first time requiring substance-specific exposure limit values for all products with introducing the ADE/PDE limits. This leads to the question How much Cross Contamination is allowed? and to occupational medical care measurements being GMP relevant all of a sudden. Another subject is rather new. For introducing serialization and authentication systems the due date is now definitive in February This puts an enormous pressure on packaging operations in Europe. And it can only be managed if the operation has been preparing for quite some time already. However, not only pharma packaging operations have to be prepared, but also operators of superordinate server solutions as well as pharmacies. Another highlight is the new Novartis packaging plant for combination products. Optimisation and automation of processes are the key success factors here as well as in the new packaging and wholesaling centre of esparma Pharma. Target Audience Moderator This conference is directed at decision makers and executives from QA, engineering & production from packaging plants as well as persons responsible for the design and layout of containment systems and facilities. DR HARALD STAHL, GEA

4 Programme Corden as CDMO niche player chances and risks for going Conti DR GERHARD JAS Containment Fundamentals Case Study R-Pharm Germany: High Containment Manufacturing - Fully Automated vs. Manual and Flexible Processes Serialization in Europe & the current status of securpharm in Germany Case Study R-Pharm Germany: Serialization & Aggregation as a Contract Manufacturer How much containment is required? OEL, OEB, PDE How to define? How to identify the adequate technical solution? Exposure limits vs cleaning limits DR HARALD STAHL, GEA Four different Containment Facilities within one manufacturing site High automation concepts / Automation Layer Concept ISPE - Facility of the Year Award Winner 2008 New "Product and Process Development Centre" to handle Batch sizes of 0,5-20kg (manual vs. automated processes) ANDREAS HÄNEL, R-Pharm Germany Implementing the Falsified Medicines Directive State of play in Germany and Europe Reduction of misreadings Handling of misreadings in the pharmaceutical industry The required code quality Further timelines in Germany and Europe what comes February 2019? MARTIN BERGEN, securpharm Customer-oriented process design Serialization and Aggregation according to customer needs (integrated, combined or manual) Highly adaptable system infrastructure to fulfil all market standards Robust and flexible IT infrastructure MICHAEL UNBEHAUN, R-Pharm Germany Case Study Novartis: The new Packaging Facility at the Novartis Stein Site Recent and upcoming Challenges for Combination Products Regulatory requirements especially for ophtalmics The future product portfolio and its impact on the technical realisation Optimisation of the logistics: e.g. cool chain and tray/trolley handling Automation as basis for a competitive cost structure Challenges in the field of training and recruiting of human resources DR THOMAS SCHWARZ, Novartis Global GMP requirements for OSD & Packaging operations What s new (recently added guides)? What s different? (in US, Europe, China, India, JP ) What s state of the art DR JEAN-DENIS MALLET, ECA Advisory Board Member

5 Speakers GUNTHER BECHMANN, Pfizer Senior Manager Production Services. MARTIN BERGEN, securpharm Since 2012, Martin Bergen has been General Manager of securpharm e.v., the National Medicines Verification Organisation (NMVO) in Germany. The computer scientist is also engaged in pan-european projects such as the European Hub. Martin is a specialist for the implementation of new technologies in the healthcare business and coordination of the stakeholders involved. DR LORENZO CAPRETTO, GlaxoSmithKline Dr Capretto is responsible for the industrialisation of continuous manufacturing technologies. He is working at the interface of R&D and commercial to integrate novel technologies in the development portfolio. DR RAINER GNIBL, GMP-Inspector, Germany Dr Rainer Gnibl is pharmacist and GMP Inspector for the District Government of Upper Bavaria and the EMA and performs GMP-inspections worldwide. Before that, he was working for the Bavarian Ministry of Environment and Health. Rainer Gnibl also holds a lectureship at the University Erlangen- Nürnberg. ANDREAS HÄNEL, R-Pharm Germany Andreas Haenel is Head of Manufacturing Manager OSD and is responsible for solid dosage manufacturing at the R-Pharm Illertissen production site. He heads up a team consisting of specialists for conventional and high potent manufacturing. He started his career in Illertissen in 2000 within the Pfizer network. DR GERHARD JAS, R&D Management International. NICK LEE, Health Product Regulatory Agency (HPRA), Ireland Nick Lee is an Executive Pharmaceutical Assessor in the Health Products Regulatory Authority of Ireland where he is the department lead for Continuous Manufacturing. He is also the IE delegate to EMA s QWP and a member of the EMA PAT Team. Prior to joining the HPRA, Nick spent over 15 years in Industry in increasingly senior roles. DR ERIC MEIER, Novartis Dr. Eric J.M. Meier is Head QA Continuous Manufacturing at Novartis Pharma. Within global technical research and development quality assurance he is responsible for all quality aspects of continuous manufacturing, the GMP readiness and the implementation of the pharmaceutical quality system for a continuous manufacturing plant in Switzerland. He also is a lecturer the ETH Zürich for Medicinal and Industrial Pharmaceutical Sciences. DR JEAN-DENIS MALLET, ECA & Former Head of the French Pharmaceutical Inspection Dpt. AFSSAPS Dr Mallet was previously Head of the Pharmaceutical and Cosmetics Inspection Department at the French Health Products Regulatory Agency (Afssaps=ANSM). Now he is member of the ECA Advisory Board and works for NNE Pharmaplan. YVES MICHON, President, CordenPharma Chenôve. DR GIUSTINO DI PRETORO, Johnson & Johnson Giustino Di Pretoro is an Associate Director at Janssen Pharmaceutica, a Johnson & Johnson Company. Dr Di Pretoro is a subject matter expert and drug product development lead for continuous manufacturing, and coordinator for a series of academic collaborations within the field of continuous. DR THOMAS SCHWARZ, Novartis Dr Schwarz is Head Strategic Planning and PMO at the Novartis Stein Site for Steriles. He started his career 1999 at Hoechst in the Biotech Production. Since 2006 he is with Novartis in different Management Positions, e.g. Project Management, Production, QA and Development in USA and Switzerland. DR HARALD STAHL, GEA Dr Harald Stahl worked in the Pharmaceutical Development of Schering AG in Germany. Since 1995 he served within GEA Process Technology. Presently he owns the position of a Group Director Application & Strategy Management of GEA. He has published more than 20 papers on various aspects of pharmaceutical production. MICHAEL UNBEHAUN, R-Pharm Germany Michael Unbehaun is Manager Engineering Site Projects & Business Development and is responsible for the implementation of serialization and aggregation solutions at the R-Pharm Illertissen production site. He heads up a technical project team consisting of packaging, IT and automation specialists with the goal to implement customer-oriented and quality-assured track & trace process solutions. Until the end of 2013 he was part of the Pfizer Global Engineering Group and facilitating the T&T program roll-out on EU Pfizer locations.

6 Easy Registration Reservation Form: CONCEPT HEIDELBERG P.O. Box Heidelberg Germany Reservation Form: info@concept-heidelberg.de Internet: Date Tuesday, 24 April 2018, h Wednesday, 25 April 2018, h (Registration and coffee: Monday, 23 April 2018, h; Tuesday, 24 April 2018, h; Wednesday, 25 April 2018, h) Venue Crown Plaza (former Swissôtel) Düsseldorf / Neuss Rheinallee 1 D Neuss, Germany Phone: +49 (0) us.neu02@gchhotelgroup.com Fee EUR per delegate and day plus VAT (EUR 1.380,- for both days) (due to the special congress fees, ECA membership discounts are not applicable, and participation does not entail ECA membership). The conference fee is payable in advance after receipt of invoice and includes lunch on that day/both days, beverages during the event and during breaks as well as the Social Event on 24 April. VAT is reclaimable. Your registration also entitles you to participate in all other Pharma Congress conferences on either day of your registration. For the other conferences on both days please visit Registration Via the reservation form below, by or by fax message. Or you register online at If the bill-to-address deviates from the specification to the right, please fill out here: Reservation Form (Please complete in full) PLEASE NOTE Please note that there will not be any print-outs at the Congress. Instead you will receive all presentations prior to the Congress as Downloads. All Congress delegates (excluding exhibition visitors) will also receive the presentations on a USB stick at the registration centre. Please further note that there will be no room reservations via Concept Heidelberg. Please book your hotel room directly with the reservation form which you will receive together with your confirmation/invoice! Charges are payable after receipt of the invoice. Organisation & Contact ECA has entrusted Concept Heidelberg with the organisation of this event. CONCEPT HEIDELBERG P.O. Box D Heidelberg Phone +49 (0) 62 21/ Fax +49 (0) 62 21/ info@concept-heidelberg.de For questions regarding content: Dr Robert Eicher (Operations Director) at / , or per at eicher@concept-heidelberg.de. For questions regarding reservation, hotel, organisation etc.: Mr Ronny Strohwald (Organisation Manager) at / , or per at strohwald@concept-heidelberg.de. Trends in Manufacturing (24-25 April 2018) Part of the Pharma Congress Production & Technology 2018 Düsseldorf/Neuss, Germany, April 2018 I register for: Continuous Manufacturing (24 April 2018) OSD Manufacture & Packaging (25 April 2018) Both days (24-25 April ,- ) PLEASE NOTE: Please book your hotel room directly with the reservation form which you will receive together with your confirmation/ invoice! Yes, I would also like to participate in the Social Event on 24 April * Mr * Ms Title, first name, surname CONCEPT HEIDELBERG P.O. Box Fax +49 (0) 6221/ Heidelberg Germany Company Department Important: Please indicate your company s VAT ID Number Please indicate the Purchase Order Number, if applicable Street / P.O. Box City Zip Code Country Phone / Fax (Please fill in) General terms and conditions If 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 %, until 1 weeks prior to the conference 50 % 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 full refund of fees paid. CONCEPT HEIDELBERG will not be responsible for discount airfare penalties or other 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 non-appearance. If you cannot take part, you have to inform us in writing. The cancellation fee will then be 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 full registration fee, even if you have not made the payment yet. Only after we have received your payment, you are entitled to participate in the conference (receipt of payment will not be confirmed)! Privacy Policy: By registering for this event, I accept the processing of my Personal Data. CONCEPT HEIDELBERG will use my data for the processing of this order, for which I hereby declare to agree that my personal data is stored and processed. CONCEPT HEIDELBERG will only send me information in relation with this order or similar ones. 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