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The SMi Group is pleased to invite you to the 5th Annual Lyophilization USA Conference arranged to take place on the 23rd and 24th October 2019, in Boston.
The current list of FDA-approved biopharmaceuticals contains up to 50% of injectables and approximately a third of all parenterals being lyophilized, which suggests it is the optimal way of ensuring stability in products that are unstable in aqueous solution. This instability or degradation can result in suboptimal product performance and even toxicity in worst cases indicating the need for lyophilization despite it’s inherently expensive running costs and time-consuming process.
However, despite being a relatively old process, there is much need for improvements to circumvent the high costs and extended process times with much room for innovation. Next year’s projections for the lyophilization equipment market are approximately $5.7 billion, which is 8% CAGR. This surge is fuelled by the urge to perfect lyophilization processes in areas that characterise the product to better inform formulation and process developments while consequently improving efficiency and reducing capital investment.
Join us this year to explore novel and developing technologies that tackle the most pressing challenges and push innovation in world of lyophilization. Benchmark and network with industry leaders and discuss the most up to date and relevant topics that delve into alternative lyophilization approaches, applied statistical modelling, fresh views on scaling up and tech transfer, pre- and post-product characterization. regulation and beyond.
 


 Participating in this year’s SMi Group Lyophilisation USA 2019 conference provides a chance to connect with research and industry leaders with the aim of tackling the most pressing hurdles in multiple areas of interest within lyophilisation:
- Gain valuable insight into the most current challenges and considerations when working with highly concentrated and sensitive formulations
- Explore new and innovative approaches in model-based studies that utilise the power of statistical analysis to improve process development and understanding
- Discuss the future outlook of lyophilization through trends in alternative approaches
- Discover updates on the leading PAT technologies such as controlled nucleation, continuous freeze drying, low-frequency Raman, vacuum-foam drying and more.
- Listen to key opinion leaders and experts from regulatory bodies speak about expectations and the assessment of reliable technologies in the market
 

VPs, Directors, Chiefs, Heads, Principals, Managers and Analysts of:
• Lyophilization/Freeze-drying
• Formulation Scientists
• Principal Scientist
• Process Development/Engineer
• Sterile/Fill-Finish
• Production
• PAT
• CMC
• Chemistry
• Manufacturing
• Quality Assurance/QA

Amatisgroup; Arlenda; Aznil Telstar Technologies, SLU; Abbott Healthcare Products BVá; BioNTech; Baxter SA; Bayer A G; Biofire Diagnostics; Biopharma Group; BioPharma Technology; Boehringer Ingelheim; Boehringer-Ingelheim; Bristol-Myers Squibb; BSP PHARMACEUTICALS Srl; BUCHI UK Ltd ; DeMontford University; DSM; Ferring Pharmaceuticals A/S; Fresnius Kabi Austria GmbH; F. Hoffman-La Roche Ltd.; GEA Process Engineering; Genzyme Ireland Ltd; GlaxoSmithKline; GlaxoSmithKline plc; GSK; GSK Manufacturing S.p.A.; Hosokawa Micron BV; Imperial College London; LFB Technology; INDATECH SAS; Janssen Pharmaceutica NV; MedImmune; MedImmune Inc.; Merck KGaA; Mylan; NIBSC; Novo Nordisk; OPTIMA pharma GmbH; Pacifi Ltd; Pfizer Inc; Pliva Croatia Ltd; RheaVita BV; Roche; Roche Pharmaceuticals; Sandoz GmbH; Syngenta Limited; TEVA Pharmaceuticals; University College Cork (UCC); University Of Central Lancashire; University of Ghent; Vetoquinol SA; Xellia Pharmaceuticals ApS;
 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Evgenyi Shalaev

Evgenyi Shalaev, Executive Director, Allergan Plc
View Bio

9:10 A new model to investigate the growth of ice crystals and dynamics of freeze concentration in bulk protein solutions

Tai Hsi  Fan

Tai Hsi Fan, Associate Professor , University of Connecticut
View Bio

• Understand the issue of redistribution and segregation of proteins between ice crystals during freezing resulting in a negative impact on protein stability
• Introducing a new phase-field model that examines the morphology, transport mechanisms, and interplay behind solute exclusion from ice crystals, high viscosity of the solution and limited space between crystals
• Interpretation of results, computational method, and further development across spatial and temporal scales
 

9:50 Mass Spectrometer as process analytical tool and silicon oil detector

Alexander Tambovzev

Alexander Tambovzev, Project Engineering and Development Leader, OPTIMA pharma GmbH
View Bio

• Mass spectrometer is powerful and well known technology
• Unfortunately, the usage of it in freeze drying is often limited only by silicon oil leakage detection during system leak test
• Integration the mass spectrometer in entire freeze drying process as additional measurement equipment can extend process understanding and improve process quality control
 

10:30 Morning Coffee

11:00 Role of water in (in)stability of freeze-dried products: beyond molecular mobility concept

Evgenyi Shalaev

Evgenyi Shalaev, Executive Director, Allergan Plc
View Bio

• Water is a major factor which influences stability of lyophilized proteins
• In addition to plasticizing effects, water can cause deterioration of freeze-dried proteins via catalysis of deamidation and other chemical reactions
• Water can also be a protein stabilizer, by preventing dehydration-induced changes in the higher-order structure
 

11:40 Preventing Cross Contamination during Lyophilization

Richard Denk

Richard Denk, Head Sales Containment, Skan
View Bio

• What are highly potent/toxic Biopharmaceutical Products
• What are the GMP and Occupational Safety Requirements
• How to prevent Product Contamination during loading the Lyo
• Cleaning Requirements and Occupational Safety Requirements
 

12:20 Networking Lunch

13:20 Spray freeze-drying – Next Generation Drying Technology

Fawziya Ali

Fawziya Ali, Senior Associate Scientist, Pfizer
View Bio

• Lyophilization, the gold standard drying technology, has several limitations such as lengthy drying durations and low energy efficiency
• Spray freeze-drying presents a promising alternative drying technology that can be utilized for biologics
• Experiences from lab and large-scale spray freeze-drying experiments will be discussed in this talk
 

14:00 Vial breakage during Lyophilization – Mechanisms and Case studies

Ekneet Sahni

Ekneet Sahni, Senior Process Development Scientist, Pfizer
View Bio

• Why is it hard to translate same breakage rates on laboratory scale from commercial scale
• Elucidating vial breakage mechanisms during lyophilization cycle optimization using strain gauges
• Discuss breakage stress testing of vials
 

14:40 Continuous Lyophilization of Unit Doses

Bernhardt Trout

Bernhardt Trout, Professor of Chemical Engineering, MIT
View Bio

• New fully continuous approach to lyophilization in vials
• Bench scale data to inform design in a variety of model products
• Substantial savings in time and resources, plus flexibility
 

15:20 Afternoon Tea

15:50 Alternative Drying Technologies to Enable Semi-Continuous Manufacturing

Justin Stanbro

Justin Stanbro, Associate Principal Scientist, Merck & Co.
View Bio

• Review the current state of lyophilization alternatives
• Introduce microwave vacuum drying: fundamentals and advantages
• Discuss compatibility of microwave vacuum drying to sensitive biologics and vaccines
• Explore opportunities to synergize microwave vacuum drying with other new approaches, such as bulk drying and alternative Drug Product images
 

16:30 Predictive modeling for lyophilization equipment characterization, process scale-up and technology transfer

Ehab Moussa

Ehab Moussa, Senior Scientist, AbbVie, Inc.
View Bio

• Experimental and computational approaches to characterize lyophilization equipment
• Approaches to measure the product resistance of the formulation
• Considerations for process scale-up and technology transfer
 

17:10 Chairman’s Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Madhushree Gokhale

Madhushree Gokhale, Principal Scientist, Bristol Myers Squibb
View Bio

9:10 Utilizing Raman Spectral Changes to Predict Lyophilized Protein Stability

Lauren Fontana

Lauren Fontana, Principal Scientist , Sanofi
View Bio

• Development of a Raman spectroscopic method to detect secondary and tertiary structural changes in proteins in solution or solid state
• Application of the Raman method to screen protein formulations for stability rank order due to structural changes during the lyophilization process or storage
• Evaluation of the method benefits, limitations and potential applications for future use
 

9:50 Quality by Design Approach to Development of a Lyophilized Multidose Vaccine

Sara Yazdi

Sara Yazdi, Senior Scientist, Takeda Vaccines

• Critical process parameters for lyophilized vaccines
• Excipient Impact
• Development of a multidose format
 

10:30 Morning Coffee

11:00 Crystallization and other phase transitions during freeze-drying: why we need to understand, and how to monitor

Evgenyi Shalaev

Evgenyi Shalaev, Executive Director, Allergan Plc
View Bio

• Crystallization is the most common liquid/solid phase transition, while formation of micelles and crystalline mesophases can also take place during freeze-drying
• Crystallization of excipients and/or active ingredients (e.g., PEG in PEGylated proteins) could have a major impact on the yield and stability of freeze-dried products
• Various laboratory-based and PAT-related methods to monitor phase transitions are discussed
 

11:40 Lyophilization Process Optimization, Tech transfer and Scale-up Challenges for Drug Product Manufacturing

• Lyophilization Process Optimization is critical for improving process efficiency without impacting drug product quality
• Scale-up of lyophilization process from lab or pilot scale lyophilizer to commercial lyophilizer is a major challenge for successful tech transfer
• Various approaches for improving lyophilization process efficiency will be presented. Also, technical considerations for scale-up of freeze drying process will be discussed in this talk
 

Swapnil Pansare

Swapnil Pansare, Principle Scientist, Bristol-Myers Squibb Co
View Bio

12:20 Networking Lunch

13:20 A new approach to lyophilization process development and transfer enabled by equipment characterization and process modeling

Fabrice Schlegel

Fabrice Schlegel, Senior Engineer, Amgen
View Bio

• Development: Predict a virtual characterization space representative of all equipment scales.
• Scale-up / tech transfer: Leverage process model to drastically reduce number of runs at full scale.
• Manufacturing: Use first principle model as soft sensor to predict product temperature in real time in commercial manufacturing.
 

14:00 Controlled Ice Nucleation – Investigating the impact of nucleation technique, formulation, and product properties on process performance

Chakradhar Padala

Chakradhar Padala, Director, Amgen
View Bio

• Impact of controlled nucleation on lyophilization cycle times for varying fill volumes & formulation types
• Case study comparing two different controlled nucleation techniques, and their impact on process performance & quality attributes
• Is annealing an alternative to controlled nucleation for process performance?
• Business considerations for technology selection, and implementation at a manufacturing plant
 

14:40 Afternoon Tea

15:10 Continuous monitoring of sublimation rate for individual containers in freeze drying processes

Pouya Tavousi

Pouya Tavousi, Postdoctoral Fellow, University Of Connecticut
View Bio

• Negating the need for conventional gravimetric measurements
• Providing more accurate measurements than TDLAS
• Introducing minimal disturbance to the freeze drying process
• Facilitating data acquisition for recipe design
 

15:50 Formulation Development Strategy to Stabilize Lyophilized Protein Drug Product

Charlie Tang

Charlie Tang, Director,áFormulationáDevelopment, Regeneron Pharmaceuticals, Inc.
View Bio

• Understand the requirement of target drug product profile at different stages of product development
• Develop a stable lyophilized formulation to meet initial clinical requirement
• Implement formulation and lyophilization strategies to maximize product stability
• Develop a lyophilized Drug Product for potential room temperature storage
 

16:30 Chair’s Closing Remarks and Close of Day Two

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FEATURED SPEAKERS

Alexander Tambovzev

Alexander Tambovzev

Project Engineering and Development Leader, OPTIMA pharma GmbH
Bernhardt Trout

Bernhardt Trout

Professor of Chemical Engineering, MIT
Charlie Tang

Charlie Tang

Director,áFormulationáDevelopment, Regeneron Pharmaceuticals, Inc.
Ekneet Sahni

Ekneet Sahni

Senior Process Development Scientist, Pfizer
Evgenyi Shalaev

Evgenyi Shalaev

Executive Director, Allergan Plc
Fabrice Schlegel

Fabrice Schlegel

Senior Engineer, Amgen
Fawziya Ali

Fawziya Ali

Senior Associate Scientist, Pfizer
Lauren Fontana

Lauren Fontana

Principal Scientist , Sanofi
Pouya Tavousi

Pouya Tavousi

Postdoctoral Fellow, University Of Connecticut
Richard Denk

Richard Denk

Head Sales Containment, Skan
Sara Yazdi

Sara Yazdi

Senior Scientist, Takeda Vaccines
Tai Hsi  Fan

Tai Hsi Fan

Associate Professor , University of Connecticut

Alexander Tambovzev

Project Engineering and Development Leader, OPTIMA pharma GmbH
Alexander Tambovzev

Alexander Tambovzev, received Ph.D. in refrigeration technology in technical university of Dresden in 2008 with a focus on modeling of dynamic processes. He was working in research and development area of refrigeration systems for commercial and industrial applications. Currently he is a project engineering and development group leader at Optima pharma, Germany. The area of his responsibility is leading the project engineering of the freeze dryers as well as the R&D effort in the freeze dryer technology.

Bernhardt Trout

Professor of Chemical Engineering, MIT
Bernhardt Trout

Bernhardt L. Trout is the Raymond F. Baddour, ScD, (1949) Professor of Chemical Engineering at MIT. His research focuses on the development of advanced manufacturing processes and rational tools for liquid and lyo formulation and product design. In 2007, with several colleagues from MIT, he set up the Novartis-MIT Center for Continuous Manufacturing, a $85 million partnership with the objective of transforming pharmaceutical manufacturing. He has recently collaborated with Roberto Pisano of the Polytechnic University of Turin on continuous lyophilization, the subject of this talk. In addition, he is Co-Chair of the International Symposium on Continuous Manufacturing of Pharmaceuticals. He has published over 200 papers and has 22 patents issued or pending.

Chakradhar Padala

Director, Amgen
Chakradhar Padala

Chakradhar Padala, Ph.D. is a Director in Amgen Process Development, with more than 11 years of experience in drug product process design, scale-up, and tech transfers to manufacturing sites. He led a number of Amgen products from early stage through commercial filing and has authored multiple regulatory filings. As part of process development, he now leads a team of engineers & scientists responsible for developing and integrating next generation technologies into drug product manufacturing plants. He is also a Lyophilization subject matter expert at Amgen, and is a member of industry consortia, working on establishing best practices.

Chakradhar received his Ph.D. in Chemical & Biological Engineering from Rensselaer Polytechnic Institute (NY), working on understanding the interaction of proteins with lipid bilayer systems. He has published seven research publications in peer reviewed journals, scientific book chapters, and presented at many scientific conferences.
 

Charlie Tang

Director,áFormulationáDevelopment, Regeneron Pharmaceuticals, Inc.
Charlie Tang

Charlie (Xiaolin) Tang is a Director in Formulation Development at Regeneron Pharmaceuticals Inc. He received his Ph.D. in pharmaceutics from University of Connecticut, specialized in freeze drying technology. He is the co-inventor of “Smart Freeze-Dryer” (with Dr. Michael Pikal and Steven Nail). His current research interests are in early and late phase protein formulation development for liquid & lyophilized drug products, lyophilization process development and technical transfer to manufacture sites.

Ehab Moussa

Senior Scientist, AbbVie, Inc.
Ehab Moussa

Ehab Moussa obtained his PhD in Pharmaceutics from Purdue University where he focused on the lyophilization and spray drying of monoclonal antibodies. He is currently a senior scientist in drug product development at AbbVie Inc. where he is responsible for the formulation and manufacturing process development of biotherapeutic drug products.

Ekneet Sahni

Senior Process Development Scientist, Pfizer
Ekneet Sahni

Ekneet did her PhD in Pharmaceutics from University of Connecticut in Powder flow behavior for different unit operations and pursued her Postdoc at University of Connecticut with Dr. Michael Pikal. Currently, Ekneet is an Ass. Principal Scientist in Manufacturing Science & Technology division at Pfizer. In her present role she supports Lyophilization cycle optimization/troubleshooting, Scale-up and commercial products transfer activities, Commercial products investigation, Lyophilizer characterization & mathematical modeling.

Evgenyi Shalaev

Executive Director, Allergan Plc
Evgenyi Shalaev

Evgenyi Shalaev, Ph.D., AAPS Fellow, is an executive director in Biological Products Development, Allergan, California, USA, and an adjunct professor in the Department of Pharmaceutics, University of Minnesota. He held the Royal Society Fellowship in Pafra Biopreservation and the University of Cambridge, UK, post-doctoral research appointments at the University of Wisconsin-Madison and Cornell University, and worked at the Institute of Carbon (Russia), Institute of Molecular Biology (Russia), and Pfizer Inc. (USA). Dr Shalaev’s research interests include: amorphous solids; phase transitions in aqueous systems; stability of pharmaceuticals; freeze-drying. He has published over a hundred peer-reviewed papers, book chapters, and patent applications.

Fabrice Schlegel

Senior Engineer, Amgen
Fabrice Schlegel

Fabrice Schlegel, Ph.D., is a mechanical engineer relying on first principles to understand and solve engineering problems, especially those involving fluid flow, heat transfer and mass transport. Fabrice has a Masters in applied mathematics and scientific computing from the MATMECA Engineering School (Bordeaux, France) and a Masters and Ph.D. in Mechanical Engineering from MIT. Before Joining Amgen, Fabrice was an applications engineer and team leader at COMSOL Inc, the multiphysics simulation software company.
As part of the Digital Integration and Predictive Technologies (DIPT) team at Amgen, he drives the development and deployment of computational models across the product lifecycle, to achieve the best patient experience. Fabrice has managed and completed several key projects with process development, spanning the spectrum of the drug substance, drug product, device and development supply chain verticals.
 

Fawziya Ali

Senior Associate Scientist, Pfizer
Fawziya Ali

Fawziya Ali is a Senior Associate Scientist at Pfizer working in the Pharmaceutical Research and Development Group. She has 5 years of experience supporting formulation and process development of early and late stage liquid and lyophilized biologics. Fawziya is part of the Pfizer Lyo Technologies team, undertaking lyophilization process development activities, with a focus on spray freeze-drying process development. Fawziya Ali graduated with a BS in Chemical and Biological Engineering from MIT.

 

Justin Stanbro

Associate Principal Scientist, Merck & Co.
Justin Stanbro

Justin Stanbro is an Associate Principal Scientist at Merck., where he has worked for 16 years. He received a B.S. in Biomedical Engineering from Rutgers University and an M.S. in Chemical Engineering from Lehigh University. For eight years, Justin supported the upstream and downstream clinical manufacture of both vaccines and therapeutic proteins. For the last six years, Justin has been evaluating new technologies in the Vaccine Drug Product Development Group, including Microwave Vacuum Drying as an alternative to Lyophilization and other novel drying approaches.

 

Lauren Fontana

Principal Scientist , Sanofi
Lauren Fontana

Lauren joined the Sanofi R&D Lyophilization Center of Excellence within the Global Biological Drug Product Development (BioDPD) team in May 2019. Lauren recently defended her doctorate in Pharmaceutical Sciences at the University of Connecticut, where she was advised by Dr. Robin Bogner. For her dissertation research, she developed a Raman spectroscopic method to detect secondary and tertiary structural changes in proteins in the solid state. The goal was development of a structural analysis tool for use in formulation development, process development and stability studies. Prior to UConn, Lauren spent 15 years in the pharmaceutical industry as a chemist working in various areas, including development of analytical methods and medical devices, as well as, formulation and process development for lyophilized protein drug products.

 

Madhushree Gokhale

Principal Scientist, Bristol Myers Squibb
Madhushree Gokhale

Madhushree Gokhale got her Ph.D in Pharmaceutics from the University of Iowa in the area of chemical kinetics and drug degradation. She is currently an Associate Director at Bristol Myers Squibb, NJ in the Drug Product Science and Technology Group. She has over 13 years of experience and leads a group in the formulation/process development space working with biologics and small molecule parenteral product development. Prior to her current role she also has extensive experience with oral small molecule product development. She is also an active member of AAPS.

 

Pouya Tavousi

Postdoctoral Fellow, University Of Connecticut
Pouya Tavousi

Pouya Tavousi is currently an Assistant Professor at the Central Connecticut State University. He received his Bachelor’s degree in Aerospace Engineering in 2010 from Sharif University of Technology in Tehran, Iran. He then moved to US and received his PhD in Mechanical Engineering in 2016 from the University of Connecticut. Throughout his research career, he has focused on the development of state-of-the-art algorithmic approaches for addressing one of the most challenging science problems, namely characterization and understanding the behavior of nanoscale biological systems as well as design, fabrication and manipulation of such systems. He has developed new techniques and computational and physical tools for studying nanosystems and the related manufacturing processes.

Richard Denk

Head Sales Containment, Skan
Richard Denk

Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Head Containment. Mr. Denk founded 10 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the ISPE Containment Manual Mr. Denk was responsible for in September 2015. He is Member of the ISPE SIG BioTech Group in Europe and Steering Committee Member of the ISPE SPP (Sterile Product Processing) CoP. Furthermore Mr. Denk founded the PDA Expert Group about Cleaning and Cross Contamination Requirements for Biopharmaceutical Products and published this topic as PDA Paper. Mr. Denk is co Autor of the ISPE OSD Baseline Guide Volume 2 and Volume 3. Mr. Denk has spent 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.

Sara Yazdi

Senior Scientist, Takeda Vaccines
Sara Yazdi

Swapnil Pansare

Principle Scientist, Bristol-Myers Squibb Co
Swapnil Pansare

Mr. Swapnil Pansare is Principle Scientist at Bristol-Myers Squibb and in his current role, he is Drug Product (DP) tech transfer lead interfacing with R&D and internal sites or CMO’s for new & commercialized product development teams. Swapnil has 10 years of experience in DP manufacturing, fill-finish, scale & tech transfer and Formulation development. He is a key member of Parenteral MS & T group, currently supporting tech transfer of commercial products to commercial sites. In his previous role, Mr. Pansare was responsible for lyophilization process optimization, scale-up & tech transfer for freeze-dried products. He has received his MS in pharmaceutical sciences from Northeastern University.

 

Tai Hsi Fan

Associate Professor , University of Connecticut
Tai Hsi  Fan

Tai-Hsi Fan is an associate professor in the Department of Mechanical Engineering at University of Connecticut. He received his PhD in Mechanical Engineering from Georgia Tech and was a postdoctoral fellow at Max-Planck-Institute for Polymer Research in Germany before joining UConn. His research interests are in theoretical analysis and computation of multiphase flows, phase transition dynamics, and thermal manufacturing processes.

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Sheraton Boston Hotel

39 Dalton Street, Boston, MA, USA

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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Lyophilization USA 2019 Attendees

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Interview with Timothy McCoy at Sanofi

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Interview with Fabrice Schlegel, Amgen

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2018 Infographic

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Lyophilization USA Previous Attendee List

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Interview with Lauren Fontana from Sanofi

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Challenges of Lyophilized Products Development

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Another View of the Freeze Dryer Design Space -

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Interview - Richard Denk, SKAN AG

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Speaker Interviews 2019

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Vacuum foam drying of biotherapeutics - Alex Langford, Pfizer

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Speaker list 2019

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Lyophilization 2019 Brochure

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Lyophilization USA 2019 Workshop Programme

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Lyophilization 2019 Programme

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Optima

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Optima Pharma develops and manufactures filling, sealing and process technology for pharmaceutical products. Freeze drying systems and isolator technology are part of turnkey systems by Optima Pharma. The product range includes machinery for laboratory filling up to high-speed systems. Optima Pharma is a member of the OPTIMA packaging group GmbH.

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Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy

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Lyophilization World is a global platform in the field of lyophilization and freeze drying technology. Follow us to be informed in a unique way about current solutions, future trends and news in lyophilization


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IPI – International Pharmaceutical Industry IPI – was established to fill in the void for effective marketing and communication between all stakeholders in the Life sciences sector globally. Edited by our carefully selected editorial advisory panel, and extensive research network, IPI provides a proven supportive means of communication to the pharmaceutical, bio pharmaceutical, nutraceutical and medical devices industry the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies which will enable them to be more efficient, bring products to market faster, reduce cost and make healthcare accessible to all.

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Sheraton Boston Hotel

39 Dalton Street
Boston 02199
USA

Sheraton Boston Hotel

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
Registered in England No: 3779287 VAT No: GB 976 2951 71




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