PHARMACEUTICAL LYOPHILIZATION SUMMIT 2021 - VIRTUAL CONFERENCE 29-30 July 2021 - GOLD PARTNER - Qepler
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
GOLD PARTNER ▸ 12+ Program Hours ▸ WORKSHOPS ▸ Networking ▸ Panel Discussions | Q & A ▸ Video Recording 3rd Annual PHARMACEUTICAL LYOPHILIZATION SUMMIT 2021 29-30 July 2021 ● VIRTUAL CONFERENCE 12:00 - 18:30 CEST (Prague - UTC/GMT +2 hours) AGENDA WEB LinkedIn
SPEAKERS BOARD Michael Dekner Roman V. Loretts PARTNER Innovation & External Collaborations Regional Manager Takeda, AT ELLAB A/S, DK Dr. Andrea Weiland-Waibel Jean-René Authelin Managing Director Global Head of Pharmaceutical Explicat Pharma GmbH, DE Engineering Sanofi-Aventis, FR Dr. Simon Kervyn Diego Zurbriggen Manager Materials Development Technical Account Manager Datwyler Pharma Packaging West Pharmaceutical Services, USA International NV, BE Dr. Mattia Cassanelli Ian Blackham Technical Manager – Consultancy Business Development Executive – Biopharma Group, UK Instruments Biopharma Group, UK Dr. Patrick Garidel Georg Frinke, Dipl.-Ing. (FH) Head of Process, Purification and Pharma Senior Manager Engineering Development, Biopharma Ferring GmbH, DE Boehringer Ingelheim, DE Paul Matejtschuk, PhD, CChem, FRSC Prof. Geoff Smith Section Head, Standardisation Science, Professor of Pharmaceutical Process Analytical and Biological Sciences Analytical Technology Division De Montfort University, UK NIBSC, UK Matthias Erber Dr. Sune Klint Andersen Scientist External Cooperations Principal Scientist DPD – Oral Solid Bayer, DE Dosage Janssen, BE www.qepler.com +420 608 030 490 register@qepler.com
TRACKSENSE LYOPRO ® What A revolutionary wireless data logger specifically designed for accurate is it? measurements in freeze dryers with vial autoloading systems. HOW IT WORKS 1 2 Start the data loggers Fit the data with the LyoPro Reader loggers with the Station and program required TRACKSENSE them using ValSuite accessories LYOPRO ® 3 4 Retrieve LIVE Place the data loggers Once the process is DATA in the process and complete, deactivate ensure proper the data loggers by through the placement on shelves placing them in the access point reader station COLLECT EVALUATE ValSuite works in a Client/Server SHARE Read data from multiple environment data loggers as they communicate with the software real-time. Accessed directly from your PC. Features & Benefits More than 100 transmitting Save time with Eliminates data gaps data loggers in one study LIVE data from start to finish The compact data logger includes a battery, storing all data and offering you the peace of mind you deserve. Effortless Stay compliant Ensure Industry leading installation and and secure sample integrity software placement Avoid calibration down-time Ensure FDA compliance by using an industry leading Ensure sample integrity by software that focuses on data using ultra-thin exchange- integrity and SCADA/CITRIX- able thermocouple sensors /ACS system compatibility for with high accuracy and central access and control. pin-point positioning. Perform on-site user calibrations via an embedded ValSuite DON’T SETTLE FOR LESS. software functionality . Revolutionize Your Freeze-Drying Process with TrackSense LyoPro. Global expertise with local reach
WHO YOU WILL MEET SNAPSHOT OF ATTENDEES - VIRTUAL 2nd Annual Extractables & Leachables Conference 2020: 3P Biopharmaceuticals, ES - Abbott Healthcare Products B.V., NL - Abbvie Deutschland GmbH & Co. KG, DE - Accord-UK Ltd, UK - Advent Consulting Canada, CA - ALK, DK - Alkermes Pharma Ireland Limited, IE - Alphamed Formulations PVT LTD, IN - Apotex Research Pvt Ltd., IN - Aspen Holdings, ZA - Aspen Pharmacare, ZA - B.Braun medical SA, CH - Bavarian Nordic, DK - Becton Dickinson, CN - Becton Dickinson, FR - Biogen, USA - Boston Analytical, USA - Claudia Cusa, d.i., IT - CSL Behring AG, CH - Datwyler Pharma Packaging International NV, BE - DuPont, USA - DuPont-Asahi Flash Spun Products, JP - EirGen Pharma, IE - Eli Lilly and Company, USA - EMS SA, CH - Eurofins Analytical Science Laboratories, Inc., JP - Fujifilm Diosynth Biotechnologies, UK - GSK, US - GSK Vaccines, BE - Hall Analytical, UK - Hemofarm AD, RS - HTL-Strefa S.A., PL - Intertek (Schweiz) AG, CH - Janssen, USA - Kora Healthcare, IE - LEO Pharma, IE - Maven E&L Ltd, UK - Medline Industries, USA - Merck KGaA, DE - MilliporeSigma a business of Merck KGaA, USA - Novartis, CH - Novartis Pharma Stein AG, CH - NOVAVAX CZ a.s., CZ - Orexo AB, SE - Orion Corporation - FI, Philips, NL - Polifarma İlaç San. ve Tic. A.Ş., TR - PPD, IE - Rentschler Biopharma SE, DE - Safetree Consulting e.U., AT - Sandoz Manufacturing Inc., CA - Sanofi, FR - Sanofi, DE - Sanofi Pasteur, CA - Sartorius Stedim Biotech GmbH, DE - SCHOTT AG, DE - SCIEX, UK - Selvita S.A., PL - Septodont, FR - SGS, CN-TW - SGS Institut Fresenius GmbH, DE - Solvias AG, CH - Sthree, BE - Swedish Biomimetics 3000 Ltd, UK - Takeda Pharmaceuticals, USA - Vet-Agro Sp. z o.o., PL - West Pharmaceutical Services, USA - Wockhardt Ltd, IN - and others. Agenda: https://qepler.com/agendas/agenda-2nd-extractables-and-leachables-20.pdf SNAPSHOT OF ATTENDEES - 2nd Annual Pharmaceutical Lyophilization Summit 2020: Allergan - Aptar Pharma - AZBIL TELSTAR TECHNOLOGIES SLU - Baxalta Manufacturing Sàrl - Bayer AG - BB-NCIPD Ltd. - Biopharma Process Systems Ltd - BLAC-BioPharma UG - Boehringer Ingelheim - Datwyler Pharma Packaging International NV - De Montfort University - DendroPharm GmbH - Elm o Sanat University - Freie Universität Berlin - Ghent University - INDICAL BIOSCIENCE GmbH - Janssen - KSHM-Rezonanca - Lek Pharmaceuticals d.d. - Lonza AG - Martin Christ Gefriertrocknungsanlagen GmbH - Masaryk University - MSD - MSD International - Novartis Global Drug Development / Technical Research & Development - Pensatech Pharma - Pfeiffer Vacuum GmbH - Pfizer - PharmaCept GmbH - Polpharma SA - Rhine Waal University - Sanofi - SCHOTT AG - Shire Austria GmbH now part of Takeda - Surface Measurement Systems Ltd. - Takeda - Tempris GmbH - VLB Berlin - West Pharmaceutical Services Deutschland GmbH & Co KG and others. Agenda: https://qepler.com/agendas/pharmaceutical-lyophilization-summit-2020.pdf POSITIONS ▸C-Level, Presidents, Chairs, Members of the Board & VPs ▸Vice presidents, Directors, & Heads ▸Leaders & Managers ▸Principals, Engineers, Analysts & Scientists ▸Instructors & Trainers & Teachers ▸Advisors, Coordinators, Auditors & Consultants ▸Other Professionals, Experts & Specialists DIVISIONS ▸Lyophilization ▸QA/QC ▸Container Development & Container ▸Pharmaceutical Manufacturing, ▸Characterisation Closures Engineering & New Technologies ▸Regulatory Affairs ▸Vials, Stoppers & Dual Chamber Systems ▸Laboratory Management ▸Stability ▸Devices &Application Systems ▸R&D ▸Standardisation ▸Product Development & Control ▸Formulation ▸Qualification & Validation ▸Parenteral Production ▸Containment ▸Scale-up & Technology Transfer ▸Injection Systems ▸Pharmaceutical & Processing ▸Cycle Management ▸Vaccines Development ▸Facility & Site Design & Management ▸Corporate & Business Development ▸ Process Design, Technology, Analytics, ▸PAT, QbD ▸External Supply Testing, Monitoring & Control ▸Media Fills ▸Sales & Marketing ▸Aseptic Production, Cleaning & ▸Visual Inspection ▸Outsourcing Sterilisation ▸Filling & Materials ▸Partnerships & Alliances ▸Bioprocessing ▸Materials Development ▸Strategic Development ▸Other INDUSTRIES INDUSTRIES ▸Pharmaceutical ▸NOPs ▸Biotechnology ▸Regulatory Agencies ▸Chemical ▸Bioprocessing services and ▸Medical Devices equipment ▸CDMOs ▸Equipment suppliers ▸CMOs ▸Training providers ▸CROs ▸Other www.qepler.com +420 608 030 490 register@qepler.com
PHARMACEUTICAL LYOPHILIZATION SUMMIT 2021 July 29 | 1st DAY Central European Summer Time (CEST, Prague, UTC/GMT +2 hours) 12:00 - 12:20 ✍ Registration 12:20 - 12:30 Opening Address from the Chairman 12:30 - 13:00 A 2020 hindsight look at how COVID-19 has affected the freeze drying industry and what we have learned from it. ▸Main challenges in 2020 seen from the eyes of a CDMO ▸Development and manufacturing of PCR assay in lyocakes and lyobeads ▸Development of lyo candidate vaccines ▸Development of lyo blood products Dr. Mattia Cassanelli | Technical Manager – Consultancy Biopharma Group, UK 13:00 - 13:10 ⁉ Q&A 13:10 - 13:40 Speed Networking 13:40 - 14:10 Taking into account Kv distribution in freeze drying simulation. Theory of freeze drying was set up in the 80’s by pioneering work of Pikal. Although very simple (1D, quasi steady state), the model provides very good representation of the reality, the only limitation is that it uses average value. However it is well known that the edge vials are much hotter than center vials, due to radiation impact. This difference in temperature may result in heterogeneities in the product : if the cycle is too aggressive, edge vials may collapse, or if it the primary drying is too short some residual ice may still be present when the cycle is moving to secondary drying, leading to melt back. We will present a new process simulation methodology, based on the distribution of Kv’s which allows top predict the variability of product temperature and primary drying time. Real life examples will be discussed. Jean-René Authelin | Global Head of Pharmaceutical Engineering Sanofi-Aventis, FR 14:10 - 14:20 ⁉ Q&A 14:20 - 14:30 ☕ Break 14:30 - 15:00 TrackSense® LyoPro GOLD PARTNER Ellab all-in-one Solution for Qualification, Validation, Monitoring and Batch Control. Roman V. Loretts | Regional Manager ELLAB A/S, DK 15:00 - 15:10 ⁉ Q&A 15:10 - 15:40 Aseptic Process Simulation for Lyophilization – Best Practice, an Industry Opinion ▸Aseptic process simulation (APS) for lyophilized products. ▸Annex 1 revision in relation to APS. ▸Proposed best practice. Michael Dekner | Innovation & External Collaborations Takeda, AT 15:40 - 15:50 ⁉ Q&A www.qepler.com +420 608 030 490 register@qepler.com
PHARMACEUTICAL LYOPHILIZATION SUMMIT 2021 July 29 | 1st DAY Central European Summer Time (CEST, Prague, UTC/GMT +2 hours) 15:50 - 16:20 Heat transfer at sublimation – a theoretical assessment of experimental results. ▸Variable heat transfer on the shelf, reasons of edge effect ▸Calculation of drying progress ▸Experimental validation based on different PAT-Tools ▸Assessment of current Qualification procedures ▸Risk mitigation for cycle transfer Georg Frinke, Dipl.-Ing. (FH) | Senior Manager Engineering Ferring GmbH, DE 16:20 - 16:30 ⁉ Q&A 16:30 - 16:40 ☕ Break 16:40 - 17:10 Introducing TVIS PAT technology. ▸Process analytical technologies (PAT) for freeze-drying ▸Dielectric properties of frozen solutions ▸Non-invasive spectroscopic PAT methods Prof. Geoff Smith | Professor of Pharmaceutical Process Analytical Technology De Montfort University, UK 17:10 - 17:40 Through Vial Impedance Spectroscopy and its application in the freeze drying of biologicals. ▸Simple excipients to complex formulations ▸Identification of “in vial” freezing and primary drying events ▸Monitoring of location and its impact on drying Paul Matejtschuk, PhD, CChem, FRSC | Section Head, Standardisation Science, Analytical and Biological Sciences Division National Institute for Biological Standards and Control (NIBSC), UK 17:40 - 17:50 ⁉ Q&A 17:50 - 18:20 Towards Realization of Continuous Drying Technologies for Biopharmaceuticals. ▸Challenges in drying of biopharmaceuticals ▸Aseptic Spray Drying ▸Continuous & Controlled Single Vial Lyophilization ▸Continuous manufacturing pros and cons for various technologies Dr. Sune Klint Andersen | Principal Scientist DPD – Oral Solid Dosage, Janssen, BE 18:20 - 18:30 ⁉ Q&A 18:30 - 18:40 Closing remarks and end of Day 1 www.qepler.com +420 608 030 490 register@qepler.com
PHARMACEUTICAL LYOPHILIZATION SUMMIT 2021 July 30 | 2nd DAY Central European Summer Time (CEST, Prague, UTC/GMT +2 hours) 12:00 - 12:10 Opening Address from the Chairman 12:10 - 12:40 Freeze-Drying of Highly Concentrated Biologics. ▸Challenges for processing highly concentrated protein formulations. ▸Freeze-drying of concentrated protein solutions. ▸Analytics & stability properties of HCFDF. ▸Impact on reconstitution. Dr. Patrick Garidel | Head of Process, Purification and Pharma Development, Biopharma Boehringer Ingelheim, DE 12:40 - 12:50 ⁉ Q&A 12:50 - 13:35 Lyocycle Development and Transfer/Process Performance Qualification of an amorphous cyclodextrin based lyoproduct into production scale and experiences during routine production. ▸Critical Quality Attributes of Lyo Products. ▸The Critical Formulation Temperature and the rational design of the lyocycle. ▸Lyocycle robustness and the Transfer/PPQ into routine production. ▸Ongoing Process Verification during lifecycle, experiences during routine production. Dr. Andrea Weiland-Waibel | Managing Director Explicat Pharma GmbH, DE 13:35 - 13:45 ⁉ Q&A 13:45 - 13:55 ☕ Break 13:55 - 14:35 WORKSHOP: Validation with Wireless Loggers GOLD PARTNER Practical Aspects and Experience from Ellab. ▸Pre- and Post- Calibration ▸Introduction and placement ▸Data analysis and report generation ▸Time savings Roman V. Loretts | Regional Manager ELLAB A/S, DK 14:35 - 14:45 ⁉ Q&A 14:45 - 15:45 WORKSHOP: Role and measurement of mechanical properties in lyobeads technology. The use of Lyobeads is becoming more popular within the Lyophilisation industry, due to their size and structure it is extremely important to understand the strength of the product and sustainability for their use. Utilising the MicroPress Mechanical Property Analyser, tests can be carried out on the Stress and Strain of the final product. ▸Lyobead technology. ▸Uses of Lyobeads. ▸How to determine the strength of your Lyobead. ▸What can influence weakness within the Lyobead. Ian Blackham | Business Development Executive – Instruments Dr. Mattia Cassanelli | Technical Manager – Consultancy Biopharma Group, UK 15:45 - 15:55 ⁉ Q&A 15:55 - 16:05 ☕ Break www.qepler.com +420 608 030 490 register@qepler.com
PHARMACEUTICAL LYOPHILIZATION SUMMIT 2021 July 30 | 2nd DAY Central European Summer Time (CEST, Prague, UTC/GMT +2 hours) 16:05 - 16:35 How to choose the optimal stopper for lyophilization application? ▸Selection of a rubber stopper design intended for lyophilisation purposes. ▸Reduction of stopper stickiness to lyophilisation shelves. ▸Effect of the rubber formulation on moisture content. ▸Moisture determination using Karl-Fisher versus Loss-on-Drying. ▸Low moisture rubber formulations and effect on the freeze-dried cake, combining different methods. Dr. Simon Kervyn | Manager Materials Development Datwyler Pharma Packaging International NV, BE 16:35 - 16:45 ⁉ Q&A 16:45 - 17:15 Primary Packaging Risk Mitigation: A Customized Physical and Chemical Evaluation. ▸Review primary packaging risks impacting lyophilized drug product quality. ▸Holistic understanding of the drug product manufacturability and fit for purpose. ▸Plan a chemical and physical performance testing design based on drug product requirements. ▸Assess testing results for drug product risk mitigation. Diego Zurbriggen | Technical Account Manager West Pharmaceutical Services, USA 17:15 - 17:25 ⁉ Q&A 17:25 - 17:35 ☕ Break 17:35 - 18:05 Freeze-drying of highly potent APIs using protective bags - Characterization of heat and mass transfer. ▸Case study on the usage of protective bags during Freeze-Drying ▸Concept of blow-out as a contamination/safety issue ▸Relevance and value of sublimation tests to understand your process ▸Influence of protective bags on your freeze-drying process Matthias Erber | Scientist External Cooperations Bayer, DE 18:05 - 18:45 Panel discussion 18:45 - 18:55 Closing remarks and end of summit www.qepler.com +420 608 030 490 register@qepler.com
PHARMACEUTICAL LYOPHILIZATION SUMMIT 2021 SPEAKER’S BIOGRAPHIES Ian Blackham Ian joined the Biopharma Group in July 2019 and currently works as the Business Development Executive for the Lyophilisation Instruments Business Development Executive – Division which includes Freeze Drying Microscopes, Lyotherm DTA & Impedance Analysers and MicroPress Mechanical Property Analysers. With over twenty-five years’ experience within the cryopreservation industry, Ian is now utilising his knowledge of critical temperatures within the Instruments Lyophilisation sector, helping to provide the scientific data to ensure the correct parameters are understood when Lyophilising various product Biopharma Group, UK formulations. Over the years Ian has been an advisor to many sectors on the safe storage conditions of biological products from small single cell samples to large tissue storage. Michael Dekner Michael Dekner has studied biotechnology at the University of Life Sciences Vienna. Since graduating 16 years ago he has held positions as scientist Innovation & External in enzyme engineering (Biomin), antibody design (f-Star), since joining Takeda as a supervisor for lyophilization and crimping, manager for process and technology innovation and has lead a team of scientists developing and optimizing fill and finish processes. Currently Michael holds the Collaborations position of associate director for innovation and external collaboration Takeda, AT Dr. Simon Kervyn Simon Kervyn graduated as a PhD in organic chemistry and materials from the University of Namur, Belgium in 2012. After research stays at National Manager Materials Development Institute of Materials Sciences in Tokyo and at UCLA, Los Angeles, he worked at the Coatings Research Institute in Belgium. He is now working for Datwyler as manager surface development. In this position he performs customer’s dedicated research to optimize the Datwyler Pharma Packaging selection of rubber components to their applications. Furthermore, he works on the development of coated products for the Datwyler portfolio. International NV, BE He is a frequent speaker at conferences. Georg Frinke Georg Frinke is employed as senior manager Engineering at Ferring Kiel and engaged as a honorarium professor at the DeMontfort University of Senior Manager Engineering Leicester. He has 20 years of experience in the field of pharmaceutical freeze drying. Ferring GmbH, DE Dr. Patrick Garidel Dr. Patrick Garidel is currently employed as associate director protein science at Boehringer Ingelheim Pharma GmbH & Co. KG. His activities are Head of Process, Purification and focused on the development biologics from the downstream process to drug product (liquid and solid formulations, freeze-drying). His expertise covers: development of drug delivery system and formulations, packaging/devices, process development, bio-analytic, and protein purification. He Pharma Development, Biopharma is responsible for the establishment of innovative platform technologies for e.g. powder inhalation, gene therapy, in silico based predictive tools for Boehringer Ingelheim, DE molecule properties, and particle analytics. Additionally, he is interested in the development of new concepts 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. Prof. Geoff Smith Geoff Smith is Professor of Pharmaceutical Process Analytical Technology in the Leicester School of Pharmacy at De Montfort University (UK). Professor of Pharmaceutical His research group focusses on pharmaceutical applications for impedance, dielectric and terahertz spectroscopies alongside optical techniques such Process Analytical Technology as laser speckle and optical flow. He is responsible for the development of through-vial impedance spectroscopy (TVIS) as a PAT tool for monitoring phase behaviour (ice formation De Montfort University, UK and eutectics), ice interface temperatures, primary drying rates and end points. This development marks the first time that impedance spectroscopy has been used to characterize materials within conventional glass freeze-drying vials, without having to insert the electrodes into the product (i.e. the solution under-going freeze-drying). This feature of the technology sets it apart from other in-process impedance measurement systems, in which a bulky electrode assembly is inserted into the solution being freeze-dried, to provide a product-non-invasive technology. Dr. Mattia Cassanelli Mattia joined Biopharma Group in February 2018 and he currently works as a Technical Manager of the Consultancy Division, providing support Technical Manager – Consultancy through desktop study, cycle audit, characterisation of the material pre- and post- process, formulation development, optimisation of the freeze drying cycle and tech transfer/scale-up. Biopharma Group, UK Mattia’s background includes a PhD focussed on drying mechanisms of hydrocolloids in the food industry from a microstructural point of view at the University of Birmingham. He also gained a Master’s Degree in material engineering, and a Bachelor’s Degree in industrial engineering completed at the University of Trento, Italy. Paul Matejtschuk Paul Matejtschuk (BSc, PhD, CChem, FRSC) is a Principal Scientist, and lead the Standardization Science Section in the Analytical & Biological Head of Process, Purification and Sciences Division at the National Institute for Biological Standards & Control (NIBSC), a centre of the Medicines and Healthcare products Regulatory Agency , whose mission is to safeguard the quality of biological medicines. NIBSC is also designated a WHO International Laboratory for Biological Pharma Development, Biopharma Standardization. National Institute for Biological His team is focused on delivering formulation and lyophilization conditions for a wide range of biological reference materials and research interests Standards and Control, include the relationship between structure and stability in biologicals, thermal analysis and methods for the characterization of lyophilized proteins. Medicines & Healthcare products Paul has 35 years postdoctoral experience working in both academia and industry in the areas of biologicals, has co-authored many peer- Regulatory Agency, UK reviewed papers and has broad experience across downstream processing, formulation and characterization. He is a Director of the International Society for Lyophilization/Freeze Drying (www.islyophilization.org), membership officer of the Thermal Methods Group of the Royal Society of Chemistry (www.thermalmethodsgroup.org.uk) and in 2019 co-edited with Dr Kevin Ward “Lyophilization of Pharmaceuticals & Biologicals - New Technologies & Approaches for Springer Humana Press ( https://link.springer.com/book/10.1007%2F978-1-4939-8928-7) Dr. Sune Klint Andersen Dr. Andersen is a principal scientist in spray drying and enabling technologies at Janssen Research & Development, Belgium. He has an MBA in Principal Scientist DPD – management & technology and a PhD in chemical engineering, with a specialization in nanoparticle technology. His main interests and experience include the development of drying processes for drug products, drug substances, intermediates, excipients for both R&D and industrial scale Oral Solid Dosage purposes, application of quality-by-design in drying processes, validation and qualification of spray dryers, advantages & disadvantages of spray vs Janssen, BE freeze-drying processes, continuous manufacturing, and enabling technologies for drug products. www.qepler.com +420 608 030 490 register@qepler.com
PHARMACEUTICAL LYOPHILIZATION SUMMIT 2021 SPEAKER’S BIOGRAPHIES Andrea Weiland, Ph.D. Andrea Weiland, Ph.D., is managing director of Explicat® Pharma GmbH, a company providing technical project management services and Managing Director pharmaceutical development services to the Pharmaceutical Industry (CMC). Andrea is a pharmacist with a Ph.D. in pharmaceutical technology on biodegradable microspheres and cyclodextrins . She held several leadership Explicat Pharma GmbH, DE positions within Pfizer, working as project manager in process technology and within R&D where she was responsible scientist for pharmaceutical development (Phase I - III, candidate characterization and lyophilisation projects). Diego Zurbriggen Mr. Zurbriggen has over 20 years of analytical lab experience, 10 of which focused on inorganic trace level analysis. As Technical Account Manager Technical Account Manager within the Technical Customer Support group of West, the focus of his role is to provide technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. He serves as the West subject matter expert on Extractables & Leachables, West Pharmaceutical Services, including elemental impurities. USA Prior to this role, he was Supervisor of the Leachables/Stability group in the Analytical Labs division of West Pharmaceutical Services, Inc., the focus of his role was to develop and validate leachables methods. Mr. Zurbriggen holds a Bachelor of Science/Chemistry degree from the Gewerbliche Berufsschule Visp – Visp, Valais, Switzerland. Jean René Authelin Jean René Authelin has an Engineer degree in chemical Engineering from ENSIC (Nancy France), and a PhD from The Institut National Polytechnique Global Head of Pharmaceutical de Lorraine (France). He joined Rhone Poulenc in 1988 as a Chemical Engineer. In the 90’s he founded the Physical Quality function, dedicated to the API crystallization , drying, polymorphism… for which he was for 10 years Global Head in Rhone Poulenc Rorer, Aventis and finally sanofi . In, 1988 Engineering JR Authelin was nominated Global Head of Pharmaceutical Engineering. Domains of interest of JRA include: thermodynamics of hydrates, drug Sanofi-Aventis, FR polymorphism, amorphous solids physics, drug stability, crystallization, nanoparticles engineering and processing, drying , milling; spray drying, fluid bed granulation, roller compaction, freeze drying. Jean René Authelin is the author or co-author of 20 publications or book chapters and the co-inventor of 9 patents. Roman V. Loretts With his radio engineering background Roman started back in Russia as Senior Advisor at the Trade Council, being part of the Ministry of Foreign Regional Manager Affairs of Denmark. Relocating to Denmark in 2011, Roman engaged with ELLAB for development and support of life science customers within CEE region. He personally visited top pharmaceutical companies in 25+ countries for exchanging knowledge and experience within thermal validation ELLAB A/S, DK field. Roman is regular speaker at PDA, ISPE, WFHSS, C&VS and other specialized events, arranging customer training programs and webinars, responsible for localization and registration of ELLAB products and currently focusing on activities within markets of India, Russia, and Turkey. After acquiring Hanwell Monitoring solutions in 2019, Roman has been deeply involved into integration of monitoring products within Ellab Group as well. www.qepler.com +420 608 030 490 register@qepler.com
REGISTRATION FORM This registration form is editable. When you have completed the form - please save and email it to register@qepler.com SUMMIT NAME: VIRTUAL - 3rd Annual Pharmaceutical Lyophilization Summit 2021 REGISTRATION DATE: PACKAGE NAME Standard price Individual ticket - 1st Day (29th July 2021) - (*includes 1st Day’s post-event conference materials distribution) €195 Individual ticket - 2nd Day (30th July 2021) - (*includes 2nd Day’s post-event conference materials distribution) €195 Individual ticket - 2 Days - (*includes complete post-event conference materials distribution) €295 Group ticket - 2 Days (*2-3 delegates) - (*includes complete post-event conference materials distribution) €215 Group ticket - 2 Days (*4+ delegates) - (*includes complete post-event conference materials distribution) €145 Documentation package - (*if you have no plans to join the live conference) €395 Promotional materials distribution €445 SPEAKER SPONSOR - €995 PARTNER SPONSOR - €1295 GOLD SPONSOR - €1695 CONFERENCE MATERIALS: All participation tickets, already contains complete conference materials distribution package, including - slides, list of participants, stream and video recording. You don’t need to order an additional «Documentation Packages». Documentation package will be sent to the attendees within 72 hours after the event. The presentation content is subject to speaker’s companies approval for distribution. ATTENDEE DETAILS 1ST ATTENDEE 2ND ATTENDEE 3RD ATTENDEE 4TH ATTENDEE 5TH ATTENDEE 6TH ATTENDEE Title: Name: Surname: Company: Country: Job Title: Direct phone: Email: Special Requirenments: (If you have any special dietary requirements or other needs that would enhance your enjoyment of this summit, please specify) INVOICE DETAILS: Title: Name: Surname: Job Title: Direct Phone: Mobile: Email: Company: Country: City: EU VAT #: Address: Postcode: Payment Method: Bank Transfer Credit Card Pay Pall TERMS & CONDITIONS: REGISTRATION & PAYMENT Upon receiving the signed registration form, we will process your application. The registration confirmation and the invoice will be sent to you within one (1) working day with the relevant payment instructions and terms. The registration fee includes access to all sessions and conference materials. Payment is due 14 working days from the invoice date. Payment should be made by Credit Card, Pay Pall or by Bank Transfer. The delegate is responsible for any bank charges/fees associated with the payment. CANCELLATION & SUBSTITUTION POLICY You may substitute a delegate at any time and at no extra cost. Cancellations must be in a written notice. Cancellations made 30 days or more before the event start date will be refunded less than 50% of the registration fee. Cancellations made less than 30 days before the event start date will receive no refund. If you cannot attend an event due to illness or other unforeseen circumstances, you may transfer your delegate pass to another upcoming event within one year from original event start date. EVENT CHANGES & CANCELLATIONS While all effort will be made to adhere to the advertised package, Qepler s.r.o. reserves the right to change event dates, sites or location, omit event features, or merge the event with another event as it deems necessary without penalty. In such situations no refunds, part refunds or alternative offers will be made. In the event that Qepler s.r.o. permanently cancels the event for any reason, and provided that the event is not postponed to a later date nor is merged with another event, you will receive a credit note or refund for 100% of the conference fee paid. Please note, Qepler s.r.o. will not be held liable for any accommodation or associated travel costs should the event be canceled or rescheduled. DATA PROTECTION The personal information provided by you will be held in the Qepler database. It may be used to infrom you about other Qepler products and services. Unless you click here , your details may be made available to third parties for marketing purposes. For data update please write to databasemanager@qepler.com. Signature: ✍ «I agree to be bound by Terms and Conditions of registration» ✍ SEND www.qepler.com +420 608 030 490 register@qepler.com © All rights reserved Qepler s.r.o. 2020
PARTICIPATION PACKAGES ONLINE PACKAGES: PACKAGE NAME PRICE DOCUMENTATION (*if you have no plans to join the live conference) Post-event presentations with video records, list of participants and other materials. €395 If you are unable to attend, you The presentation content is subject to speaker’s companies approval for distribution. may purchase these packages PROMOTIONAL MATERIALS DISTRIBUTION Distribution of your company’s promotional materials to all attendees €445 SPONSORSHIP PACKAGES: SPEAKER PARTNER GOLD BENEFITS €995 €1295 €1695 Number of passes included 1 2 3 Registration fee for additional company representatives €195 €145 €95 Link to Landing Page/Video Presentation trough the live event translation. ● ● Link to Virtual Exhibition Page trough the live event translation. ● Opening keynote presentation 15 min Speaking slot 20 min 30 min 30 min Workshop slot 40 min Recognition in chairman’s opening address ● ● Opening & closing speech ● Chairman of Day 1 ● Chairman of Day 2 ● Logo and URL on summit website, agenda and pre/post-summit communication activities ● ● ● Recognition on Qepler social media channels (LinkedIn/Facebook/Twitter/Instagram) ● ● ● Color advert placed on agenda 1/2 Page 1 Page Online distribution of your company’s promotional materials to all attendees ● ● MARKETING CAMPAIGN ▸Website ▸Email Marketing ▸Digital Advertising ▸Social Marketing ▸Press ▸Direct Sales PARTICIPATION FEE Fees are inclusive of the complete summit materials, online post-event documentation/presentation package, list of participants, video records, and certificate of participation. TRANSLATION The event translation link will be announced online and sent to the delegates within a reasonable period before the summit start date. POST-EVENT DOCUMENTATION Presentations and other materials will be sent to the attendees within 72 hours after the event. The presentation content is subject to speaker’s companies approval for distribution. DISCOUNTS Early booking discounts are not valid in conjunction with any other offers. ◀ WAYS TO REGISTER www.qepler.com +420 608 030 490 register@qepler.com
EVENTS CALENDAR Please choose the Summit / Summits and send us suggested Session Title via email or webpage. 2021 We will appreciate if you share our calendar with your colleagues! CLICK HERE TO REQUEST INFORMATION PHARMA - MEDICAL DEVICES - CHEMISTRY 2nd Genotoxic Impurities in Pharmaceuticals Summit ................................................................................................................................. July 15-16, 2021 ● VIRTUAL CONFERENCE GTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities. https://qepler.com/pdf/v2gti21.pdf AGENDA WEB REGISTRATION IS OPEN 3rd Annual Pharmaceutical Lyophilization Summit ...................................................................................................................................... July 29-30, 2021 ● VIRTUAL CONFERENCE Discuss best practices in tech & regulatory updates, process, formulation, testing, monitoring, new products development. DRUG DELIVERY - FORMULATION - R&D - DEVICES - COMBINATION PRODUCTS - PFS - LYOPHILIZATION - E & L - IMPURITIES - HPAPI - https://qepler.com/pdf/v3lyo21.pdf AGENDA WEB REGISTRATION IS OPEN 2nd Annual Inhaled Drug Delivery Summit ................................................................................................................................................... August 5-6, 2021 ● VIRTUAL CONFERENCE Assess and harness novel approaches to the development of inhaled drug products for enhanced patient care. https://qepler.com/pdf/v2idd21.pdf AGENDA WEB REGISTRATION IS OPEN 3rd Annual Highly Potent APIs Summit ........................................................................................................................................................ October 7-8, 2021 ● VIRTUAL CONFERENCE Assess and reduce manufacturing and handling challenges for highly potent active pharmaceutical ingredients. https://qepler.com/pdf/v3hpapi21.pdf AGENDA WEB REGISTRATION IS OPEN 3rd Annual Extractables & Leachables Summit ....................................................................................................................................... October 20-21, 2021 ● VIRTUAL CONFERENCE Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility. INHALATION - ASEPTIC PROCESSING - MDR - CMC - QRM - PFS - DDC - EM https://qepler.com/pdf/v3el21.pdf AGENDA WEB REGISTRATION IS OPEN 3rd Annual Drug/Device Combination Products Summit ...................................................................................................................... December 2-3, 2021 ● VIRTUAL CONFERENCE Get up to date with the regulatory and quality compliance strategies for combination product development. https://qepler.com/pdf/v3ddcp21.pdf AGENDA WEB REGISTRATION IS OPEN CONTACTS Please send your session title and summit name to: Denis Polikarpov Executive Director Tel: +420 608 030 490 Email: denis.polikarpov@qepler.com Evgenia Makar CEO Tel: +420 770 699 211 Email: evgenia.makar@qepler.com www.qepler.com +420 608 030 490 register@qepler.com © All rights reserved Qepler s.r.o. 2021
You can also read
