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Pharmaceutical Microbiology
22 January - 23 January 2018
Pharmaceutical Microbiology

SAE Media Group proudly presents the 7th Annual Pharmaceutical Microbiology Conference, in London, on the 22nd and 23rd of January 2018.
The pharmaceutical microbiology industry is ever expanding; with increasing need for rapid, more efficient microbial methods and regulations being updated and revised.
Join us to discuss and address the evolving issues facing this industry, such as: the assurance of sterility and aseptic practice within clean rooms, data integrity, quality control and regulatory updates, to name a few. Hear from speakers at the forefront of the field and gain insight into the processes of key regulatory bodies.
 

FEATURED SPEAKERS

Francesco  Boschi

Francesco Boschi

Site Quality Assurance Manager, Pfizer
Olivier Chancel

Olivier Chancel

Sterility and Aseptic Process Assurance Expert , Boehringer Ingelheim
Renate Rosengarten

Renate Rosengarten

Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna
Ruth Daniels

Ruth Daniels

Senior Scientist, Microbiology Expert, janssen pharmaceutical
Shahram Lavasani

Shahram Lavasani

CEO, ImmuneBiotech AB

Andrew Bartko

Research Leader, Battelle Memorial Institute
Andrew Bartko

Benoit Ramond

Senior Microbiology Expert, Sanofi
Benoit Ramond

Benoît Ramond is a Doctor in Pharmacy at the University of Paris IX in France had has obtained a PhD in Microbiology. He has more than 28 years experience in the Pharmaceutical industry. He has been a microbiology expert at the Sanofi group and is the Head of Microbiology and Sterile Technologies, since 2016. He also has a leading role in RMM and Environmental Monitoring strategy development within Sanofi.

Christine Farrance

Director of Research and Development, Charles River Laboratories
Christine Farrance

Felix Montero-Julian

Scientific Director, Biomerieux
Felix Montero-Julian

Felix, is a Scientific Director of the Health and Personal Care Business of bioMerieux. Felix has over 22 years of experience in industrial and clinical diagnostics and previously served as the Chemunex R&D Director in Biomerieux. Félix graduated from the Autonomous Metropolitan University in Mexico as Industrial Biochemistry Engineer and obtained a PhD in Immunology from the Aix Marseille II University in France. Felix is a member of different scientific organizations (PDA, ISAC) and served as an expert in a panel for rapid microbiology technologies for the USP. Félix has been and continues to be extensively involved in the implementation and acceptance of rapid and alternative microbiological methods. He is a prominent speaker at congresses and conferences and a regular contributor to bioMérieux whitepapers.

Francesco Boschi

Site Quality Assurance Manager, Pfizer
Francesco  Boschi

Dr. Francesco Boschi studied Biology at the University of Milan and obtained his post-doc Degree in Applied Biotechnology in 1997. He initially joined an R&D Group in Milan University performing research activities focused on the development of fermentation processes of industrial interest by genetically engineered yeast strains. Then, after different working experiences in the area of industrial microbiology and sterility assurance (Pharmacia & Upjohn, Patheon, Eli Lilly, GSK) and prior to join his current Company, he was Quality Assurance Manager in the Cortemaggiore (Italy) Site of Doppel Farmaceutici and Project Leader for all the projects involving new products submitted in the U.S. market. His current position (since 2017) is Quality Assurance Manager in the Catania (Italy) Site of Pfizer Global Supply (PGS). Dr. Boschi has presented training seminars and lectures both in national and international Events related to microbiology and pharmaceutical manufacturing.

Ingo Spreitzer

Deputy head Section Microbial safety, Paul Ehrlich Institut
Ingo Spreitzer

James Drinkwater

Chairman, Head of Aseptic Process Technologies & GMP Compliance, PHSS, F Zeil GmbH
James  Drinkwater

James Drinkwater is Head of Aseptic processing technologies & GMP compliance for F Ziel Germany, supporting international projects from a base in the UK. As a subject matter expert in Barrier separation technology; Isolator / RABS and hydrogen peroxide vapour bio-decontamination, James is involved in applications of sterile pharmaceutical product Filling, Aseptic processing of APIs/ ATMPs and Sterility testing.
In addition to the role at F Ziel James has a voluntary role as Chairman of the not for profit society: PHSS – Pharmaceutical and Healthcare sciences society and leads the PHSS Aseptic processing & Bio-contamination special interest group.
 

Jean Reyes

Microbiology Lab Manager, Boehringer Ingelheim
Jean Reyes

Jeremy Webb

Professor of Microbiology, Principal Investigator Biofilms and Microbial Communities, University Of Southampton
Jeremy Webb

Jeremy Webb is Professor of Microbiology at University of Southampton, UK. He has received a series of competitive fellowship awards from The Australian Research Council, the UK Leverhulme Trust, and BBSRC for work on the physiology, antimicrobial resistance, evolution, and molecular genetics of biofilms and polymicrobial communities. His work includes the discovery of nitric oxide as a regulator of biofilm dispersal, which is now being exploited for therapeutic applications in cystic fibrosis, including the first human clinical trial for a biofilm-targeted therapeutic. Current research also seeks to identify genes that undergo adaptive evolution during bacterial biofilm development.

Jim Cannon

International Thornton Pharmaceutical Manager, Mettler-Toledo Thornton Inc
Jim Cannon

Jim Cannon is Head of OEM and Markets at Mettler-Toledo Thornton, he has a B.S. in Biology, degrees in Microbiology and Biophysics, and an MBA in Marketing and International Management.
Mr Cannon has over 35 years of experience in the management, design and development of ultrapure water treatment and technology. This includes measuring differential conductivity and UV oxidation for the detection of TOC in UPW and the design and commercialisation of electrodeionisation modules.
Mr Cannon is currently involved in the standards and regulatory organisations for the Semiconductor, Photovoltaic and Pharmaceutical markets, and the commercialisation of alternative microbial technology.

Jim Polarine

Senior Technical Service Manager, STERIS Corporation
Jim Polarine

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for sixteen years. His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. 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 as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. He is a member of the PDA’s Environmental Monitoring Group, Contamination Control Group, and Biotech Interest Group. He is president elect with the PDA Missouri Valley Chapter. He is part of the faculty at the University of Tennessee Parenteral Medication course. He is also active with the IEST Special Topics Committee on Cleaning and Disinfection. He has presented at key industry venues for NASA, USP, PDA, ISPE, FDA, SIMB, GBPR, IPA, AALAS, IVT, IEST, University of Tennessee, SWE, STERIS Applied Sterilization Technologies, and Barnett International on cleaning and disinfection, disinfectant validation, and contamination control. Mr. Polarine frequently presents global industry webinars on Cleaning and Disinfection for several industry seminar circuits including Compliance Online, STERIS, and Executive Conferences. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology, and is a member of the PDA, SIMB, ISPE, IEST, ASM, ASTM, AAAS, AOAC, and ACS. 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.

Kai Nesemann

Global Product Manager Rapid Detection, Sartorius Lab Instruments GmbH & Co. KG
Kai Nesemann

Karin Nordgren

Head of the Pyrogen Science Group, The National Institute for Biological Standards and Control (
Karin Nordgren

Olivier Chancel

Sterility and Aseptic Process Assurance Expert , Boehringer Ingelheim
Olivier Chancel

Patrick Nieuwenhuizen

Sterility Assurance Lead, Sanofi
Patrick Nieuwenhuizen

Patrick Nieuwenhuizen, BSc Microbiology / Immunology
Quality Control Manager with over 20 years of experience in the industry working for a numerous international pharmaceutical (biotech) companies with specialties in microbiology, validation and aseptic controls and assurance. Co-author of the microbiology module Pharmaceutical Technician for EduFarma and given numerous presentations on other training courses on pharmaceutical microbiology and aseptic assurance & control.
 

Renate Rosengarten

Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna
Renate Rosengarten

Renate Rosengarten’s academic career is for almost 40 years marked by a continuous interest in the infection biology of mycoplasmas, and their detection, prevention and control. Her passion for mycoplasmas took her to the University of Veterinary Medicine Hannover, the University of Missouri-Columbia and the Hadassah Medical School of the Hebrew University in Jerusalem. Since 1996 she is Professor and Chair of Bacteriology and Hygiene at the University of Veterinary Medicine Vienna in Austria. Besides her numerous activities in academia, Prof. Rosengarten was the Founder and Managing Director of the previous niche market leader Mycosafe Diagnostics GmbH which she has as Managing Partner in 2014 re-established under the new company name Mycoplasma Biosafety Services GmbH. The company is considered today as the technological innovation leader in the area of Industrial Mycoplasmology.

Robert Porzio

Product Manager, Lonza QC Testing Solutions
Robert Porzio

Robert Porzio is a Product Manager for Endotoxin Detection at Lonza, with a primary focus on instrumentation and software. Robert brings 20 years of endotoxin experience with him having worked at Charles River and Associates of Cape Cod in production, marketing and sales. During his time at Associates of Cape Cod, Robert has also gained European experience as he worked three years in Germany performing marketing and sales for Pyroquant Diagnostik GmBH, the German ACC subsidiary. During the past four years Robert set-up his own endotoxin testing distribution company where he sold the Hyglos rFC and Wako endotoxin reagents amongst others. His background is in microbiology at Johnson & Johnson has been a huge benefit in understanding endotoxin detection systems and actualizing the needs of the industry into the future. Robert is a graduate from the College of Charleston and holds a degree in Biology and Psychology.

Ruth Daniels

Senior Scientist, Microbiology Expert, janssen pharmaceutical
Ruth Daniels

Ruth Daniels holds a Master degree in Bioscience Engineering from the Catholic University of Leuven (Belgium) and obtained her PhD in Applied Biological Sciences in 2002 at the same university. After an academic career, she started in 2011 at Genzyme (Sanofi Belgium) as Lead Microbiology Operational Technical Support and Manufacturing Science. Ruth joined the Janssen R&D microbiology department as Senior Scientist in 2015. She has a broad expertise in the field of endotoxin and pyrogen testing and is involved in multiple Janssen clinical development programs as microbiology expert. Ruth is a member of BPOG Low endotoxin recovery Group, and PDA Low endotoxin recovery task force.

Shahram Lavasani

CEO, ImmuneBiotech AB
Shahram Lavasani

Shahram Lavasani holds a PhD degree from Lund University (Sweden), in Medical Inflammation Research where he studied the immunoregulation and novel immunotherapies in multiple sclerosis (MS). He is a skillful immunologist with many years of research expertise on gastrointestinal complications in chronic inflammatory diseases. Focusing on Gut-Brain axis he has pioneered research in MS by demonstrating increased intestinal permeability and design of therapies targeting the gut microbiota. He is the founder of ImmuneBiotech, developed a proprietary lactobacilli library and established careful and multiple selection methods to screen and design formulations for the optimal therapeutic management of the diseases.

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Opening Remarks & Introductions

Benoit Ramond

Benoit Ramond, Senior Microbiology Expert, Sanofi

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9:10

Regulation Overview

Benoit Ramond

Benoit Ramond, Senior Microbiology Expert, Sanofi

  • Pharmacopoeias
  • FDA Requests
  • PDA Technical Report No67
  • Scientific Articles
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    10:00

    General Information on:

    Benoit Ramond

    Benoit Ramond, Senior Microbiology Expert, Sanofi

  • What should be a microorganism of concern?
  • Why to evaluate?
  • Who is responsible?
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    10:40

    Morning Coffee

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    11:10

    Method of evaluation of microorganisms

    Benoit Ramond

    Benoit Ramond, Senior Microbiology Expert, Sanofi

  • How to determine of a microorganism is of concern/ objectionable?
  • Application to non-sterile products
  • What about sterile products?
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    11:55

    Practical application with Burkholderia cepacia complex

    Benoit Ramond

    Benoit Ramond, Senior Microbiology Expert, Sanofi

    Preparation of a risk assessment with the following key points:

  • Product/ Process Risk Evaluation
  • Microorganism Risk Evaluation
  • Patient Risk Evaluation
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    12:30

    Closing Remarks

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    13:30

    Registration & Coffee

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    14:00

    Chairman's Opening Remarks

    Andrew Bartko

    Andrew Bartko, Sr. Research Scientist, Battelle

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    14:10

    Commercially off-the-shelf options

    Andrew Bartko

    Andrew Bartko, Sr. Research Scientist, Battelle

  • Microbial contamination detection
  • Microbial contamination identification
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    14:50

    Technical aspects of sensing

    Andrew Bartko

    Andrew Bartko, Sr. Research Scientist, Battelle

  • Fidelity of results
  • Actionable limits
  • Time to result/ action
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    15:30

    Afternoon Tea

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    16:00

    Implementation of strategies

    Andrew Bartko

    Andrew Bartko, Sr. Research Scientist, Battelle

  • Comparability to standard methods
  • Return on investment
  • Risk reduction advantages
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    16:40

    Validation pitfalls to avoid

    Andrew Bartko

    Andrew Bartko, Sr. Research Scientist, Battelle

  • Viable but not curable
  • Approaches to regulatory approval
  • Case studies
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    17:20

    Chairman’s Closing Remarks and Close of Day One

    Andrew Bartko

    Andrew Bartko, Sr. Research Scientist, Battelle

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Olivier Chancel

    Olivier Chancel, Sterility and Aseptic Process Assurance Expert , Boehringer Ingelheim

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    9:10

    How the development of Mycoplasma testing could potentially revolutionise quality control

    Renate Rosengarten, Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna

    • Mycoplasma testing and why it is important
    • Culture detection methods vs nucleic acid detection
    • Different methods of Mycoplasma testing
    • Current regulations surrounding Mycoplasma testing

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    9:45

    Fungal and bacterial spores and spore contamination control

    Patrick Nieuwenhuizen, Sterility Assurance Lead, Sanofi

    • Current regulations surrounding sporicides and disinfectants
    • How can we control spore contamination levels in cleanrooms?
    • Case studies of effective spore control practice
    • Improved methods of determination of contamination
    • Outcomes of New England Compounding Pharmacy

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    10:20

    Morning Coffee

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    10:50

    Creating a Culture of Data Integrity

    Felix Montero-Julian, Scientific Director, Biomerieux

    • Data Integrity should compliance with ALCOA
    • Data Integrity shouldn’t be looked at in an isolated way. But should follow the data during the whole process.
    • Integrate useable audit trails, multiple user ID levels, automated reports and connectivity, good archiving.
    • Data integrity needs to be the integrated workflow of the Data management eco-system

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    11:30

    Microbiome therapies & the regulatory issues surrounding the development of this field

    Shahram Lavasani, CEO, ImmuneBiotech AB

    • The gut microbiome and its potential as a target for disease treatment
    • The recent developments of microbiome therapies
    • The regulatory issues surrounding the development of these therapies
    • How to circumvent these issues and encourage advancement within the field

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    12:05

    Importance of Data Integrity When Testing for Endotoxin

    Robert Porzio, Product Manager, Lonza QC Testing Solutions

  • Data Integrity Basics and Corporate Governance
  • Benefits of Quantitative Methods for Endotoxin Detection
  • Data Integrity components through WinKQCL™ Endotoxin Detection & Analysis Software
  • Establishing a Risk Based Approach to your Review Process through Audit Trails and establishing a failure mode and effects analysis
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    12:45

    Networking Lunch

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    13:45

    Rapid Detection of Bacteria in ATMP prior treatment – Validation of a qPCR-based test

    Kai Nesemann

    Kai Nesemann, Global Product Manager Rapid Detection, Sartorius Lab Instruments GmbH & Co. KG

  • Contaminated ATMPs constitute life-endangered risks for treated patients that are most often immunocompromised
  • A reliable microbial release test is indispensable prior to treatment to ensure patient safety. Current International pharmacopeia stipulate a duration of 14 days for sterility testing. Typically, ATMPs have a shelf-life of less than 48 hours
  • ATMPs cannot be released by current traditional methods prior to treatment. The risk of administering potentially contaminated ATMPs urges industry and authorities to find solutions for rapid releases
  • For the first time, a rapid testing system based on qPCR has been developed to detect total bacterial contamination within only 3 hours prior to treatment. This study shows the validation approach according to EP 5.1.6., EP 2.6.27 and USP<1223>
     
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    14:25

    Flow cytometry technology and its applications

    Jean Reyes

    Jean Reyes, Microbiology Lab Manager, Boehringer Ingelheim

    • Overview of the applications in Microbiology
    • Counting bacteria: In line and fast tool
    • Characterization of Ag

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    15:00

    Afternoon Tea

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    15:30

    Developing requirements in microbiological control and monitoring and Impact from revision of EU GMP Annex 1

    James Drinkwater, Chairman, Head of Aseptic Process Technologies & GMP Compliance, PHSS, F Zeil GmbH

  • PHSS/ Industry perspective on impact of EU GMP Annex 1 revision.
  • Prescriptive GMP versus flexibility to apply GMP and ORM principles in environmental control and monitoring.
  • Environmental Control by design and microbiological monitoring taking a more holistic approach.
  • Overview of PHSS guidance initiative in Aseptic processing Environmental control and process monitoring 
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    16:05

    Debates and challenges concerning disinfectant validation and methods to circumvent them

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

    • Current debates within the industry surrounding disinfectant coupon testing
    • The importance of disinfectant efficacy testing with particular bacterial spores
    • Technical reports and FDA warning letters in relation to current efficacy testing
    • Current regulatory expectations and how to reduce the cost of testinG

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    16:40

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute

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    9:10

    NEW lessons learned in sterility assurance

    Olivier Chancel

    Olivier Chancel, Sterility and Aseptic Process Assurance Expert , Boehringer Ingelheim

  • Real life experiences observed on the shop floor over the last year to support various activities of the sterility assurance
  • Series of case studies to focus on the practical knowledge, on the "know how" which can be directly applied on daily business by Production, Pharmaceutical Microbiologist and Quality
  • Useful insights on various microbiological aspects to detect sources of contaminations for sterile drug products and to prevent them
  • Forum for open and practical discussions
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    9:45

    Rapid microbial methods – A case study of implementation

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute

    • The implementation of rapid methods in practice, how best to adopt these new methods and keep up with developments
    • Validating the methods and conforming to regulatory requirements
    • The issues surrounding the implementation of rapid methods and how to overcome them
    • How to best tailor your implementation proposal in terms of validation of your rapid method

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    10:20

    Alternative Microbial Methods for Pharmaceutical Water

    Jim Cannon, International Thornton Pharmaceutical Manager, Mettler-Toledo Thornton Inc

  • Pharmacopeia and Regulatory positions on adoption and implementation of alternative microbial technology
  • Guidance for validation and utilization of alternative technology
  • Development and commercialization of alternative microbial technology
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    11:00

    Morning Coffee

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    11:30

    Environmental monitoring – managing excursions and out of trends

    Francesco Boschi, Site Quality Assurance Manager, Pfizer

    • Carrying out an effective investigation on microbiological results: investigation team, investigation tools, evidences collection
    • Planning a feasible corrective/preventive actions (CAPA) plan
    • Follow-up: when is an investigation really completed? How to prevent recurrent deviations.
    • Adverse trend in environmental monitoring: definition and management
    • Out of trend and unusual data

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    12:05

    Operational Impact of the Prominent Microbial Identification Strategies

    Christine Farrance

    Christine Farrance, Director of Research and Development, Charles River Laboratories

  • The inherent strengths and challenges to proteotypic and genotypic microbial identification systems
  • Choosing the appropriate method based on the required resolution of the task at hand
  • Impact of the method and its reference database on decisions made in a regulated environments
  • Performance evaluation of routine identification of organisms of concern to pharmaceutical manufacturing
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    12:45

    Networking Lunch

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    13:45

    Biofilms – what are they and why do they pose such an issue within drug development and delivery?

    Jeremy Webb, Professor of Microbiology, Principal Investigator Biofilms and Microbial Communities, University Of Southampton

    • Background on biofilm infections
    • Case studies – how biofilm infections differ
    • Drug development targets for biofilms and how they are different to antibiotic targets
    • Anti-biofilm drug research so far – what are the advances in this area to date? How can it be taken further?

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    14:20

    Endotoxin testing and microbial risk assessments

    Ingo Spreitzer

    Ingo Spreitzer, Deputy head Section Microbial safety, Paul Ehrlich Institut

  • Pharmacopeia’s current view on Endotoxin / Pyrogen testing
  • The validity of endotoxin testing on its own – quality assurance
  • Should pyrogen testing be done over and above endotoxin testing?
  • Cost / risk: should we do more than requested by regulations?
  • Are the regulations surrounding this topic conclusive?

     

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    14:55

    Afternoon Tea

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    15:25

    Approaches to overcome Low Endotoxin Recovery (LER) using the LAL assay and alternatives to Rabbit Pyrogen Testing

    Ruth Daniels, Senior Scientist, Microbiology Expert, janssen pharmaceutical

    • Limulus Amoebocyte Lysate (LAL) test and Low Endotoxin Recovery (LER)
    • Monocyte Activation Test (MAT) as alternative to Rabbit Pyrogen Testing (RPT)

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    16:00

    Evaluation of the MAT for the safety testing of a meningococcal B vaccine: a collaborative study

    Karin Nordgren

    Karin Nordgren, Head of the Pyrogen Science Group, The National Institute for Biological Standards and Control (

  • Quantifying pyrogenic content of an inherently pyrogenic vaccine using the MAT
  • Collaborative study with 9 participating laboratories, covering a range of cell sources and read-outs
  • Application of Ph. Eur. Chapter 2.6.30 Method C: Reference Lot Comparison Test
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    16:35

    Environmental Monitoring Program (Aseptic Processing) Conventional Clean Rooms / RABS / Isolator

    Benoit Ramond, Senior Microbiology Expert, Sanofi

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    17:10

    Chairman’s Closing Remarks and Close of Day Two

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute


    Research Leader
    Battelle Memorial Institute
    Senior Microbiology Expert
    Sanofi
    Director of Research and Development
    Charles River Laboratories
    Scientific Director
    Biomerieux
    Site Quality Assurance Manager
    Pfizer
    Deputy head Section Microbial safety
    Paul Ehrlich Institut
    Chairman, Head of Aseptic Process Technologies & GMP Compliance
    PHSS, F Zeil GmbH
    Microbiology Lab Manager
    Boehringer Ingelheim
    Professor of Microbiology, Principal Investigator Biofilms and Microbial Communities
    University Of Southampton
    International Thornton Pharmaceutical Manager
    Mettler-Toledo Thornton Inc
    Senior Technical Service Manager
    STERIS Corporation
    Global Product Manager Rapid Detection
    Sartorius Lab Instruments GmbH & Co. KG
    Head of the Pyrogen Science Group
    The National Institute for Biological Standards and Control (
    Sterility and Aseptic Process Assurance Expert
    Boehringer Ingelheim
    Sterility Assurance Lead
    Sanofi
    Professor and Chair of Bacteriology and Hygiene
    University of Veterinary Medicine Vienna
    Product Manager
    Lonza QC Testing Solutions
    Senior Scientist, Microbiology Expert
    janssen pharmaceutical
    CEO
    ImmuneBiotech AB

    Sponsors and Exhibitors

    Official Media Partner

    Official Online Media Partners

    Official Publication

    Supporters

    Workshops

    Objectionable Organisms – What, Why, Who, How?

    Objectionable Organisms – What, Why, Who, How?

    Holiday Inn Kensington Forum
    24 January 2018
    London, United Kingdom

    Rapid Microbial Methods

    Rapid Microbial Methods

    Holiday Inn Kensington Forum
    24 January 2018
    London, United Kingdom

    NEW LESSONS LEARNED IN STERILITY ASSURANCE WITH Boehringer Ingelheim

    Download

    Pharmaceutical Microbiology January 2017 Attendee List

    Download

    The power of flow cytometry with Boehringer Ingelheim

    Download

    Sponsors and Exhibitors


    bioMérieux

    Sponsors and Exhibitors
    http://www.biomerieux.com/en/industry-solutions

    A world leader in the field of in vitro diagnostics for over 50 years, bioMérieux is present in more than 150 countries through 43 subsidiaries and a large network of distributors. In 2017, revenues reached €2.3 billion, with over 90% of sales outside of France. bioMérieux provides diagnostic solutions (systems, reagents, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.


    Charles River

    Sponsors and Exhibitors
    http://www.criver.com/microbialsolutions

    For over 30 years, Charles River has helped customers bring products to market safely and efficiently with revolutionary technologies and exceptional services that have changed the way we conduct microbial quality control. Continuing with a passion to innovate and respond to customers’ needs, our Microbial Solutions group has purposefully expanded its global portfolio to include the leading rapid microbial detection systems of Celsis®. Joining the trusted brands of Endosafe® endotoxin testing and Accugenix® microbial identification, Celsis® creates a powerful trio of micro QC solutions, the most comprehensive offering available from any single provider.


    COPAN

    Sponsors and Exhibitors
    http://www.copangroup.com

    With a rightful reputation for innovation, COPAN is the world leading manufacturer of collection and transport systems. In like manner, COPAN’s collaborative approach to pre-analytics has resulted in the development of FLOQSwabs®, ESwab®, UTM® and modular laboratory automation, WASP® and WASPLab®. For further information on COPAN, visit www.copangroup.com


    Lonza

    Sponsors and Exhibitors
    http://www.lonza.com/

    Lonza is the trusted QC testing solution provider for the pharmaceutical and medical device industries. Lonza transforms its practical knowledge and technical expertise to deliver a portfolio of endotoxin, mycoplasma and microbial detection products, and paperless QC microbiology, software and services that support the critical needs of regulated manufacturing environments.


    NCIMB

    Sponsors and Exhibitors
    http://www.ncimb.com

    NCIMB's skilled microbiologists have extensive experience of providing GMP standard microbial identification and biomaterial storage services to the pharmaceutical sector. We supply a range of QC strains, offer a patent depository service and manage the UK’s National Collection of Industrial Food and Marine Bacteria. This reference collection includes many strains with pharmaceutical sector applications. Our microbial ID service follows auditable procedures using validated equipment and offers same day, next day, three day and ten day turnaround options, with clear reporting that can be tailored to your requirements. NCIMB’s clients include major pharmaceutical companies in the UK and overseas, and we are regularly audited by them, ensuring we meet their quality requirements. Based in Scotland, NCIMB is a well-established provider of microbiology, chemical analysis and biomaterial storage services to industry and academia. We work to high standards to support our customers in their quality control procedures, asset protection, and R&D projects.


    Roche CustomBiotech

    Sponsors and Exhibitors
    http://www.custombiotech.roche.com

    Building on decades of experience as a diagnostics and pharmaceutical manufacturer, Roche CustomBiotech offers a broad range of innovative products and services for in vitro diagnostics, biopharmaceuticals, and cell and gene therapy markets. Some specific product categories include enzymes, high resolution cell counter, robust and reliable photometric-based bioanalyzers, and rapid PCR-based quality control assays for in-process testing and product release. With our extensive industry experience and strong customer orientation, Custom Biotech is committed to helping you achieve success across all stages of the development process.


    Sartorius Lab Instruments

    Sponsors and Exhibitors
    http://www.sartorius.com/sartorius/en/EUR/products/laboratory/microbiology-products/microbiology-overview

    Sartorius Lab Instruments is a one-hundred-percent subsidiary of Sartorius AG. It primarily manufactures laboratory instruments like laboratory balances, lab water systems, pipettes and consumables for research and quality assurance laboratories and provides relevant services. Key customers are from the pharmaceutical, chemical and food industries and from numerous research and educational institutes. The company is headquartered in Goettingen, Germany.

    Media Partners


    Rapid Micro Biosystems

    Official Media Partner
    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.

    Media Partners


    Colorado Bioscience

    Official Online Media Partners
    http://www.cobioscience.com/

    As champions for life science in our state, Colorado BioScience Association leads expansion policies to advance the industry and accelerate growth. We support a thriving bioscience sector by connecting innovators to funding, infrastructure, research and talent. CBSA fosters bioscience workforce and leadership development through opportunities for networking and professional education.

    Media Partners


    International Journal of Computational Microbiology and Medical Ecology

    Official Publication
    http://www.inderscience.com/ijcmme

    IJCMME publishes original research contributions on computational microbiology, microbial bioinformatics, and medical ecology. It also covers all aspects of computational microbial ecology. The journal particularly welcomes contributions from studies in the Human Microbiome Project (HMP) and its ramifications in personalised medicine, and considers human microbiome research as a vitally important field of medical ecology, beyond the scope which the eminent microbiologist René Dubos provided regarding the subject several decades ago.


    International Journal of Ecological Bioscience and Biotechnology

    Official Publication
    http://www.inderscience.com/ijebb

    IJEBB is a peer-reviewed journal offering authors and readers opportunities to share the latest concepts and developments in the increasingly-significant field of ecological bioscience and biotechnology, access current case studies in ecological engineering and explore the market potential for ecological biotechnologies. It covers applications of ecological technology and scientific discoveries to the natural environment, human habitation and environmental sustainability. IJEBB provides a key forum to bring together state-of-the-art research of interest to scientists, engineers and policymakers in related fields worldwide.


    International Journal of Environment and Health

    Official Publication
    http://www.inderscience.com/ijenvh

    IJEnvH is a fully-refereed scientific journal that provides an international forum for the exchange of information and the advancement of knowledge in the multidisciplinary field of environment and health. The aim of IJEnvH is to stimulate the discussion and communication among scientists, researchers and experts with different background and expertise, involved, at different levels, with the study of environment and health problems.

    Media Partners


    Pharmaceutical-Review

    Supporters
    http://www.pharmaceutical-review.com

    Pharmaceutical-review.com is part of Integrated IQ technologies Private Limited(IIQ). A Leading platform for all the Pharma manufacturing companies and buyers across the world.Having a subscriber database of more than 120,000 globally helping the clients to reach their target buyers through our exclusive listing, branding(banner advertisement), e-news letters, e-mail marketing, product reviews, product launch promotions, event marketing, search engine marketing and social media marketing services.


    Biosave

    Supporters
    http://www.Biosave.com

    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    MDPI Biology Journal

    Supporters
    http://www.mdpi.com/journal/biology

    Biology (ISSN 2079-7737, http://www.mdpi.com/journal/biology) is an international, peer-reviewed, quick-refereeing open access journal of Biological Science. This journal is supervised by Editor-in-Chief, Prof. Dr. Chris O'Callaghan and Associate Editor, Prof. Dr. Jukka Finne. Biology is supported by an outstanding Editorial Board which includes a 2002 Nobel Laureate as well as other excellent scientists (http://www.mdpi.com/journal/biology/editors/). Biology is indexed by PubMed, Zoological Record, Scopus, etc (http://www.mdpi.com/journal/biology/indexing).


    Medical Device Network

    Supporters
    http://www.medicaldevice-network.com/

    Medicaldevice-network.com is your one stop for information on the medical device industry, covering everything along the supply chain from biomaterials and materials solutions to electronics, packaging, motors and motion control, outsourcing and more. Through our international team of journalists, we cover diagnosis, prevention, monitoring, standards, treatment and technology – all you need as a professional in the medical industry to stay abreast of the latest developments in your field.


    GBI

    Supporters
    http://www.gbihealth.com/

    GBI is an information, applications, and services company focused on the healthcare industry. Leveraging data from across the healthcare value chain, GBI creates web and mobile applications that enable individuals and organizations to make better decisions and communicate more effectively.


    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.


    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    Mednous

    Supporters
    http://www.MedNous.com

    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


    Pharmaceutical Technology

    Supporters
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    Absave

    Supporters
    http://www.absave.com

    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Inderscience Publishers

    Supporters
    http://www.inderscience.com

    Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.


    EIN Presswire

    Supporters
    http://www.einpresswire.com/free

    EIN Presswire has a distribution "foot-print" that includes millions of users of our EIN Newsdesk media monitoring services. We also maintain one of the world's leading media directories providing us with up-to-date contacts for media in every country and U.S. state. Further distribution is achieved via RSS, email, partner websites, and social media. We are both a destination (EIN Newsdesk) and a distributor (EIN Presswire) for news. In one place you can distribute your news to the targeted audiences you select and monitor news on that topic published by thousands of worldwide sources. For more information or to try us FREE, please visit www.einpresswire.com/free


    Pharmavision

    Supporters
    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.


    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!


    Labsave

    Supporters
    http://www.labsave.com

    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/


    One Nucleus

    Supporters
    http://www.onenucleus.com

    Established in May 2010, One Nucleus is the result of the merger of ERBI and London Biotechnology Network. One Nucleus is a not-for-profit membership organisation for international life science and healthcare companies and the largest of its kind in Europe. The company is based in Cambridge UK and London, at the heart of Europe's largest cluster. The 470 members include pharmaceutical, biotech, medical device and diagnostic companies and associated technical and commercial Service Providers.


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

    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.


    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.


    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


    SelectScience

    Supporters
    http://www.selectscience.net/register?utm_source=Media-Partner&utm_medium=Website&utm_campaign=SMI

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover the latest drug discovery and development technologies, products and techniques with product reviews, videos, application notes and news articles. Become a member for free today.


    Pharmacircle

    Supporters
    http://www.pharmacircle.com

    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….


    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.


    European Biotechnology Network

    Supporters
    http://european-biotechnology.net/

    The European Biotechnology Network is dedicated to facilitating co-operation between professionals in biotechnology and the life sciences all over Europe. The non-profit organisation brings research groups, universities, SMEs, large companies and indeed all actors in biotechnology together to build and deliver partnerships.


    Biocompare

    Supporters
    http://www.biocompare.com

    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.


    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.


    Technology Networks

    Supporters
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Drug Development Technology

    Supporters
    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.

    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

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    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    HOTEL BOOKING FORM

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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
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