Berlin, Germany | October 19 - 20, 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

Dr. Tino OtteSenior Scientific Consultant Intertek, Switzerland

Mike TateHuman Factors ManagerBoehringer Ingelheim, Germany

Dr. Stefan SchelerSenior ScientistSandoz GmbH

Dieter MößnerProject Engineer PharmaEdelmann GmbH, Germany

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

Andrea SimonettiDirector of Sales and MarketingConvel Srl, Italy

Markus HemmingerSenior Pre-filled Syringe Engineer Roche, Switzerland

Daniela JanekAssociate Director Primary Packaging & Process Development Parenterals Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Dr. Charlotte PelletManager in Pharmaceutical Engineering, R&D Pharmaceutical Sciences OperationsSanofi, France

Dr. Oliver Valet Managing Director rap.ID Particle Systems, Germany

Key Speakers:

Key Practical Learning Points of the Summit:

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

Exhibit Sponsor:

Dr. Bart SteenackersStudy DirectorToxikon Europe, Belgium

#PFPS17

Chairman:

Berlin, GermanyOctober 19 - 20, 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 October 19-20, 2017, Berlin.

This premier event provides 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, and primary 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 October!

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

DESIGN AND PRIMARY PACKAGING

1 2

11:40 CASE STUDY

Requirements and concepts for secondary packaging for syringes, vials, and ampoules

DIETER MÖSSNERProject Engineer PharmaEdelmann GmbH

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 OneOctober 19, 2017

BUSINESS LUNCH13:00

MORNING COFFEE AND NETWORKING BREAK11:10

12:20 CASE STUDY

MATERIAL CHARACTERISATION

DR. STEFAN SCHELERSenior ScientistSandoz GmbH

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 the 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 the development process Standard folding boxes for ampoules, vials, and syringes Excursion: Packaging requirements for dental drugs – prefilled syringes Automated tamper evident boxes for ampoules Packaging development – one component instead of two Conclusions/recommendations for the practice

Selection of primary packaging materials for biopharmaceuticals: Special aspects for biosimilars A closer view of proteins in direct contact with materials in primary packaging Siliconized surfaces: Blessing and curse for biopharmaceuticals in prefilled syringes Squaring the circle: Strategies for bridging the needs for stability and injectability

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

DR. BART STEENACKERSStudy DirectorToxikon Europe

Introduction to extractables and leachables Regulatory aspects Designing extractable studies Designing leachable studies PQRI-PODP threshold approach

15:50

16:30

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

14:40 CASE STUDY

Risk management: The industry perspective

17:10 PANEL DISCUSSION

BUSINESS DINNER18:30

AFTERNOON COFFEE AND NETWORKING BREAK15:20

14:00

Silicone distribution and driving factors for subvisible particles arising from syringe siliconisation

DANIELA JANEKAssociate Director Primary Packaging & Process Development Parenterals Boehringer Ingelheim Pharma GmbH & Co. KG

1 2

With Speakers of the DayModerated by the Chairman

Day OneOctober 19, 2017

Strategies to reduce testing Real examples Lessons learned

CASE STUDY

Glass delamination studies for pharmaceutical vials – a general strategy

DR. TINO OTTESenior Scientific Consultant Intertek

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

MATERIALS CHARACTERISATION

Silicone oil distribution Break-loose and gliding forces Subvisible particles Evaluation of primary packaging materials Functionality

CASE STUDY

Rubber stopper formulation developments throughout the yearsBRAM JONGENHead of Material Development, Container Closures & Injection SystemsDATWYLER Sealing Solutions

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

CASE STUDY

Impact of silicone oil distribution and stability on particle concentration and gliding forces OLIVER VALET Managing Director rap.ID Particle Systems

Influence of storage conditions on silicone oil distribution Tell the good from bad containers before filling Measuring silicone layer thickness on cannulas In situ silicone oil stability and particle concentration correlation studies: Changes in the silicone oil distribution in filled syringes and cartridges over time Correlating silicone droplet and protein particle concentration by means of flow imaging and Raman identification

Registration and Welcome CoffeeOpening Address from the Chairman of Day2

09:0009:40

09:50 CASE STUDY

Concepts for manual and automated visual inspection

10:30 CASE STUDY

Temperature effects impacting time-pressure filling performance: From theory to experimental evidence

PROCESS INNOVATIONS

MORNING COFFEE AND NETWORKING BREAK11:10

TO BE ANNOUNCED

DR. CHARLOTTE PELLETManager in Pharmaceutical Engineering, R&D Pharmaceutical Sciences OperationsSanofi

BUSINESS LUNCH13:00

12:20 CASE STUDY

Container closure integrity for frozen drug products

ROMAN MATHAESPrincipal Scientist Senior Group Leader Lonza

1 2

11:40

Day TwoOctober 20, 2017

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

Time-pressure technology: Product viscosity plays a key role into performances Temperature effect is crucial for highly concentrated mAbs filling Difference in temperature between tank and laminar air flow hood/isolator can cause variation in mass filled immediately after stoppages This variation in mass filled is dependent on temperature difference and viscosity-temperature dependence Rational, simple, and quantitative theory explaining observations Practical solutions under investigation

CASE STUDY

New developments in non-destructive container closure integrity for parenteral products

ANDREA SIMONETTIHead of Sales and MarketingConvel Srl

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

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

15:20

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.

AFTERNOON COFFEE AND NETWORKING BREAK15:50

1 2

With Speakers of the DayModerated by the Chairman

Day TwoOctober 20, 2017

14:40

Pharmacoepial and GMP guidance Main compliance issues Latest regulatory trends

CCI testing of syringe barrels at dimensional extremes (facing requirements of updated USP <1207>)

MARKUS HEMMINGERSenior Pre-filled Syringe EngineerRoche

Background Description of test approach Calculation and sourcing of worst case samples Applied test method Test results

Advanced aseptic packaging in one operations cycle

WORKSHOP SESSION

Open opportunity for sponsors

Roman Mathaes is a group leader within the Lonza Drug Product Service organisation. 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 Ph.D. in pharmaceutical technology from the University of Munich for his work on subvisible particle characterisation.

For 20 years, Dieter Mößner has been working at Edelmann as a techni-cal project manager. He leads projects in Braille application, serialisa-tion, tamper verification and anti-counterfeiting of pharma and consumer good packaging, and consults customers and artwork agencies in artwork creation, print data communication and typesetting workflows. He is con-venor 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 medicinal 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.

Roman MathaesPrincipal Scientist Senior Group Leader Lonza, Switzerland

Dieter MößnerProject Engineer PharmaEdelmann GmbH Heidenheim,Germany

After his master’s 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 manag-er 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 product introduc-tion & support team, a global team of highly experienced and educated people, having each their own expertise in the world of pharmaceuti-cal closures. Bram himself acquired profound extractables & leachables expertise. His team managed customer projects of technical 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 seg-ment, leading a group that focuses on developing new rubber and new coating materials.

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

Bart Steenackers, born in Turnhout (Belgium) in 1987, is currently active as study director at Toxikon Europe NV. He obtained his master’s in bio-science engineering at the University of Leuven (2010, KU Leuven) and later his Ph.D. at the Centre for Surface Chemistry and Catalysis (2015, KU Leuven). As a doctoral and postdoctoral researcher, he studied the oxidation and isomerization of typical components of hops, acquiring ex-pertise in organic and analytical chemistry, solvent effects and catalysis. Mr. Steenackers joined Toxikon Europe NV in 2015 as a study director in the extractables and leachables department where his specialty fields include rubber closures and small volume parenteral applications.

Dr. habil. Stefan Scheler is senior scientist at Sandoz GmbH. He received his doctoral degree in pharmaceutical technology from the Friedrich-Al-exander University Erlangen-Nürnberg and performed post-doctoral re-search at the Friedrich-Schiller University Jena, where he completed his habilitation and was granted the authorisation to teach (venia legendi). He has about twelve years of experience in pharmaceutical development and worked for different companies. Beside this, he has five years’ expe-rience in hospital pharmacy. Scheler was involved in the development of a variety of different dosage forms for both small molecules and biophar-maceuticals. For a long time he is an expert in primary packaging materi-als. He has published numerous papers and is co-author of a standard textbook for pharmaceutical technology for which he has written, among others, a comprehensive chapter on packaging materials for pharma-ceuticals.

Dr. Stefan SchelerSenior scientistSandoz GmbH

Dr. Tino OtteSenior Scientific Consultant Intertek, Switzerland

Tino Otte joined Intertek (Switzerland) AG in 2016 as senior scientific consultant specialising 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 Ph.D. at Darm-stadt 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 characterisation or polymer testing.

Speakers Biographies1 2

Dr. Bart SteenackersStudy DirectorToxikon Europe, Belgium

Speakers Biographies1 2

Andrea Simonetti received a M.S. degree and the Ph.D. degree in elec-tronic engineering from the University of Ferrara, Italy. In his career he has successfully led large scale commissioning, validation, and qual-ity projects for worldwide major pharmaceutical regulated companies. Standards, risk management, EU and FDA regulatory compliance are significant interests and responsibilities of his. 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 busi-ness 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 Administration 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 pharma-ceutical systems and innovative container closure integrity testing meth-ods for parenteral drugs. Andrea is currently working with PDA ‘Technical Report 27 – Pharmaceutical Package Integrity’ and with PDA Prefilled Syringes task force teams.

Andrea SimonettiHead of Sales and MarketingConvel Srl, Italy

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 meters. After this, he was human factors manager for Teva Pharmaceuticals be-fore joining Boehringer Ingelheim as human factors engineer. During this time he has been responsible for introducing processes and procedures and interpreting HF regulatory guidance and standards for combination products. This has included packaging and labeling for which there is an increased focus in terms of safety and efficacy.

Daniela Janek studied biochemistry and biology at the University of Tübingen. After that, she recieved a doctoral degree from the Depart-ment of Medical Microbiology in Tübingen followed by a period as a post doc at the Interfaculty Institute of Microbiology and Infection Medicine Tübingen. Since February 2016, she is working as a labhead in primary packaging and process development for parenterals at Boehringer Ingel-heim in Biberach.

Markus Hemminger is a senior engineer who joined Roche in the year 2013, where he is assigned to the pre-filled syringe development, a sub-group of device development, for biopharmaceuticals. Currently, he is in charge of developing a syringe for ocular injections. Before starting at Roche, he was responsible for primary packaging development for biopharmaceuticals at Boehringer Ingelheim for more than 13 years. His main expertise includes selection, development and optimisation of con-tainer closure systems like vials, cartridges and syringes, as well as trans-fer and administration devices, packaging component related method and process developments and CCI testing. Markus Hemminger studied chemistry at the University of Applied Sciences in Aalen, Germany.

Dr. Charlotte Pellet graduated from ESPCI Paris in 2012. She special-ised in physics of fluids (master’s degree obtained from ENS Paris and UPMC) and completed her Ph.D. at the age of 27 years from Pierre and Marie Curie University. She is currently working in Sanofi as a manager in charge of process development in pharmaceutical sciences operations. Her mission is to bring support and expertise in fill & finish operations on parenteral products, medical devices (pre-filled syringes, autoinjectors) and especially on the rheology of protein solutions.

Dr. Oliver K. Valet is one of the co-founders of rap.ID Particle Systems GmbH; a company that develops, manufactures, and sells unique par-ticle identification systems. Within the last 15 years, their patented technology fuses particle isolation, imaging analysis and spectroscopic technology together to powerful investigation tools; streamlining particle contamination identification and particle characterisation. Within rap.ID Dr. Valet is responsible for the product development and worldwide mar-keting and sales. From the FDA inspected industrial forensics laboratory work performed at both rap.ID sites in Berlin, Germany and Princeton, New Jersey, Dr. Valet has more than a decade experience in the field of industrial and environmental chemical analysis on particles. As an ac-tive member of the Respiratory Drug Delivery (RDD), the Royal Chemical Society, Parenteral Drug Association (PDA), and American Association of Pharmaceutical Science (AAPS), and the Apothekerverband (APV) he has published his work continuously and presented on various conferences.

Mike TateHuman Factors ManagerBoehringer Ingelheim, Germany

Dr. Oliver Valet Managing Director rap.ID Particle Systems, Germany

Daniela Janek,Associate Director Primary Packaging & Process Development Parenterals Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Dr. Charlotte Pellet,Manager in Pharmaceutical Engineering, R&D Pharmaceutical Sciences OperationsSanofi, France

Markus Hemminger,Senior Pre-filled Syringe EngineerRoche, Switzerland