Home
overview

SMi’s 9th Annual Conference
Pharmaceutical Microbiology UK
January 20 - 21, 2020 | London, United Kingdom
-------------------------------------------------------------------------

Pharmaceutical Microbiology as an industry is projected to see significant advancements in the next five years. This forecast is largely attributed to rapid microbiology testing, which has accounted for $3.5 billion last year, while projected to reach nearly double at $6 billion by 2025, and an estimated CAGR of 8.3% leading up to 2025.


At the very core of pharmaceutical microbiology is the accurate and reliable detection of microorganisms that would otherwise contaminate the pharmaceutical products manufactured. This demand for more rapid methods for detection and identification will be accompanied by equally important areas such as: contamination control strategies and environmental monitoring, process automation, and discussing updates to meet regulatory requirements.
 

Join us this year to explore novel and developing technologies that tackle the most pressing challenges and push innovation in world of pharmaceutical microbiology.
 

Allergan Biologics Ltd; Allergy Therapeutics; Allergy Therapeutics UK; AllergyTherapeutics; AstraZeneca; Atalmedial; Baxter Healthcare Ltd; Biomerieux; bioMerieux UK Limited; Boehringer Ingelheim; BPL; British America Tobacco; Cancer Research UK; Cell and Gene Therapy Catapult; Ceutiqus; CGT - Catapult ; CGT (Cell & Gene Therapy Catapult) ; ChargePoint Technology; Charles River; Copan Italia SpA; Dupont De Nemours (Luxembourg) S A; DuPont de Nemours Luxembourg sarl; Fresenius Kabi; Fresenius Kabi UK Ltd; Fujifilm Wako Chemicals USA Corp; Genzyme Geel; Greiner Bio-One; GSK; GSK Vaccines; International Serum Industry Association; Ipsen; Kings College London; MeiraGTx; Mettler Toledo; Mettler Toledo Ltd; Mettler-Toledo Ltd; Mettler-Toledo Thornton; MHRA; Microrite, Inc.; Novo Nordisk; Oak Zone Biotech; Pharmaceutical and Healthcare Sciences Society; Roche Diagnostics Deutschland GmbH; Royal Free Hospital; RSSL; Sanofi; Sanofi Pasteur; Steris Corporation; Synthon Chile; TEVA Runcorn; Teva UK Ltd; The LFB Group; University of Southampton; University of Veterinary Medicine Vienna; zac vventures inc;

FEATURED SPEAKERS

James Drinkwater

James Drinkwater

Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS

David Elder

Constultant, David P Elder Consultancy
David Elder

Dr. Elder has 42 years of service within the pharmaceutical industry, with Sterling, Syntex and 23 years with GSK. He is now an independent CMC consultant and has broad based experience in formulation, microbiology and analytical method development.
Dr. Elder obtained his PhD in crystallography from the University of Edinburgh. Dr. Elder is a visiting professor at King’s College, London. He is a Fellow of the RSC and chartered chemist and scientist. He is a member of the British Pharmacopoeia. He is the chairman of JPAG (Joint Pharmaceutical Analysis Group). He is a member of the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. He has published 18 book chapters, 147 papers in international journals and has given 19 webinars and over 167 presentations at national/international symposia. He has 9 patents to his name.
He has co-edited a book on the Analytical Characterisation and Separation of Oligonucleotides and their Impurities (with George Okafo and Mike Webb) and a second on the ICH Quality Guidelines (with Andy Teasdale and Ray Nims).
 

Gabriele Savoldi

Business Development Manager, Copan Group
Gabriele Savoldi

Ian Symonds

Head, Aseptic Intelligence and Strategy, GSK
Ian Symonds

Recently established SDA Pharma Limited with co-managing Director Mike Davies. With almost 80 years’ experience in the industry SDA can provide a wide range of services form facility design and Qualification support to bespoke training and regulatory compliance advice.

My role in GSKs Global Quality was responsible for setting and monitoring Quality standards for the Global Manufacture and Supply division for pharmaceutical sterile manufacturing operations worldwide. Following the merger of GlaxoWellcome and SmithKlineBeecham in 2000 I established a team of subject matter experts to establish a common set of compliance standards for the new GSKs Quality Management System. I continued to lead that team right up to my retirement in 2018.
 

Ian Symonds

Director, Pharmaceutical Consultant, SDA Pharma
Ian Symonds

Ingo Spreitzer

Deputy head Section Microbial safety, 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 Cannon

Head of OEM and Markets, Mettler-Toledo Thornton
James Cannon

James Drinkwater

Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS
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.
 

Jason McGuire

Vice President, Global Quality, Steriile Services to end
Jason  McGuire

Jason has spent nearly 20 years in the health care industry serving in many roles with a particular focus on Quality control operations, Quality assurance and regulatory support. He’s a microbiologist by education and expertise, spending 2 years on the bench developing anaerobic microbial catalysts for fuel ethanol production. For the last 15 years, he has worked with non-sterile and sterile compounding facilities, national health systems, medical device, biotechnology and pharmaceutical companies helping them troubleshoot and bringing resolution to complex challenges.

Jim Polarine

Technical Service Manager, Steris Corp
Jim Polarine

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for eighteen 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 and microbial control 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. Mr. Polarine teaches the cleaning and disinfection course at the PDA Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is currently President Elect for the PDA Missouri Valley 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.

Luis Meirinhos-Soares

Inspector, Infarmed - Instituto Naciuonal Da Farmacia E Do Medicamento
Luis Meirinhos-Soares

Head of the Microbiology Lab at INFARMED, the Portuguese Medicines Agency (PORTUGAL) for 16 years;
B.Sc. (Hons.) in, Biochemistry, and M.Sc. Biotechnology;
Expert of the European Pharmacopeia Working Groups (Microbiology, Blood Products, Biotechnology), Member of the Portuguese Pharmacopeia Commission, Auditor of the European OMCL Network (Microbiology and Biotechnology). Consultant for WHO Prequalification Program on Medicines, UNDP and UNICEF;
Invited Lecturer at the M.Sc. Quality Control (Univ. Porto), and at the B.Sc. in Biochemical Engineering (Univ. Lisbon)
Since January 2019 he joined the Pharmaceutical Inspectorate
 

Maria Jose Zafra-Domene

QC Microbiologist, MeiraGTx
Maria Jose Zafra-Domene

Originally from Spain, Maria relocated to the UK after completing her MSc in Biotechnology at the University of Granada. Maria began working as a QC Microbiology Technician in environmental monitoring at Nice Pak International in Flint (Wales), a wet wipes non-cleanroom manufacturing site. From here, Maria established her cleanroom environmental monitoring knowledge at Fresenius Kabi in Runcorn (England). After 6 years, she took on the position of QC Microbiologist in MeiraGTx, a gene therapy start-up based in London. Drawing from her experience, Maria has developed the environmental monitoring programme of a brand-new cleanroom facility within MeiraGTx. Now, she leads a team of QC Microbiology Technicians.

Michael Song

Sr. Manager, AstraZeneca
Michael Song

Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Olivier Chancel

Sterility Assurance Expert, Boehringer Ingelheim
Olivier Chancel

Doctor Pharmacist, graduated in technological pharmacy, quality control and management. Currently Sterility and Aseptic Practice Assurance Expert and formerly Head of Performance and Pharmaceutical Support in Boehringer Ingelheim, Toulouse, France. Provide a corporate support on sterility and aseptic processes to Boehringer Ingelheim Animal Health sites. Used to work in or with the pharmaceutical industry for 15 years at various positions including pharmaceutical research and development, Quality Assurance, Quality Control, project management and production for both solid and injectable dosage forms.

Pratixa Patel

Microbiological Sciences Director, Glaxo Smith Kline
Pratixa Patel

I am working as a Microbiology & Stability Science Senior Director at GlaxoSmithKline Consumer Health, with 15 years of experience working in various roles in Microbiology, Analytical and Quality Assurance.
 
I have previously worked at P&G and Dr Reddys Laboratories. At Dr Reddys I held a position of Head of Microbiology for sterile, non-sterile and API manufacturing operations. I was responsible for setting the strategy to develop Microbiology systems and controls throughout the global supply chain and provided leadership to the micro function. Prior to that, I have worked at Procter & Gamble for 12 years including EMEA Regional Microbiology Head and Global head for Quality Analytical. I have held various assignments across R&D, Manufacturing and Commercial functions. My expertise is deeply rooted in Microbiology QbD, manufacturing controls, risk mitigation plans as well as organisational development of technical functions.
 
I hold a BSc degree in Microbiology and Virology (University of Warwick, UK) and a PhD in Biofilm research from the University of Birmingham, UK.
 

Sonia Allibardi

Market Access Manager, Copan Group
Sonia  Allibardi

Molecular biologist with a specialization degree in Biochemistry Science. Currently working in the Scientific Team of COPAN as Market Access Manager for the implementation of innovative Medical Devices in pre-analytics focusing on Italy, Eastern Europe and Asia Pacific Market. Her professional life started in a research Cardiovascular Physiology laboratory at San Raffaele Scientific Institute, Milan Italy, where She worked for more than 10 years and published scientific papers on International Journals. The objective of her research was the evaluation of myocardial metabolism in hypoxic and ischemic heart. In 2011, thanks to the “Mad Cow Disease”, She started a new job in Biorad Company. She spent three years as scientific product specialist in the life science division for Italy and Southern Europe (Spain, Greece, Portugal). She moved to Cepheid Europe for five years where her main topics were: Women’s Health, Hospital Acquired Infection and Tuberculosis.

Sophie Drinkwater

QC Technical Officer, AstraZeneca
Sophie Drinkwater

Sylvanie Cassard Guilloux

Global solution Manager, BioMérieux
Sylvanie Cassard Guilloux

Sylvanie has a strong scientific background (PhD at Paris VII University; post-doctoral experience at Rockefeller University) in cellular and molecular biology. On her return to France, Sylvanie joined industry, and had 13 years of experience as technical leader or in R&D in several laboratories, developing and using molecular methods for industry quality controls, while she also participated to standardization of these methods as a group leader at the french normalization body (AFNOR). In 2012, after a Master of Business at Audencia business school, she joined the global marketing department of bioMérieux, where she is defining and guiding the development of new solutions for pharmaceutical microbiological controls.

Tim Eaton

Sterile Manufacturing Specialist, AstraZeneca
Tim Eaton

Tim Eaton B.Sc. (chemistry) has over 25 years’ experience of steriles manufacture with Zeneca Pharmaceuticals and AstraZeneca. During this time he has had extensive roles in technical support, production management and specialist activities for aseptically prepared products. He has had responsibilities for the design, construction, start up and validation of multimillion pound aseptic manufacturing facilities and has managed the introduction, technical transfer and scale up activities for a number of sterile products. He has published a number of papers relating to cleanroom activities and has also presented at various industry forums in Europe, Asia and the US.
In his current role of Sterile Manufacturing Specialist he has responsibilities for the derivation, optimisation and implementation of best practices for aseptically prepared products. He sits on LBI/30, the British Committee for Cleanroom Technology.
 

Veronika Wills

Manager, Technical Services, Associates of Cape Cod
Veronika Wills

Sponsors

Exhibitors

Workshops

How to Develop a Risk Based Approach to Cleaning and Disinfection
Workshop

How to Develop a Risk Based Approach to Cleaning and Disinfection

Copthorne Tara Hotel
22nd January 2020
London, United Kingdom

Designing an Environmental Monitoring Programme
Workshop

Designing an Environmental Monitoring Programme

Copthorne Tara Hotel
22nd January 2020
London, United Kingdom

Rapid Micro Methods, Endotoxin Testing and LER
Workshop

Rapid Micro Methods, Endotoxin Testing and LER

Copthorne Tara Hotel
22nd January 2020
London, United Kingdom

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

Sponsors


Associates of Cape Cod

Sponsors
http://www.acciusa.com/acc/index.html

Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin and (1?3)-ß-D-glucans detection products and services for nearly 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents.


bioMérieux

Sponsors
http://www.thepeoplebehindthescience.com

bioMérieux provides a wide range of solutions for microbiological control dedicated to the pharmaceutical industry. bioMérieux provides solutions for in-process controls and final product testing. From surface and personnel monitoring to air sampling, microbial detection and identification, bioMérieux helps the pharmaceutical industries manage microbiological risks and achieve compliance.


COPAN

Sponsors
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


METTLER TOLEDO

Sponsors
http://www.mt.com

METTLER TOLEDO Thornton has a long history of delivering real time, continuous measurement products specifically designed for regulated pharmaceutical water systems such as Conductivity, TOC, and Ozone. The 7000RMS Real time Microbial System instantly detects and counts microbial (bioburden) presence enabling increased sensitivity, better process control, improved product quality, and reduced risk.

Exhibitors


RSSL

Exhibitors
http://www.rssl.com

RSSL provides analytical, investigational, consultancy and training services to clients in the global pharmaceutical, biopharmaceutical and healthcare industries. Our GMP compliant facilities are located in the UK and with our team of more than 300 dedicated employees, we ensure that every project is performed with our commitment to outstanding quality, scientific excellence and customer satisfaction. We offer a large portfolio of, chemical, physical, biochemical and microbiological services providing support through the full drug product life cycle.


Veltek Associates Inc

Exhibitors
www.sterile.com

Veltek Associates, Inc. (VAI) is an EPA/FDA registered manufacturing facility, specialising in contamination control. Our range of sterile disinfectants, sporicides, wipes and process cleaning detergents, complement our sterile, disposable cleanroom garments which offer comfortable, breathable garments with outstanding particulate performance. Along with our environmental air sampling equipment to determine levels of contamination present in the air, Veltek is committed to providing our customers with the highest quality products.

SAVE TO


Outlook Calendar  OUTLOOK CALENDAR
Google Calendar  GOOGLE CALENDAR
ICal Calendar  ICAL CALENDAR
Yahoo! Calendar  YAHOO! CALENDAR

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.

 

HOTEL BOOKING FORM

Title

SubTitle
speaker image

Content


Title


Description

Download


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

Event Title

Headline

Text
Read More

I would like to speak at an event

I would like to attend an event

I would like to sponsor/exhibit at an event

SIGN UP OR LOGIN

Sign up
Forgotten Password?

Contact SMi GROUP LTD

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
Registered in England No: 3779287 VAT No: GB 976 2951 71




Forgotten Password

Please enter the email address you registered with. We will email you a new password.

Thank you for visiting our event

If you would like to receive further information about our events, please fill out the information below.

By ticking above you are consenting to receive information by email from SMi.
Full details of our privacy policy can be found here https://www.smi-online.co.uk/privacy-legals/privacy-policy/.
Should you wish to update your contact preferences at any time you can contact us at data@smi-online.co.uk.
Should you wish to be removed from any future mailing lists please click on the following link http://www.smi-online.co.uk/opt-out