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SAE Media Group’s 11th Annual Conference
Pharmaceutical Microbiology Europe
January 16 - 17, 2023 |   London, UK
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SAE is proud to present the 11th Annual Pharmaceutical Microbiology UK Conference in January 2023.

Microbiology is an essential tool for the detection of microorganisms present in biopharmaceutical and drug product manufacture. The field of pharmaceutical microbiology has seen a rapid growth in recent years, this has been in part due to the introduction of alternative, rapid microbiological methods, and the application of automated approaches to microbiology. Together these have provided faster, clearer, and superior data, significantly improving the operational efficiency of laboratories. Alongside these new technologies ever changing regulations such as the impending release of Annex 1 and a globalised aseptic world have meant that the industry is having to re-think many of  the most basic principles.

This conference will explore the most pressing topics in this thriving field, from the movement toward process automation and reduction in operator-product interaction, to the latest technologies in rapid microbiological testing methods and data integrity. The agenda will highlight insightful case studies across these themes, uncovering key developments and the future of pharmaceutical microbiology.

 

This two-day agenda offers you peer-to-peer networking with industry experts and representatives from leading pharmaceutical companies and is the perfect opportunity to maximise the impact of your microbiology labs.

  • Optimise your contamination control strategy with a look-back on the initial impact of Annex 1 with sessions from Sanofi , AbbVie, Fresenius Kabi and more
  • Learn how to utilise the latest microbiological methods to modernise your contamination control strategy
  • Maximise the data output from your environmental and microbial monitoring with proven strategies and technologies
  • Increase the diversity of your testing methodologies through industry case studies including recombinant factor C and Raman Spectroscopy assays

 

  • Heads of Microbiology
  • Heads of Aseptic Processing
  • Global Quality Directors
  • Heads of GMP Compliance
  • Quality & Compliance Heads
  • Microbiology Senior Specialists
  • Directors of Quality Control Biology
  • Quality Control Managers
  • Quality Assurance Managers
  • Lean Managers
  • Operations Managers
  • Heads of Site Compliance
  • Heads of Sterile Technology
  • Global Microbiology Analytical Experts
  • Cleanroom Managers
  • Regulatory Affairs Managers
  • Production Managers
  • Quality Systems Managers

Previous attendees include:

3dimension Cleanrooms Limited; ADMA Biologics; Amgen; Astra Zeneca; AstraZeneca; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim Pharma GmbH & Co.KG; CATAPULT; Charles River EMD; CTL-MAT, LLC; Ecolab Life Sciences; Eli Lilly Italia S P A; Eli Lilly Italia SpA; EUROPAI Uk Ltd; F Ziel GmbH and PHSS; Franz Ziel GmbH; Fresenius Kabi AB; GSK; GSK Vaccines; Jazz Pharmaceuticals; MeiraGTx; Microgenetics; Microgenetics Ltd; Novatek Europe; Novo Nordisk; Oxford BioMedica; Paul Ehrlich Institut; PharmaCircle LLC; Roche Diagnostics Gmbh; Sanofi; STERIS Corporation; Teva; TEVA Runcorn;

Conference programme

8:00 Registration & Coffee

9:00 Chairman's Opening Remarks

9:10 The transition in Pyrogen- and Endotoxin Testing

Ingo Spreitzer

Ingo Spreitzer, Deputy Head, Paul Ehrlich Institut
View Bio

  • Pros and Cons of the current testing strategies
  • “Alternative” approaches using the MAT and rFC
  • Regulations, Requirements and Guidelines
  • Considering the future of the field
  • 9:50 Replacing traditional Viable EM Methods for Air in Grade A by

    Kurt Jaecques

    Kurt Jaecques, Senior Manager Sterility Assurance, Global Quality, GSK

  • Brief explanation of the RMM technology of Biofluorescent Particle Counting
  • Explaining the pros & cons of this technology compared to culture-based EM
  • Sharing a first pilot project on a commercial RABS filling line + learnings
  • Sharing feedback from regulators on the implementation strategy
  • 10:30 Morning Coffee

    11:00 Monocyte Activation Test- Identifying Innate Immune Response

    Sophia Pfeiffer

    Sophia Pfeiffer, Scientist, Boehringer Ingelheim Pharma GmbH & Co.KG
    View Bio

    • Challenges of pyrogen detection
    • Proof of Concept of cryopreserved PBMC based MAT
    • Case study of IIRMI detection
    • Conclusion

    11:40 Maximising the Output of Automated Environmental Monitoring

  • Optimising EM with automation and RMM
  • Increasing your understanding your facilities risk with RT monitoring
  • Maximising data integrity with Automated Environmental Monitoring 
  • Practical and profitable reasons to employ automated EM
  • Jan-Jaap Schot

    Jan-Jaap Schot, Associate Director- Site Microbiology Lead, MSD

    12:20 “Know it before you Grow it” - Next level automated Environmental Monitoring

    Johannes  Oberdörfer

    Johannes Oberdörfer, Field Application Scientist, Rapid Micro Biosystems Inc

  • Regulatory requirements on species detection with new Annex 1 and USP
  • The past, present and the future of mould and fungi detection in Environmental monitoring testing
  • Application validation and detection performance
  • 12:50 Networking Lunch

    13:50 Data Integrity – Challenges in microbiology testing

    Di Morris

    Di Morris, Clinical Development Auditor, AstraZeneca
    View Bio

  •  First principles of data integrity, assurance of data consistency and  accuracy throughout its life cycle
  • Definitions, five essential concepts explained – Assuring data is Attributable, Legible, Contemporaneous, Original, and Accurate
  • Focus: Handling qualitative and quantitative Microbiological data,
  • How to avoid Issues in data integrity
  • 14:30 The Pharmaceutical Microbiologist Panel Discussion

  • Recruiting and retaining pharmaceutical microbiologists in the biopharma industry.
  • The role of the pharmaceutical microbiologist on the shop floor and in investigations.
  • Mentoring and providing incentives for the pharmaceutical microbiologist in the industry
  • Developing a pipeline of pharmaceutical microbiologists for the industry
  • Jim Polarine Jr.

    Jim Polarine Jr., Senior Technical Service Manager, STERIS Corporation
    View Bio

    Alexander Stoll

    Alexander Stoll, Vice President, Head of Competence Center Microbiology and Aseptic Techniques, Fresenius Kabi
    View Bio

    Lindsey Silva

    Lindsey Silva, Director Microbiology, Genentech
    View Bio

    15:10 Afternoon Tea

    15:40 Endotoxin detection challenges associated with the development of a novel VLP

    Callum Scott

    Callum Scott, Technical Transfer and Formulations Development Manager, Allergy Therapeutics UK
    View Bio

    • Development challenges associated with virus-like particles and endotoxin
    • Pyrogen detection strategy for a novel VLP
    • Compliance and regulatory considerations
    • Use of a monocyte activation test (MAT)
     

    16:20 rFC Implementation Strategy for Endotoxin Testing

    Lindsey Silva

    Lindsey Silva, Director Microbiology, Genentech
    View Bio

  •  Minimising animal product usage with Recombinant technologies
  •  Reviewing the compendia and regulatory standpoint for rFC
  •  Validation considerations for implementation of rFC as the primary bacterial endotoxin method
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    9:10 Transformations in Contamination Control Strategies by Annex 1

    James L Drinkwater

    James L Drinkwater, Head of GMP compliance and Aseptic Processing support, Franz Ziel GmbH
    View Bio

  • Applying the revised ICHQ9 QRM principles to a CCS and consideration on Life cycle strategies 
  • CCS implementation experiences following publication of Annex 1 – Case study examples
  • New GMP requirements that make take longer to implement than the default period and how to manage these challenges.
  • Areas where clarity of regulatory expectations still need interpretation to apply in a CCS.
     
  • 9:50 Analysis of the first months of Annex 1 for audit readiness

    Nigel Cryer

    Nigel Cryer, Deputy Director Quality Audits, Sanofi

  • Strategic approaches to analysing your compliance
  • Overcoming challenges that Annex 1 have presented
  •  Ensuring compliance with correct preparation
  •  Improving constantly- How to stay ahead of regulatory changes in the future
     
  • 10:30 Morning Coffee

    11:00 How to Implement Annex 1 in the Drug Substance World - A Consensus

    Paul Osborne

    Paul Osborne, Global Project Manager , BioPhorum

  • Understanding the differences in guidance and principles for annex 1 application to sterile drug product manufacture and low bioburden drug substance.
  • How best to utilise the Annex 1 guidance where it can be applied to low bioburden biologic intermediates
  • Maximising product quality and patient safety with by ensuring Annex 1’s correct interpretation
  • 11:40 A discussion on the impact of Annex 1 since publication, benchmarking across the industry

  •  Successes Annex 1 how implementation has improved contamination control
  • Challenges faced during initial implementation period 
  • Delving into the impact in Annex 1 has had
  • Moving forward, what are the next steps before final compliance?
  • James L Drinkwater

    James L Drinkwater, Head of GMP compliance and Aseptic Processing support, Franz Ziel GmbH
    View Bio

    Nigel Cryer

    Nigel Cryer, Deputy Director Quality Audits, Sanofi

    Di Morris

    Di Morris, Clinical Development Auditor, AstraZeneca
    View Bio

    12:20 Networking Lunch

    13:20 The revised Annex 1 – a manufacturers perspective

    Alexander Stoll

    Alexander Stoll, Vice President, Head of Competence Center Microbiology and Aseptic Techniques, Fresenius Kabi
    View Bio

  • Monitoring (draft) Annex 1 requirements throughout the consultation processes
  • Defining a globally harmonized concept for the Contamination Control Strategy (CCS)
  • How preparation efforts did support global implementation
  • Surprises and/or new elements in the final version?
  • 14:00 Optimising water monitoring with online water bioburden analysis

    Peter Annel

    Peter Annel, Principal Scientist, Novo Nordisk
    View Bio

  • Implementation and validation of online analysis systems
  • Overcoming challenges with the technology
  • Case Study of Novo Nordisk’s water bioburden monitoring
  • Future outlook for water bioburden analysis systems
     
  • 14:40 Afternoon Tea

    15:10 Strengthening Microbial Control Strategies for CGT manufacture

    Vicky Stoyel

    Vicky Stoyel, Senior QA Officer, Oxford BioMedica
    View Bio

  • Complying with GMP regulations for CGT manufacture
  • Differences to be considered for CGT manufacture vs traditional Methods
  •  Developing a specific CCS for CGT manufacture
  • Optimizing microbial control from a QRM perspective
  • 15:50 A Contamination Control Strategy Approach in ATMP Cleanrooms

    Jim Polarine Jr.

    Jim Polarine Jr., Senior Technical Service Manager, STERIS Corporation
    View Bio

  • How to control hard to proactively prevent contamination from viruses, spores and vegetative bacteria
  • Recent case studies from the past few months in cell and gene therapy and compounding pharmacies will be discussed in relation to incubators and pass thru decon
  • Published data will also be covered to convey effective methods in control bioburden into the cleanrooms and BSCs
  • This presentation well be a holistic approach to controlling bioburden from entering cleanrooms and BSCs
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Alexander Stoll

    Alexander Stoll

    Vice President, Head of Competence Center Microbiology and Aseptic Techniques, Fresenius Kabi
    Callum Scott

    Callum Scott

    Technical Transfer and Formulations Development Manager, Allergy Therapeutics UK
    Di Morris

    Di Morris

    Clinical Development Auditor, AstraZeneca
    Ingo Spreitzer

    Ingo Spreitzer

    Deputy Head, Paul Ehrlich Institut
    James L Drinkwater

    James L Drinkwater

    Head of GMP compliance and Aseptic Processing support, Franz Ziel GmbH
    Jim Polarine Jr.

    Jim Polarine Jr.

    Senior Technical Service Manager, STERIS Corporation
    Lindsey Silva

    Lindsey Silva

    Director Microbiology, Genentech
    Nigel Cryer

    Nigel Cryer

    Deputy Director Quality Audits, Sanofi
    Peter Annel

    Peter Annel

    Principal Scientist, Novo Nordisk
    Sophia Pfeiffer

    Sophia Pfeiffer

    Scientist, Boehringer Ingelheim Pharma GmbH & Co.KG
    Vicky Stoyel

    Vicky Stoyel

    Senior QA Officer, Oxford BioMedica

    Alexander Stoll

    Vice President, Head of Competence Center Microbiology and Aseptic Techniques, Fresenius Kabi
    Alexander Stoll

    Born in Germany, Alexander completed his PhD thesis in Microbiology in 2001. After moving to Sweden, he started working for Fresenius Kabi sterile international manufacturing plant in Uppsala. Throughout the years Alexander has been holding different management positions for the Swedish manufacturing plants within QA/QC and as QP. Starting 2012 he had responsibility as a Global Operations QA head, with regional QA and plant QA functions reporting to him. In his current position as VP Competence Center Microbiology & Aseptic Technique he has built a group of subject matter experts working with all manufacturing and compounding sites, setting global standards.

    Callum Scott

    Technical Transfer and Formulations Development Manager, Allergy Therapeutics UK
    Callum Scott

    Callum holds a PhD in Molecular Microbiology from Heriot-Watt University. Following a Post-Doctoral Research Fellowship and period as a lecturer in Applied Science, he moved into industry as Vaccine Development Manager with Benchmark Animal Health Ltd. Since 2020, Callum has been a Technical Transfer and Formulations Development Manager with Allergy Therapeutics (UK) Ltd.

    Di Morris

    Clinical Development Auditor, AstraZeneca
    Di Morris

    Di is qualified with MRSC Chemistry and Post Graduate Diploma Industrial Pharmaceutical Science and is a Qualified Person under permanent provisions since 1993.
    Di has worked in the pharmaceutical industry for over 40 years this includes a number of years as a Medicines Inspector for the MHRA. Di has worked in the areas of Quality Control (Chemistry and Microbiology), Quality Assurance, Regulatory Affairs and Compliance Auditing and has worked with a wide range of dosage forms including sterile products, biological, and non-sterile dosage forms.
     

    Ingo Spreitzer

    Deputy Head, Paul Ehrlich Institut
    Ingo Spreitzer

    My former research topics (Lectins) and immune-activating components of bacteria introduced me to preparation /purification and bioassays, which until today influences my work on immune-activating / pyrogenic substances. I started at the PEI 2001 with the development and validation of the Monocyte activation test (MAT).
    My current duties as deputy at the PEI are drug QC by LAL (all methods) and Pyrogen testing (former rabbit pyrogen test, now replaced by MAT) and scientifically the exploration of the MAT. Our actual interests are drugs with intrinsic pyrogenicity, Outer membrane vesicles, synergistic effects and low Endotoxin recovery (LER).
     

    James L Drinkwater

    Head of GMP compliance and Aseptic Processing support, Franz Ziel GmbH
    James L Drinkwater

    Ex-Chairman, honorary member of the PHSS: Pharmaceutical and Healthcare Sciences Society, a Not-For-Profit educational platform for GxP and current leader of PHSS special interest groups on Aseptic processing and Biocontamination. PHSS Co-lead of Annex 1 revision (sterile medicinal product manufacturing) focus group and Contamination Control Strategy (CCS) Guidance initiative. James is also the current Head of GMP Compliance at Franz Ziel GmbH and actively involved In Pharmaceutical, Biologics and ATMP product manufacturing projects. Based in the UK James has a global support role.

    Jan-Jaap Schot

    Associate Director- Site Microbiology Lead, MSD
    Jan-Jaap Schot

    Jim Polarine Jr.

    Senior Technical Service Manager, STERIS Corporation
    Jim Polarine Jr.

    Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active on the PDA’s COVID-19 Task Force and the PDA’s Microbial Excursions Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators with FDA, MHRA, HPRA, ANVISA, and ANMAT as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

    Johannes Oberdörfer

    Field Application Scientist, Rapid Micro Biosystems Inc
    Johannes  Oberdörfer

    Kurt Jaecques

    Senior Manager Sterility Assurance, Global Quality, GSK
    Kurt Jaecques

    Lindsey Silva

    Director Microbiology, Genentech
    Lindsey Silva

    Lindsey Silva

    Director Microbiology, Genentech
    Lindsey Silva

    Lindsey Silva, Ph.D. is a Director, Microbiology in Analytical Sciences at Genentech, a Member of the Roche Group. Our team is responsible for driving QC network analytical innovation and QC microbiology solutions. Dr. Silva was previously responsible for virus clearance studies and development of virus testing technologies to ensure viral safety of biologics. Dr. Silva received her Bachelor of Science in Biology from UC Irvine and Ph.D. in Microbiology and Molecular Genetics from Harvard Medical School. Committed to diversity and inclusion, Dr. Silva co-leads the SACNAS professional chapter at Genentech and is a board member of the non-profit ADDSTEAM.

    Nigel Cryer

    Deputy Director Quality Audits, Sanofi
    Nigel Cryer

    Paul Osborne

    Global Project Manager , BioPhorum
    Paul Osborne

    Peter Annel

    Principal Scientist, Novo Nordisk
    Peter Annel

    DVM in 1983. worked with microbiology since 1984. With Novo Nordisk since 1996, principal scientist since 2004. Worked in micro-QC, API production and product development, providing support and troubleshooting to micro-labs and API and FP production departments on microbial issues as well as training in general microbiology, aseptic behaviour etc.
    Member of EDQM group 1, Microbiology, since 2011.
     

    Sophia Pfeiffer

    Scientist, Boehringer Ingelheim Pharma GmbH & Co.KG
    Sophia Pfeiffer

    As Lead Scientist in the Microbiology Group at Boehringer Ingelheim Biberach, Sophia is responsible for screening, selection and successful implementation of state-of-the-art technologies in microbiology routine labs. Her main task is to drive the transformation of the labs in terms of automation, innovation and digitalization. Sophia has worked across multiple disciplines along her career including Research and Development, Quality Control and Microbiology. Sophia holds a Master’s Degree in Pharmaceutical Biotechnology by the University of Ulm, Germany.

    Vicky Stoyel

    Senior QA Officer, Oxford BioMedica
    Vicky Stoyel

    Vicky Stoyel qualified as a Microbiologist from Bristol University and worked in this field for several years. She eventually became a Site Microbiologist working with sterile, radioactive pharmaceuticals. More recently she has moved to Oxford Biomedica in a Quality Assurance role and is involved in project delivery. She is currently working on a new filling isolator for ATMPs and responsible for contamination controls.

    Sponsors

    Exhibitors

    Supporters

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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.
    HOTEL BOOKING FORM

    Preliminary Attendees List

    Download

    Speaker Interview - Alexander Stoll - Fresenius Kabi

    Download

    Speaker Interview - Jim Polarine - Steris

    Download

    Past Attendees List

    Download

    Brochure

    Download

    Short Programme

    Download

    Full Programme

    Download

    Conference Co-chair Letter

    Download

    Sponsors


    Rapid Micro Biosystems

    Sponsors
    http://www.rapidmicrobio.com

    Rapid Micro Biosystems is an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products such as biologics, vaccines, cell and gene therapies, and sterile injectables. The company’s flagship Growth Direct® platform automates and modernizes the antiquated, manual microbial quality control (MQC) testing workflows used in the largest and most complex pharmaceutical manufacturing operations across the globe. The Growth Direct® platform brings the quality control lab to the manufacturing floor, unlocking the power of in-line/at-the-line MQC automation to deliver faster results, greater accuracy, increased operational efficiency, better compliance with data integrity regulations, and quicker decision making that customers rely on to ensure safe and consistent supply of important healthcare products. The company is headquartered and has U.S. manufacturing in Lowell, Massachusetts, and global locations in Switzerland, Germany, and the Netherlands.

    Exhibitors


    Associates of Cape Cod

    Exhibitors
    https://www.acciusa.com/products-and-services/

    Associates of Cape Cod, Inc. (ACC) has been a global leader in endotoxin and (1?3)-ß-D-glucans detection products and services for more than 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents; ACC has grown to be an internationally recognized leader in endotoxin detection

    With almost 50 years of experience, ACC is best placed to offer an additional level of service to labs already performing the test, as well as set companies up to test for endotoxin and glucans in-house from start to finish.

    At ACC we are at the forefront of sustainability and conservation efforts when it comes to endotoxin testing. As part of this effort, we have developed the world’s first fully recombinant LAL technology. You can find out more about our sustainability efforts here. Or if you wish to find out more about our products and services please contact technicalsupport@acciuk.co.uk



    Cherwell

    Exhibitors
    http://www.cherwell-labs.co.uk.

    Cherwell Laboratories Ltd is a UK manufacturer and supplier of the prepared media Redipor®. The Head Office is in Bicester, Oxfordshire and can boast an excellent transport network, which enables its abilities to work effectively with the Export and Distribution partners as well as all Domestic customers.

    With over 50 years’ experience, Cherwell has become a specialist supplier of ‘cleanroom microbiology solutions’ with products for environmental monitoring and process validation for healthcare, pharmaceutical and industrial applications.

    Because environmental monitoring is a critical element to any manufacturing process, Cherwell focuses on supplying high quality, reliable products, that are supported by expert knowledge. The range within the product portfolio enables professionals to make informed decisions about their cleanroom environment, and sterility processes. Which allows them to select the best suited solutions for them to manage risk associated with a robust contamination control strategy.

    The SAS air environmental sampling range is reliable and robust equipment known to conform to the Annex 1 requirement of 1m³.

    The new ImpactAIR is designed for high-risk graded environments, deploying a monitoring innovation that is called ‘slit to agar’. This system uses a Redipor 9cm plate rather than the standard 14cm. The process provides assurances on potential contamination within the cleanroom environment with a D50 value of 0.53 micron capturing the extremely small-scale particles, complying with the Annex 1 requirements

    We work in partnership within the market and take pride in sharing our knowledge, experience and expertise to ensure that everyone is using our portfolio in the best way possible for their environmental needs and expectations.



    Microgenetics

    Exhibitors
    https://www.microgenetics.co.uk/

    Environmental monitoring can be time-consuming and is open to risks, including data duplication and transcription errors. That’s why at Microgenetics, we’ve developed SmartControl as a new way for you to capture, manage and track your data, making your lab paperless, efficient and smart.

    SmartControl makes it easy for users to meet regulation, enhance data integrity and take better environmental monitoring decisions. It’s compliant with FDA 21 CFR Part 11 and GMP Annex 11, yet simple to use. Booking in a plate takes just 6 seconds, with in-depth analysis and reporting at your fingertips.

    Plus, it’s easy to set up. Being a cloud-based software, testing and validation is completed by Microgenetics and there’s no physical server installation. This means you could have the software running in your facility in just 6 weeks. Any subsequent updates – whether this means new and improved features, or updates in line with new regulation - are also hassle-free, too.

    Are you ready to bring your lab into the future?



    NPC Limited

    Exhibitors
    http://www.naughtonpenn.com

    NPC provides services and products to the Scientific Industry, in particular the Pharmaceutical Industry. Professional Training Services in performance and techniques. Our product portfolio includes: Prepared Culture Media from PMM and QC Microorganisms from ielab. We offer a unique Environmental Monitoring software solution, SherpaPharma, a totally paperless system.


    Media Partners


    Contract Biotechnology

    Supporters
    http://www.contract-biotechnology.com

    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. It is an online R&D matching tool that connects Scientifics and service and product providers worldwide. The platform Contract-Biotechnology.com would help you in the process of finding the right partner saving time and money, because with one single and secure application you would be able to receive multiple quotes quickly, keeping your contact information confidential. Contract-Biotechnology.com is the new Collaboration Network Model for Discovery Research and Development. Contract-Biotechnology.com team has extensive experience working for pharmaceuticals, biotechs, universities and academic research institutes and can help you addressing your key gaps.


    Genetic Engineering News

    Supporters
    http://www.genengnews.com

    Genetic Engineering & Biotechnology News (GEN) is the most authoritative and widely read biotechnology news publication in the world.Published 21 times a year,GEN's unique news and technology focus include the entire bioproduct life cycle from early-stage R&D to applied research and bioprocess through to commercialization. GEN is the only publication that provides the full range of the biotechnology market coverage in areas such as omics, drugs and biomarker discovery, bioprocessing, clinical research, molecular diagnostics and biobusiness. For a free subscription go to: http://www.genengnews.com/subscriptions.aspx


    SciDoc Publishers

    Supporters
    http://www.scidoc.org

    SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.


    World Pharma News

    Supporters
    http://www.worldpharmanews.com/



    Rapid Microbiology.com

    Supporters
    https://www.rapidmicrobiology.com

    rapidmicrobiology.com is a well-established on-line resource for microbiologists worldwide, find the right products for your microbiology lab using our specially designed search functions. To keep up-to-date with the latest microbiology news get our free weekly newsletter which includes updates on products, services, webinars, training courses and conferences.


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    IPI

    Supporters
    http://www.ipimediaworld.com

    IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.


    Farmavita

    Supporters
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    American Pharmaceutical Review

    Supporters
    http://www.americanpharmaceuticalreview.com

    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


    MedTube

    Supporters
    https://medtube.net/



    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


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    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


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    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Pharmavision

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    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


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    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    Drug Discovery Today

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    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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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, SAE Media 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@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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