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SMi 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.
 

Stay up to date with the latest developments in this field.

Learn how Brexit will affect you.

Discover how you can maintain utmost efficiency during production and testing.

Testimonials from previous delegates:
“A very enjoyable and informative conference, in a good venue.”
“Great conference – some valuable learning and networking. Thank you!”
“Very interesting, I got answers to some issues addressed to me. Thanks!”
 

Senior Microbiologist, Lead Scientist, Laboratory Manager, QA Specialist Drug Substance External Manufacturer, Business Development Manager – Testing, Pharmaceutical Microbiology Consultant, Higher Pharmacopoeial Scientist, Analytical Standards Specialist

Alexion; Alexion Pharmaceutical, Inc.; Allergan Biologics Ltd; AllergyTherapeutics; Astrazeneca; Battelle Memorial Institute; Bettelle Pacific N W Lab; Biomerieux; bioMérieux SA; Biovian Ltd; Bristol Myers Squibb; Confarma France S A R L; David P Elder Consultancy; GE Healthcare; GSK; Ith Pharma; Lonza Biologics plc; Lonza Cologne GmbH; Lonza Incorporated; Merck; Merial; Merial Animal Health; Merial Sas; Mettler-Toledo Ltd; Mettler-Toledo Thornton; MHRA; MIcrobiologics; Nottingham Trent University; Param Enterprises; Paul Ehrlich Institut; Pfizer; Pfizer Inc; PMT (GB) Ltd; PrEP Biopharm; Public Health England; Reading Scientific Services Limited; Regeneron Ireland UC; Regeneron Pharmaceuticals Inc.; Roche; Roche Diagnostics Deutschland GmbH; Samedan Ltd ; Sanofi; Sanofi Pharma; seqirus; Shire Laboratories; Steris; STERIS Corporation; The Cell and Gene Therapy Catapult; TSI;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Olivier Chancel

Olivier Chancel, Sterility and Aseptic Process Assurance Expert , Merial Sas

9:10 How the development of Mycoplasma testing could potentially revolutionise quality control

Renate Rosengarten

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

9:50 The regulatory red tape around Mycoplasma testing and why is it in place

10:30 Morning Coffee

11:00 Creating a Culture of Data Integrity

Felix Montero-Julian

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

11:40 Microbiome therapies & the regulatory issues surrounding the development of this field

Shahram Lavasani

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

12:20 SESSION RESERVED FOR LONZA

13:00 Networking Lunch

14:10 Panel Discussion: Brexit – How the UK leaving the EU will affect manufacturing and the industry as a whole

Shahram Lavasani

Shahram Lavasani, CEO, ImmuneBiotech AB

• Main consequences of the withdrawal
• Key principles and working methodology
• Ensuring minimal disruption and encouraging business continuity
• The legal timeline and projection of process implementation

FURTHER SPEAKERS TO BE CONFIRMED

14:50 Fungal and bacterial spores and spore contamination control

Patrick Nieuwenhuizen

Patrick Nieuwenhuizen, Manager Quality Control, Genzyme Ireland Ltd

• 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

15:30 Afternoon Tea

16:00 Bio-Contamination Control - Is it time to change our approach?

Ian Symonds

Ian Symonds, Head, Aseptic Intelligence and Strategy, GSK

• This presentation will review and challenge the current approach to environmental monitoring which has been long held as the “standard approach”
• The expected approach from regulatory authorities
• In today’s world with advanced technologies, isolators, robotics etc., should we consider a different approach to Environmental Monitoring?
 

16:40 Flow cytometry technology and its applications

Jean Reyes

Jean Reyes, Microbiology Lab Manager, Merial Sas

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

17:20 Chairman’s Closing Remarks and Close of Day One

Olivier Chancel

Olivier Chancel, Sterility and Aseptic Process Assurance Expert , Merial Sas

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Andrew Bartko

Andrew Bartko, Research Leader, Battelle Memorial Institute

9:10 General Sterility and Aseptic Technique

Olivier Chancel

Olivier Chancel, Sterility and Aseptic Process Assurance Expert , Merial Sas

• The most efficient methods to assure sterility within clean rooms
• Cost effective practices of aseptic technique
• Case studies of successful aseptic/ sterility practices which can be used in the laboratory
• The latest developments and trends within this practice

9:50 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

10:30 Morning Coffee

11:00 SESSION RESERVED FOR CHARLES RIVER LABORATORIES

11:40 Environmental Monitoring – sampling plan justification

Benoit Ramond

Benoit Ramond, Senior Microbiology Expert, Sanofi

• Process manufacturing and the justification of monitoring programmes
• Monitoring in terms of incubation environments
• Specific particle monitoring methods to detect viable and non-viable particles
• The when, the where and the how of environmental monitoring – the best ways to carry these methods out

12:20 Networking Lunch

13:30 Environmental monitoring – managing excursions and out of trends

Francesco  Boschi

Francesco Boschi, Site Quality Assurance Manager, Doppel Farmaceutici

• 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

14:10 Debates and challenges concerning disinfectant validation and methods to circumvent them

Jim Polarine

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

14:50 Biofilms – what are they and why do they pose such an issue within drug development and delivery?

Jeremy Webb

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?

15:30 Afternoon Tea

16:00 Approaches to overcome Low Endotoxin Recovery (LER) using the LAL assay and alternatives to Rabbit Pyrogen Testing

Ruth Daniels

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)

16:40 Chairman’s Closing Remarks and Close of Day Two

Andrew Bartko

Andrew Bartko, Research Leader, Battelle Memorial Institute

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Sponsors and Exhibitors

Workshops

Objectionable Organisms – What, Why, Who, How?
Workshop

Objectionable Organisms – What, Why, Who, How?

Holiday Inn Kensington Forum
24th January 2018
London, United Kingdom

VENUE

Holiday Inn Kensington Forum

97 Cromwell Road , London, United Kingdom

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. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

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

Sponsors and Exhibitors


bioMérieux

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

A world leader in the field of in vitro diagnostics for more than 50 years, bioMérieux is present in more than 150 countries through 42 subsidiaries and a large network of distributors. In 2016, revenues reached €2,103 million, with more than 90% of international sales. bioMérieux provides diagnostic solutions (reagents, instruments, 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.


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.

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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. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

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

GLOBAL CPD

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

CPD Certificates

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

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