Manufacturing: Critical issues and solutionsProcess optimisation, monitoring, and controlInnovations in formulation developmentModel-based process engineeringQbD and PAT approachesStrategies to scale-up from R&D scale to full production levelTechnological solutionsStandards and validationRegulatory considerations

Exhibit Sponsors

Berlin, GermanyApril 27 - 28

2017

Hotel Eurostars Berlin Friedrichstrasse 9910117 Berlin, Germany

Key Practical Learning Points of the Summit:

Berlin, GermanyApril 27 - 28

2017

Key Speakers:

Dr. Stefan SchneidLaboratory Head Development Parenterals Bayer Pharma, Germany

Richard DenkHead Containment Group Skan AG, Switzerland

Dr. Sophie Declomesnil R&D Manager LYOFAL-SYNERLAB Group France

Dr. Andrea AllmendingerSenior Scientist, Group LeaderLate Stage Pharmaceutical & Processing Development, BiologicsHoffmann-La Roche, Switzerland

Dr. rer. nat. Patrick GaridelAssociate Director Protein ScienceBoehringer Ingelheim Pharma GmbH & Co. KG

Dr. Andrea SimonettiHead of Sales & MarketingConvel Srl, Italy

Franz Bosshammer, MBASenior SpecialistCD Execution/ExpertsNNE Pharmaplan, Germany

Dr. Jean René AuthelinGlobal Head of Pharmaceutical EngineeringSanofi-Aventis, France

Dr. Christoph KorpusLaboratory Head – Liquid Formulation StabilityMerck KGaA, Germany

Claudia KunzPh.D StudentUniversity of Erlangen-Nürnberg

Dr. Bram JongenHead of Material DevelopmentContainer Closures & Injection SystemsDATWYLER Sealing Solutions

Simon HowesSenior Product Development ScientistCatalent Pharma Solutions (Zydis)

Dr. Sune Klint Andersen, MBAPrincipal ScientistJanssen PharmaceuticalsDenmark

Dr. Andrea Weiland-WaibelManaging DirectorExplicat Pharma GmbH

Chairman of the Day 1 Chairman of the Day 2

This premier event provides the appropriate platform to discuss and network with peers involved in pharmaceutical manufacturing, R&D, quality control, engineering, and con-tainer development.The Summit will shed light on practical considerations for freeze-dried formulation development, process optimization, and validation and control for lyophilised biologics and vac-cines.It is an honour and privilege to invite you to participate in this Summit. We look forward to welcoming you at the Sum-mit in Berlin this coming April!

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Scientists, Chemists, Engineers and Fellows specialising in:

e are pleased to invite you to the Pharmaceutical Lyophilisation Summit scheduled for 27th and 28th of April 2017, in Berlin, Germany.W

Who Should Attend:

Berlin, GermanyApril 27 - 28

2017

BioprocessCharacterisationContainer developmentCMCDrug DevelopmentEngineeringFreeze-dryingFormulationLicensingLyophilisationNanomaterialsParenteralsPackaging & LabelingProcess TechnologyProcess Analytics

Company Type: Geographical Distribution:

PharmaceuticalBiotechnologyMedical DevicesCMOCRONOPOther

Europe United StatesCanada APAC Other

Vonlanthen Group of Companies is made for innovative and senior business leaders focused on confronting challenges and seizing opportunities. We conduct extensive research and con-nect deal-makers and risk-takers across Europe and emerging markets to help propel companies to the next level. Our confer-ences, events and training schemes are designed for senior de-cision-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.

About Us

Process Monitoring & Control Product InnovationPackagingQA/QCR&DRisk ManagementRegulatory AffairsStabilityStandardisationSterilizationValidationVaccinesCell Manufacturing

Registration and Welcome CoffeeOpening Address from the Chairman of Day 1

SPEED NETWORKING

08:2008:50

09:00

09:40

CASE STUDY

Lyoprocess development through analysis of critical quality attributes and the related critical process parameters

11:30 CASE STUDY

Automatic loading and unloading of pharmaceutical freeze dryer

MORNING COFFEE AND NETWORKING BREAK11:00

THE REGULATORY PERSPECTIVE

An 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.

1 2

- Analysis of critical quality attributes - Related critical process parameters- Lyorobustness testing to establish process boundaries- Modern lyoprocess validation and the implementation into regulatory lyophilisation

12:10 CASE STUDY - Optimal water content for drugs- Monitoring of residual moisture- Targeting of moisture contentsSecondary drying

FRANZ BOSSHAMMER, MBASenior Specialist, CD Execution/ExpertsNNE Pharmaplan, Germany

- Standardsystems!?- Which system design is suitable for which application: Pros and cons- Reasonable limits of automation- Instable containers and the impact on up-and-downstream- Possibility of upgrading

Day One | April 27, 2017

DR. ANDREA WEILAND-WAIBELManaging DirectorExplicat Pharma GmbH

DR. STEFAN SCHNEIDLaboratory HeadDevelopment Parenterals Bayer Pharma, Germany

MANUFACTURING LYOPHILISATION PRACTICES

10:20 CASE STUDY

Optimisation of industrial freeze drying cycle - 2 real life examplesDR. JEAN RENÉ AUTHELINGlobal Head of Pharmaceutical EngineeringSanofi-Aventis, France

- Two examples of ‘old’ products- How product physical characteristics (Tg’, eutectic melting, crystallization kinetics), process mathematical modelling and the equipment intrinsic limitations are taken into account- How this assists in designing a safe and economically efficient freeze-drying cycle

12:50 CASE STUDY - Process challenges during freeze-drying in DCCs- Selection of adequate holder devices- Process design and control with the ‘DCC-LyoMate’ procedureLyophilisation in dual chamber cartridges

(DCCs) – from energy transfer to process control

DR. CHRISTOPH KORPUSLaboratory Head – Liquid Formulation StabilityMerck KGaA, Germany

1 2

Controlled nucleation by vacuum-induced surface freezing

DR. ANDREA ALLMENDINGERSenior Scientist, Group LeaderLate Stage Pharmaceutical & Processing Development, BiologicsHoffmann-La Roche, Switzerland

14:30 CASE STUDY

Day One | April 27, 2017

UPDATES IN LYOPHILISATION PROCESS CONTROL

AFTERNOON COFFEE AND NETWORKING BREAK15:40

Freeze-drying of highly potent compounds

16:10 CASE STUDY

RICHARD DENK Head Containment Group Skan AG, Switzerland

- Freeze dryers equipped with isolators- Evaluation of critical limits- Cleaning validation

CHAIRMAN’S CLOSING REMARKS AND END OF DAY 1

BUSINESS DINNER

17:20

18:30

- New methods to better control the product’s CQA- New technology development- Innovative use of lyo: devices, solvent-based systems, and highly potent products

Innovation in freeze-drying

16:50 PANEL DISCUSSION

With Speakers of the DayModerated by the Chairman of Day1

- Recent development in controlled nucleation techniques- Presentation of optimised method using vacuum-induced surface freezing as recently disclosed by Hof Sonderanlagen and Hoffmann-La Roche- Experimental data on solid state characterisation and process monitoring compared to traditional nucleation- Challenges- Experimental data in comparison to other controlled nucleation techniques

Freeze-drying of organic co-solvent systems

CLAUDIA KUNZPh.D StudentUniversity of Erlangen-Nürnberg

15:10 CASE STUDY - Opportunities and limits- Thermal characteristics evaluated by DSC and freeze-dry Microscopy (FDM)- Specific features of the lyophilisation process and dried product

BUSINESS LUNCH13:30

Registration and Welcome CoffeeOpening Address from the Chairman of Day 2

09:0009:40

09:50 CASE STUDY

Quality by Design approach

10:30 CASE STUDY

Zydis®: A science and risk based approach to Lyophilisation

QBD, PAT AND SCALE-UP

1 2

MORNING COFFEE AND NETWORKING BREAK11:10

DR. SOPHIE DECLOMESNIL R&D Manager LYOFAL-SYNERLAB Group, France

- The role of freeze-drying in the Zydis technology- QBD aspects and determination of Critical Process Parameters (CPPs)- Development and scale-up of a Zydis freeze-drying cycle

Day Two | April 28, 2017

- Case study with an experimental plan (Doptimal model)- Design space for the freeze-drying cycle and to select the most appropriate process parameters

SIMON HOWESSenior Product Development ScientistCatalent Pharma Solutions (Zydis)

11:40 SPONSORS WORKSHOP

CONTAINER CLOSURE INTEGRITY TESTING

BUSINESS LUNCH12:40

12:00 CASE STUDY

Innovative solutions for the headspace gas monitoring of glass packages with lyo products

DR. ANDREA SIMONETTIHead of Sales & MarketingConvel Srl, Italy

- New developments in non-destructive Headspace Oxygen Analysis systems- Results of latest case study, investigations, and challenges encountered- How to use certified standard samples- Ways to get the best performance and to validate the system- Lessons learned- Points to consider

FREEZE-DRYING FORMULATION DEVELOPMENT

- Comparison of aseptic drying processes- Amorphous solid dispersions- Application to oral and parenteral formulations

CASE STUDY

The spray drying process in formulation development

13:40

DR. SUNE KLINT ANDERSEN, MBAPrincipal ScientistJanssen Pharmaceuticals, Denmark

TOMASO NIGRISManaging DirectorNicomac Europe SLR

1 2

Day Two | April 28, 2017

- Fogging- Container Closure Integrity Testing (CCIT)- Latest regulatory changes

Hot topics in Lyophilisation

16:10

CHAIRMAN’S CLOSING REMARKS AND END OF SUMMIT16:40

AFTERNOON COFFEE AND NETWORKING BREAK15:00

PANEL DISCUSSION

- Key elements in stopper design- Reduction of stopper stickiness to lyophilisation shelves- Low moisture rubber formulations and effect on the freeze-dried cake- Impact of the rubber stopper on the lyophilisation cycle

CASE STUDY

Rubber stoppers optimised for Lyophilisation purposes

15:30

DR. BRAM JONGENHead of Material DevelopmentContainer Closures & Injection SystemsDATWYLER Sealing Solutions

With Speakers of the DayModerated by the Chairman of Day2

What We Do

Vonlanthen 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.

- What is different?- Process and formulation development of HCFD drug products- Collapse and impact on product quality- Reconstitution of HCFD drug products- Case studies

CASE STUDY

The science of freeze-drying of highly concentrated protein formulations

14:20

DR. RER. NAT. PATRICK GARIDELAssociate Director / Protein ScienceBoehringer Ingelheim Pharma GmbH & Co. KG

INNOVATIONS AND TECHNOLOGIES

Speakers Biographies | 2 3

Jean René Authelin has an engineer degree in chemical engineering from ENSIC (Nancy France), and a PhD from The Institut National Polytechnique de Lorraine (France). He joined Rhone Poulenc in 1988 as a Chemical Engi-neer. In the 90’s he founded the Physical Quality function, dedicated to the API crystallisation, drying, polymorphism… for which he was for 10 years Global Head in Rhone Poulenc Rorer, Aventis and finally sanofi. In, 1988 JR Authelin was nominated Global Head of Pharmaceutical Engineering. Domains of interest of JRA include: thermodynamics of hydrates, drug polymorphism, amorphous solids physics, drug stability, crystallisation, nanoparticles engi-neering and processing, drying, milling; spray drying, fluid bed granulation, roller compaction, and freeze-drying. Jean René Authelin is the author or co-author of 20 publications or book chapters and the co-inventor of 9 patents.

DR. JEAN RENÉ AUTHELINGlobal Head of Pharmaceutical EngineeringSanofi-Aventis, France

DR. STEFAN SCHNEIDLaboratory Head Development Parenterals Bayer Pharma, Germany

Stefan Schneid is currently a laboratory head in the formulation development department at Bayer in Wuppertal. In this function, he develops formulations and processes for novel biological entities, including antibodies and ADCs, and is involved in development projects from pre-clinical stage up to transfer to commercial production. Previously Dr. Schneid worked as R&D Manager at Syntacoll GmbH in Saal, Germany, where he was responsible for the develop-ment of novel formulations and analytical methods for collagen-based drugs and medical devices for parenteral applications. Until 2010, he was a post-doctoral research fellow in the freeze-drying Focus Group at the University of Erlangen, and also spent one year as a visiting scientist in Prof. Michael Pikal’s lab at the University of Connecticut. Stefan Schneid holds a degree of pharmacy from the University of Munich, and received his Ph.D. in pharma-ceutics from the University of Erlangen in 2009 for his dissertation thesis titled “Investigation of Novel Process Analytical Technology (PAT) Tools for Use in Freeze-Drying Processes”. He developed and optimised the formulation and manufacturing process of various pharmaceutical drugs including proteins, peptides, vaccines and small molecules.

DR. SUNE KLINT ANDERSEN, MBAPrincipal ScientistJanssen Pharmaceuticals, Denmark

Dr. Sune Klint Andersen is Principal Scientist in Drying Processes and Particle Technology in CMC at Novo Nordisk A/S, Denmark. He has Ph.D. in chemical engineering – nanoparticle technology and MBA in management & technolo-gy. Main interests and professional experience include development of drying processes for drug substances, intermediates, excipients and drug products for both R&D and industrial scale purposes as well as application of Quality-by-Design in drying processes, validation and qualification of spray dryers, and advantages & disadvantages of spray vs freeze-drying processes. Given several presentations on international courses and published articles on the above subjects. Extensive experience in design and development of spray drying equipment and processes, bulk freeze-drying processes, GMP produc-tion, nanoparticles, powder processing in general, DoE and application of Quality-by-Design, validation and qualification of spray dryers, scale-up of spray drying processes, particle engineering, and aseptic spray drying. Been with Novo Nordisk for 8 years and before 8 years with Niro A/S (working with pharmaceutical spray drying of proteins, inhalable particles, computational fluid dynamics of spray dryers, droplet kinetics, aseptic spray drying etc.)

Dr. Patrick Garidel is currently employed as associate director protein science at Boehringer Ingelheim Pharma GmbH & Co. KG. His activities are focused on the development biologics from the downstream process to drug product (liquid and solid formulations, freeze-drying). His expertise covers: develop-ment of drug delivery system and formulations, packaging/devices, process development, bio-analytic, and protein purification. He is responsible for the establishment of innovative platform technologies for e.g. powder inhalation, gene therapy, in silico based predictive tools for molecule properties, and particle analytics. Additionally, he is interested in the development of new con-cepts and strategies for protein purification, stabilisation, delivery and protein/colloid chemistry in general. PG studied chemistry and biotechnology at the University of Kaiserslautern and pharmaceutical sciences at the University of Strasbourg. He has a PhD in biophysics. During his academic career, he took over various post doc positions at the Institute for Pharmaceutical Technology and Biopharmacy, physical chemistry at the Martin Luther University Halle/Wittenberg, DESY, Rutgers University and Hospital for Special Surgery.

DR. RER. NAT. PATRICK GARIDELAssociate Director Protein ScienceBoehringer Ingelheim Pharma GmbH & Co. KG

DR. ANDREA ALLMENDINGERSenior Scientist, Group LeaderLate stage pharmaceutical & processing development, BiologicsHoffmann-La Roche, Switzerland

Andrea Allmendinger joined Hoffmann-La Roche Basel in 2013, where she currently holds the position of a senior scientist and group leader in the de-partment of ‘Late-stage Pharmaceutical and Processing Development’ for par-enteral products. Her projects include the formulation and process develop-ment of parenteral drug products for clinical PhIII and market. She started with commercial product support focusing on technical transfers of NCEs and NBEs in particular on process characterisation and validation for freeze-dried products. Andrea’s research lately focuses on all aspects of formulation de-velopment of freeze-dried formulations supervising several Master and PhD students. Most recently, she became assistant lecturer at the University of Freiburg in the department of pharmaceutical technology and biopharmacy. Andrea is a pharmacist by training and conducted her studies at the University of Heidelberg in Germany and at the University College London. She holds a PhD in Pharmaceutical technology from the University of Basel where she focused on rheological behaviour of liquid high-concentration protein formula-tions.

1

SIMON HOWESSenior Product Development ScientistCatalent Pharma Solutions (Zydis)

Simon Howes is a senior product development scientist at Catalent Pharma Solutions in Swindon, UK. Simon has worked for Catalent for over 20 years within the R&D function in Swindon, focusing on the development of formu-lations for the proprietary Zydis® technology. Zydis is a freeze-dried orally disintegrating tablet (ODT) which, when placed in the mouth, dissolves in 1-2 seconds in contact with the saliva. As part of his role Simon has been responsible for developing suitable freeze-drying cycles at both bench and pilot scale, under the guidance of Quality by Design (QBD). Through this work Simon has gained significant knowledge in the understanding of freeze-drying and the critical process parameters which can affect the finished product. Si-mon holds a HNC in Chemistry from the University of the West of England and a BSc (Hons.) in pharmaceutical science from the University of Greenwich.

DR. SOPHIE DECLOMESNIL R&D Manager LYOFAL-SYNERLAB Group, France

Sophie Declomesnil is the manager of research and development at LYOFAL (SYNERLAB group) leading collaborative research activity of client projects. Over the past 20 years, she has been working at Lyofal and is responsible for the lyophilisation development of the company focusing on formulation, freeze-drying cycle development and thermal properties of the products and also tech transfer. After graduating in science and engineering in the graduate Agrosup DIJON, a French National Institute of technology for Life, Food and Environmental Sciences, she received a doctorate in biotechnology from the University of Picardie (France).

Andrea Simonetti received a MS degree and a PhD degree in electronic engi-neering 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. Standards, risk management, EU and FDA regulatory compliance are significant interests and responsibili-ties. 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 direc-tion 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 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 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.

DR. ANDREA SIMONETTIHead of Sales & MarketingConvel Srl, Italy

DR. BRAM JONGENHead of Material DevelopmentContainer Closures & Injection SystemsDATWYLER Sealing Solutions

After his Masters in polymer chemistry at the University of Louvain, Belgium, Bram Jongen acquired a Ph.D. in water soluble polymers used for advanced drug administration. Bram started as technical support manager for Datwy-ler 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 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 technical nature and supported Datwyler’s product and portfolio management. Since end of 2012, he has been acting as head of R&D for Dat-wyler’s healthcare segment, leading a group that focuses on developing new rubber and new coating materials.

Richard Denk has studied mechanical engineering and did examination on Experts of GMP, qualification and validation, pharmaceutical auditing, Phar-maceutical Engineering, Quality Control on the University of Applied Sciences in Albstadt/Sigmaringen Germany. Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position head sales containment. Mr. Denk founded 8 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the Containment Manual in Sep-tember 2015. Mr. Denk has spent nearly 20 years with the subject production of highly active/highly hazardous substances and has developed the contain-ment pyramid.

RICHARD DENKHead Containment GroupSkan AG, Switzerland

DR. CHRISTOPH KORPUSLaboratory Head – Liquid Formulation StabilityMerck KGaA, Germany

FRANZ BOSSHAMMER, MBASenior SpecialistCD Execution/ExpertsNNE Pharmaplan, Germany

Franz Bosshammer has a degree in mechanical engineering, as well as a Master of Business Administration (MBA). Prior to joining NNE Pharmaplan in October 2012, Franz has filled various positions, such as process engineer and sales director in the supplying industry for pharmaceutical, aseptic fill and finish machines. His latest employment was as general manager at the Optima Group pharma. He started his career in the field of process engineer-ing in 1986. Franz has more than 30 years of experience in development and manufacturing of machines for aseptic pharmaceutical operations, with a special focus on freeze-drying technology. Franz has been engaged in various international fill and finish projects during the last decades.

Christoph Korpus graduated in pharmacy at the Goethe-University in Frank-furt am Main, Germany. He finished his PhD thesis at the Ludwig-Maximil-ians-Universität Munich under the supervision of Prof. Wolfgang Frieß. His research focused on the lyophilisation process development for Dual Chamber Cartridges. This included energy transfer studies and the analysis of different holder devices. For his 3 month research stay at the University of Connecticut, in the group of Prof. Michael Pikal, he was awarded with a graduate student scholarship from the German Academic Exchange Service. Since 2016, he is leading the liquid formulation stability laboratory at Merck KGaA (Germany) in Darmstadt. His current research focuses on the development of high grade excipients for final formulations.

Speakers Biographies | 2 31

Claudia Kunz received her degree in studies in pharmacy from the University of Wuerzburg. Since 2013, Claudia is a PhD student in the division of pharma-ceutics at the Friedrich-Alexander-University in Erlangen and member of PD Dr. Gieseler’s Freeze-Drying Focus Group. Her research interest is focused on freeze-drying of organic co-solvent systems. This involves thermal analysis of the pre-dried solutions as well as characterisation of the final lyophilisates to establish a link to process and product performance.

CLAUDIA KUNZPh.D StudentUniversity of Erlangen-Nürnberg

Speakers Biographies | 2 31

Andrea Weiland, Ph.D., is managing director of Explicat® Pharma GmbH, a privately owned company providing technical project management services and pharmaceutical development services to Pharmaceutical Industry (CMC).Andrea is a pharmacist with a Ph.D. in pharmaceutical technology on biode-gradable microspheres and cyclodextrins (Ludwig Maximilians University Mu-nich). She held several leadership positions within Pfizer, working as project manager in process technology and being responsible for technology trans-fer & process development, mainly on sustained release solid dosage forms. Within R&D she was responsible scientist for pharmaceutical development (Phase I - III, candidate characterization and lyophilisation projects). After joining IDEA AG, a biotechnology company based in Munich, Andrea Weiland held the position of director pharmaceutical development and was responsible for process technology development, drug delivery system development (li-posomes, patches), formulation of recombinant proteins, analytical develop-ment, and clinical supplies manufacture; she also served as IDEA`s QP. She is founder of Explicat Pharma GmbH and managing director since 2005. Hers and her team`s experience cover the development of biopharmaceuticals (e. g. recombinant factor VIII), development of lyoformulations and lyocycles,analytical development and related QA as well as regulatory issues. Expli-cat Pharma has been assigned several projects involving the modern process validation approach, including lyocycle robustness testings. Andrea Weiland is qualified person and a member of AAPS as well as several other professional institutions based in Europe, e.g. APV, DphG, Bay. LAK, A3P.

DR. ANDREA WEILAND-WAIBELManaging DirectorExplicat Pharma GmbH

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Upcoming co-located Events

Packaging for Parenterals Summit 8th - 9th June 2017 | Berlin, Germany

Packaging for Parenterals Summit scheduled for June 8th and 9th 2017, in Berlin, Germany provides the appropriate platform to discuss and network with peers involved in parenteral manu-facturing, packaging, quality control, container development and regulatory affairs. The summit will shed light on regulatory updates, CCI testing, va-riety of materials and their characteristics, drug stability, 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 coming June!

Annual Extractables and Leachables Summit 8th - 9th June 2017 | Berlin, Germany

We are pleased to invite you to the Annual Extractables and Leachables Summit scheduled for June 8th and 9th 2017, in Ber-lin, Germany.This summit brings together leading industry professionals in-volved in pharmaceutical manufacturing, toxicology, quality con-trol, devices, single-use systems, equipment and container de-velopment. Summit is focused on guideline updates, analytical testing innovations, and the impact of E&L on biologics safety. It is an honour and privilege to invite you to participate in this Sum-mit. We look forward to welcoming you at the Summit in Berlin this coming June!

Pharmaceutical Lyophilisation Summit Venue Info

Hotel Eurostars BerlinFriedrichstraße 99

10117 Berlin, Germany+44(0)8435080328

www.eurostarshotels.co.uk