Berlin, Germany | June 8 - 9, 2017

Regulatory updates for packaging operationsIncreasing packaging productivity and qualityContainer Closure Integrity (CCI) testing technologiesMaterials and components characterisationSet-up of a robust inline inspection systemControl packaging materialProduct distribution and storageImplementing serialisation

Roman MathaesPrincipal Scientist Senior Group Leader Lonza, Switzerland

Tino OtteSenior Scientific Consultant Intertek, Germany

Mike TateHuman Factors ManagerBoehringer Ingelheim, Germany

Stefan SchelerSenior scientist in Primary Packaging Development for BiosimilarsNovartis

Dr. Lothar HabelStudy DirectorToxikon Europe, Belgium

Philippe Lauwers Business Unit Director PharmaPackaging Nipro EUrope NV, Belgium

Dieter MößnerProject Engineer PharmaEdelmann GmbH, Germany

Bram JongenHead of Material Development, Container Closures & Injection SystemsDATWYLER Sealing Solutions, Belgium

Michele ArduiniSales & Marketing Director IMA Life - IMA Group, Italy

Andrea SimonettiDirector of Sales and MarketingConvel Srl, Italy

Oliver Valet Managing Director rap.ID Particle Systems, Germany

Thomas PackScientific Director, Primary Container and Device Delivery Systems, Pharmaceutical DevelopmentJanssen Research & Development LLC, USA

Key Speakers:

Key Practical Learning Points of the Summit:

The event is co-located with:Annual Extractables & Leachables Summit

Hotel Riu Plaza Berlin | Martin-Luther-Strasse 1 | 10777 Berlin, Germany

Exhibit Sponsor:

Berlin, GermanyJune 8 - 9, 2017

Company type in %

Pharmaceutical

Biotechnology

Medical Devices

CMO

CRO

NOP

Other

Geographic distribution in %

Europe

United States

Canada

APAC

Other

e are pleased to invite you to the ‘Packaging for Par-enterals Summit’ scheduled for 8th and 9th of June 2017, in Berlin, Germany.

This premier event rovides the appropriate platform to dis-cuss and network with peers involved in parenteral manufac-turing, packaging, quality control, container development and regulatory affairs.

The summit will shed light on regulatory updates, CCI testing, variety of materials and their characteristics, drug stability, pri-mary and secondary packaging.

It is an honour and privilege to invite you to participate in this Summit. We look forward to welcoming you at the Summit in Berlin this coming June!

About UsVonlanthen Group of Companies is made for innovative and se-nior business leaders focused on confronting challenges and seiz-ing opportunities. We conduct extensive research and connect deal-makers and risk-takers across Europe and emerging mar-kets to help propel companies to the next level. Our conferences, events and training schemes are designed for senior decision-makers working at the top of their industries with cutting-edge strategies, products, processes and technologies. Vonlanthen Group of Companies is the natural home for compa-nies always on the lookout for opportunities, always searching for the next deal, and always with an eye on the competition.

Who Should Attend:Chief Executives, Directors, Vice Presidents, Department Heads, Laboratory Heads, Leaders, Senior Managers, Formulation Scientists specialising in:

Container developmentControls & RoboticsComplianceDrug DevelopmentLabellingMaterials Science & SelectionManufacturing Science & TechnologyMedical DevicesParenteralsPackaging Product & Process DevelopmentQA/QCRisk managementRegulatory AffairsSafety AssessmentsStandardisationSupply Chain Technical Support

Registration and Welcome CoffeeOpening Address from the Chairman

09:10 CASE STUDY

Consideration of primary container design and interaction with biologics, devices, and the patient

10:30 CASE STUDY

Human factors considerations in the design of medical device packaging

REGULATORY REQUIREMENTS AND UPDATES

1 2

11:40 CASE STUDY

Requirements and Concepts for Secondary Packaging for Syringes, Vials and Ampoules

DIETER MÖSSNERProject Engineer PharmaEdelmann GmbH

DR. LOTHAR HABELStudy DirectorToxikon Europe

MIKE TATEHuman Factors ManagerBoehringer Ingelheim

08:3009:00

SPEED NETWORKING09:50An innovative approach to maximize networking capabilities through two minute periods, where delegates can meet their peers and exchange business cards before rotating to the next company representative.

Day OneJune 8, 2017

BUSINESS LUNCH13:00

MORNING COFFEE AND NETWORKING BREAK11:10

12:20 CASE STUDY

A practical guide to extractables and leachables testing with a special focus on parenteral applications:

ANALYTICAL CHARACTERIZATION

STEFAN SCHELERSenior scientist in Primary Packaging Development for BiosimilarsNovartis

A pharmaceutical matrix from the viewpoint of an analyst From relevant target compounds to the appropriate analytical methods Between a simplified study setup and a sophisticated approach Screenings and validated methods – pros and cons

Human factors in medical devices The Usability Engineering process Regulatory guidance and standards Human factors testing for safety and efficacy

SECONDARY PACKAGING REGULATORY REQUIREMENTS

When to consider secondary packaging during development process Market trends relating to secondary packaging for parenteral drugs General requirements for secondary packaging concepts for syringes, ampoules and vials, When to consider secondary packaging during development process? Standard folding boxes for ampoules, vials, syringes, Excursion: Packaging requirements dental drugs – prefilled syringes Automated tamper evident boxes for ampoules, Packaging development – one component instead of two Conclusions / recommendations for the practice

16:20

CHAIRMAN’S CLOSING REMARKS AND END OF DAY ONE17:40

AFTERNOON COFFEE AND NETWORKING BREAK15:50

14:40

CASE STUDY

CASE STUDY

Risk management: the industry perspective

17:00 PANEL DISCUSSION

BUSINESS DINNER18:30

14:00 CASE STUDY

To be announced

Rubber stopper formulation developments throughout the years:

OLIVER VALET Managing Director rap.ID Particle Systems

BRAM JONGENHead of Material Development, Container Closures & Injection SystemsDATWYLER Sealing Solutions

1 2

Increasing material choices will involvement of newer polymers

15:20 WORKSHOP SESSION

Opportunity available for sponsored presentation

With Speakers of the DayModerated by the Chairman

Day OneJune 8, 2017

Strategies to reduce testing Real examples Lessons learned

Glass delamination studies for pharmaceutical vials – a general strategy

TINO OTTESenior Scientific Consultant Intertek

General risks to production and patient safety Factors contributing to glass delamination Analytical assessment for minimizing the risk - with examples

MATERIALS CHARACTERISATION

Overview of the typical ingredients and chemical composition of rubber formulations intended for parenteral applications, Different rubber formulations geared towards specific applications Ongoing developments in rubber formulation How to select the right rubber formulation for a parenteral application

Registration and Welcome CoffeeOpening Address from the Chairman of Day2

09:0009:40

09:50 CASE STUDY

Innovative production and inspection technologies in the manufacturing process of glass pre-fillable syringes

10:30 CASE STUDY

Optimisation of container filling lines

PROCESS INNOVATIONS

MORNING COFFEE AND NETWORKING BREAK11:10

PHILIPPE LAUWERS Business Unit Director PharmaPackaging Nipro EUrope NV

MICHELE ARDUINISales & Marketing Director IMA Life - IMA Group

BUSINESS LUNCH12:50

12:10 CASE STUDY

Container Closure Integrity for Frozen Drug Products

ROMAN MATHAESPrincipal Scientist Senior Group Leader Lonza, Switzerland

1 2

Advanced aseptic packaging in one operations cycle

11:40 WORKSHOP SESSION

Open opportunity for sponsors

Day TwoJune 9, 2017

Introduction of a laser-assisted glass cutting technology Resulting in reduced glass particle count, mechanically stronger and dimensionally more stable finger flanges Features and benefits of an innovative X-ray inspection unit Addressing increasing regulatory requirements for CCI and for drug delivery systems safety

CONTAINER CLOSURE INTEGRITY

Container Closure Integrity Introduction Latest Regulatory Changes – USP <1207> Revision Container Closure Integrity for Frozen Drug Products Container Closure Integrity Strategy: Holistic Approach

Regulatory updates: Where are we here? What’s next?

15:40

CHAIRMAN’S CLOSING REMARKS AND END OF SUMMIT16:40

PANEL DISCUSSION

CASE STUDY14:00

What We DoVonlanthen Group of Companies is the premier forum for deal-makers and business leaders. We help industry experts and investors find the next opportunity, strike the next deal and enter growing markets by:• Hosting summits, conferences and workshops for senior decision makers, with a focus on sharing practical advice and experience to source opportunities and confront challenges• Putting top executives together to share insights on the outlook for their industry in our cutting edge leadership forums• Helping businesses - large and small - fund investment and growth by arranging capital-raising meetings• Conducting bespoke executive training courses to ensure management teams are operating at the highest possible levelEverybody who attends a Vonlanthen Group event has been pre-screened to ensure the highest quality of delegates and to kick-start the deal-making process.

CASE STUDY

New developments in non destructive Container Closure Integrity for Parenteral products

ANDREA SIMONETTIHead of Sales and MarketingConvel Srl

AFTERNOON COFFEE AND NETWORKING BREAK16:10

1 2

With Speakers of the DayModerated by the Chairman

Day TwoJune 9, 2017

14:40

Pharmacoepial and GMP guidance Main compliance issues Latest regulatory trends

Container Closure Integrity Issues of Rubber Stoppered Plastic Vials Stored under Cryogenic Conditions

THOMAS PACKScientific Director, Primary Container and Device Delivery Systems, Pharmaceutical DevelopmentJanssen Research & Development LLC

Issues and concerns with developing a primary container stored under cryogenic conditions Techniques you can use to evaluate the packages container closure integrity during and after long term cryo storage? Learnings to help you avoid pitfalls placing you on the critical path to product approval?

Leak detection methods for parental packages HVLD technology outline Case study: products with different level of conductivity, opportunities and challenges HVLD technology improvement with double measurement Lessons learned

1 2Speakers Biographies

Thomas Pack is Scientific Director, Primary Container and Device Delivery Systems, Pharmaceutical Development, Janssen R&D, LLC. He earned his Bachelor of Science degree from the Rochester Institute of Technol-ogy and a Masters of Business Administration in Manufacturing Manage-ment from the Rensselaer Polytechnic Institute, Rensselaer, New York. Thomas has spent over 30 years’ developing primary container systems for all pharmaceutical dosage forms with a special interest in injectable products. His organization is currently evaluating the impact of cryogenic storage conditions on the performance of polymers and elastomers as they pass the glass transition phase. He is the former Chairman of the Drug & Pharmaceutical Packaging Committee; a technical organization under the Institute of Packaging Professionals comprised of research based pharmaceutical firms in the US.

Roman Mathaes is a group leader within the Lonza Drug Product Service organization. He is leading the Lonza particle lab and the container clo-sure integrity testing. In this role, Roman is responsible for particle ana-lytics in drug products and container closure integrity testing of vials and pre-filled syringes and process development of capping/crimping. Prior to this assignment, Roman was working within Roche/Genentech net-work supporting process development of the commercial manufacturing. Roman is an active member of the European CCI industry focus group and part of the BPOG CCI workstream. Roman is a pharmacist by train-ing and conducted his studies at the University of Marburg and King’s College London. He holds a PhD in pharmaceutical technology from the University of Munich for work on subvisible particle characterization.

Since 20 years, Dieter Mößner has been working at Edelmann as a tech-nical project manager. He leads projects in Braille application, seriali-sation, tamper verification and anti-counterfeiting of pharma and con-sumer good packaging and consults customers and artwork agencies in artwork creation, print data communication and typesetting workflows. He is Convenor of CEN/TC 261/SC 5/WG 12 “Marking”. This working group at the European committee for standardisation CEN has created the European standard EN 15823:2010 “Braille on packaging for medici-nal products and EN 16679:2015 – the European standard on “Tamper verification features for medicinal product packaging”. Dieter Mößner is a Chairman of the German working groups NA 115-03-01 AA “Braille on packaging” and “Tamper verification features for medicinal product packaging”. After six years being the Vice-chairman of the packaging standards committee NAVp at the German Standards Institute DIN he became its Chairman in March 2013.

Lothar Habel is working as Study Director for Extractables and Leach-ables projects at Toxikon Europe, with a strong focus on parenterals and injectable applications. After his Ph.D. graduation in organic chemistry at the University of Frankfurt am Main (Germany), he spent several years with research projects at universities and private companies in Germany and Belgium where he gained his expertise in preparative and analytical organic chemistry. In 2006, he joined Toxikon Europe, a CRO located in Leuven (Belgium) with a high reputation and expertise in the field of E&L.

Philippe Lauwers is Business Unit Director Pre-Filled Syringes at NiproPharmaPackaging (NPP); a division of Nipro Corporation. NPP is a global,vertically integrated primary packaging manufacturer with a broad prod-uct portfolio and knowledge, giving unparalleled industry know-how andexpertise. Mr. Lauwers graduated in Biotechnology from the University in Ghent, Belgium and worked as a scientific researcher at the Catholic University of Leuven. Upon obtaining an additional degree in BiomedicalEngineering at the Catholic University of Leuven he moved from an aca-demic to an industrial environment. He has been active in the Medical and Pharma packaging sector for the last 10 years in various roles. He joined Nipro PharmaPackaging in January 2016 and is involved in tech-nical and scientific discussions with customers, as well as in scientific marketing and business development activities.

Thomas PackScientific Director, Primary Container and Device Delivery Systems, Pharmaceutical DevelopmentJanssen Research & Development LLC, USA

Roman MathaesPrincipal Scientist Senior Group Leader Lonza, Switzerland

Philippe Lauwers Business Unit Director PFS PharmaPackaging Nipro EUrope NV, Belgium

Dieter MößnerProject Engineer PharmaEdelmann GmbH Heidenheim,Germany

Dr. Lothar HabelStudy DirectorToxikon Europe, Belgium

After his Masters in Polymer Chemistry at the University of Louvain, Bel-gium, Bram Jongen acquired a Ph.D. in Water Soluble Polymers used for advanced drug administration. Bram started as Technical Support Manager for Datwyler about 12 years ago, supporting customers in a vast area, from Western European countries to distant countries like India, Korea, and South Africa. Thereafter, he headed the Global Prod-uct Introduction & Support team, a global team of highly experienced and educated people, having each their own expertise in the world of pharmaceutical closures. Bram himself acquired profound Extractables & Leachables expertise. His team managed customer projects of techni-cal nature and supported Datwyler’s product and portfolio management.Since end of 2012, he has been acting as Head of R&D for Datwyler’s Healthcare segment, leading a group that focuses on developing new rubber and new coating materials.

Bram JongenHead of Material Development, Container Closures & Injection SystemsDATWYLER Sealing Solutions

Speakers Biographies1 2

Andrea Simonetti received the MS degree and the PhD degree in elec-tronic engineering from the University of Ferrara, Italy. In his career he has successfully led large scale commissioning, validation and quality projects for worldwide major pharmaceutical regulated companies. Stan-dards, risk management, EU and FDA regulatory compliance are sig-nificant interests and responsibilities. He has designed and implemented pharmaceutical business plans and strategic development activities by leading and overseeing the activities of international sales teams. He has been also responsible for the strategic direction of business units at global pharma machine manufacturers. Andrea is a frequent speaker at conferences and seminars including ISPE, PDA, BFS IOA. In 2010 he started providing stable educational support to US Food and Drug Admin-istration Office of Pharmaceutical Science. He is a frequent contributor to leading pharmaceutical and engineering associations and his insights have been drawn on for topics ranging from conferences to scientific publications and regulatory dossiers. Most recent publications involve developing Process Analytical Technology strategies for pharmaceutical sytems and innovative Container Closure Integrity Testing methods for parenteral drugs. Andrea is currently working with PDA “Technical Report 27 – Pharmaceutical Package Integrity” and with PDA Prefilled Syringes task force teams.

Mike has been in Human Factors for over 20 years. He initially worked for Johnson and Johnson in the area of diabetes and blood glucose me-ters. After this he was Human Factors Manager for Teva Pharmaceuticals before joining Boehringer Ingelheim as Human Factors Engineer. During this time he has been responsible for introducing processes and proce-dures and interpreting HF regulatory guidance and standards for com-bination products. This has included packaging and labeling for which there is an increased focus in terms of safety and efficacy.

Andrea SimonettiHead of Sales and MarketingConvel Srl, Italy

Vonlanthen Group of Companies has extensive contacts with key decision makers at the world’s biggest companies. Our events and conferences bring industry lead-ers, deal makers, financiers and investors under one roof, providing you with unique sponsorship and branding opportunities that can deliver an immediate impact and put your message in front of a targeted, specialist audience. To get your company, product or service in front of a dedicated and engaged group of business leaders, contact us to discuss:• Conference exhibition opportunities to target new customers, enhance your reputation and strengthen relationships with existing clients• Event and conference sponsorship with branded materials and speaking opportunities• Webinars, podcasts, virtual conferences and short videos to generate leads, produce branded content and share your expertise• Using customer insights and feedback from social media to enhance product and service offeringsAll our sponsorship opportunities are bespoke and developed to enhance value for both our partners and Vonlanthen’s network of business leaders.

Sponsorship

Tino OtteSenior Scientific Consultant Intertek

Tino Otte joined Intertek (Switzerland) AG in 2016 as Senior Scientific Consultant specialized in extractables-leachables analysis and GMP test-ing. Before working at Intertek he studied analytical and polymer chem-istry in Leipzig and Halle (Germany). After earning his PhD at Darmstadt Technical University (Germany) he worked for different companies in the instrumental analysis and pharmaceutical services industry. Within the Intertek Group Tino Otte is responsible mainly for projects related to trace analysis, drug and impurity characterization or polymer testing.

Early Brid Discount:€300 - 1 person€500- 2 or more

Book until April 13th

Mike TateHuman Factors ManagerBoehringer Ingelheim, Germany