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SMi’s 10th Annual Conference
Pharmaceutical Microbiology UK
January 18 - 19, 2021 | 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 addressed alongside equally important areas such as: contamination control strategies and environmental monitoring, process automation, and discussing effective strategies to meet updated regulatory requirements.

Join us at SMi’s 10th Annual Pharmaceutical Microbiology Conference to explore the newest case studies and latest technologies that tackle the most pressing challenges and are pushing innovation in world of pharmaceutical microbiology.

INSIGHT into the complex regulatory landscape and extensive regulator expectations
EXPLORE the latest advancements in environmental monitoring technology and strategy
DELVE into contemporary case studies delivered by experts in agile contamination control
ATTAIN expert tuition in environmental monitoring and aseptic-containment strategies for
hazardous products at the post-conference workshops
DISCUSS robust strategies in global pharmaceutical distribution during the COVID-19 pandemic
 

• Heads of Aseptic Processing
• Heads of Microbiology
• Global Quality Directors
• Heads of GMP Compliance
• Quality & Compliance Heads
• Microbiology Senior Specialists
• Heads of Site Compliance
• Heads of Sterile Technology
• Global Microbiology Analytical Experts
• Directors of Quality Control Biology

• Previous attendees include:

Allergy Therapeutics Ltd; AllergyTherapeutics; Associates of Cape Cod; Associates Of Cape Cod International; AstraZeneca; AstraZeneca PLC; Baxter; Baxter Healthcare Ltd; BioMerieux; bioMerieux UK Limited; BioPhorum; Boehringer Ingelheim; Boehringer Ingelheim Pharma GmbH & Co. KG; Charles River EMD; Christian Doppler Laboratory for Monitoring of Contaminants, University of Veterinary Medicine, Vienna; Copan; Copan Group; Copan Italia SpA; CTL - Mat; David P Elder Consultancy; European Patent Office; Fagron; Freeline; Fresenius Kabi; Fresenius Kabi UK Ltd; GSK; GSK Vaccines; GW Pharma ; King's College London ; Kite Pharma ; Lonza; MeiraGTx; Meriagtx; Mettler Toledo; Mettler Toledo Ltd; Mettler-Toledo Ltd; Mettler-Toledo Thornton; MHRA; MIcrobiologics; Microgenetics Ltd; Novo Nordisk; Oxford Biomedica Ltd; Paul Ehrlich Institut; PHSS: Pharmaceutical & Healthcare Sciences Society; Reading Scientific Services Ltd; Reading Scientific Services Ltd (RSSL); Regeneron Pharmaceuticals Inc.; RSSL; Sanofi-Aventis Deutschland GmbH; SDA Pharma; Steris Corporation; Techniconsult Firenze SRL; University of Veterinary Medicine Vienna; VCCN/Brookhuis Applied Data Intelligence; Veltek Associates, Inc.;

Conference programme

8:00 Registration & Coffee

9:00 Chairman's Opening Remarks

James Drinkwater

James Drinkwater, PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

9:10 Microbial monitoring of pharmaceutical grade water systems

Di Morris

Di Morris, Senior Manager, Team Leader, GSK
View Bio

• Water requirements from Ph. Eur. and Annex 1
• Microbial contamination of water systems
• Impact on facilities and products
 

9:50 Innovative Environmental Monitoring (EM) processing

Juliana Nassette

Juliana Nassette, Team Lead QC Microbiology, Kite Pharma
View Bio

• Literature study performed to set conditions for experimental conditions.
• Explore a meaningful approach to EM processing taking into account:
       o Suitable incubation temperatures
       o Minimum incubation time
       o Adequate medium for detection of both bacteria and molds
• Discussion on how this innovative approach has enhanced quality of results

 

10:30 Morning Coffee

11:00 Phase III – Performance qualification of the disinfection regime

Helen Gates

Helen Gates, Global Technical Consultant, Ecolab
View Bio

• A review of the final phase of implementation of a cleaning and disinfection regime; the performance qualification phase, also referred to as Phase III or in-situ field studies
• The purpose of this phase is to demonstrate the effectiveness of a cleaning and disinfection regime once it is in use within the facility, through the generation of data
• The presentation will outline possible structures to a Phase III program, how to handle the data generated and how to capitalise on the study to address other elements of a cleaning and disinfection regime, such as residue management and surface deterioration.
 

11:40 New paradigm for Environmental Monitoring Programs - How to justify the practices in routine

Benoît Ramond

Benoît Ramond, Head of Microbiology & Sterile Technology, Sanofi
View Bio

• Viable and Non-viable Environmental Monitoring
• What is new in the Regulations?
• EM program and Contamination Control Strategy
• Example of Risk Analysis Methodology
• EM program and Data Management
 

12:20 Networking Lunch

13:20 Contamination Control, Qualification and Classification of Barrier Technology for Aseptic process filling

James Drinkwater

James Drinkwater, PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

• Case study: Contamination Control Strategy (CCS) applied to Barrier Technology Filling line
• Aseptic – Containment for cross contamination control and/or filling hazardous products
• Approach to Classification and Qualification of an Aseptic processing Filling line
• Key points to consider in Annex 1 and FDA guidance on Aseptic processing compliance
 

14:00 Contamination Control Strategy – an essential part of EU GMP Annex 1

Henrietta Vinneras

Henrietta Vinneras, Senior Manager, Microbiology & Aseptic Technique, Fresenius Kabi
View Bio

• Which elements should be included into the contamination control strategy (CCS)?
• What does a CCS look like? (real-life example from industry)
• What is the benefit of a CCS?
• How will we know if the strategy is functioning as intended?
 

14:40 Afternoon Tea

15:10 Prevention of the biological risks in an R&D and QC laboratory

Philippe  Dhoms

Philippe Dhoms, Head of Bioprocess Development and Industrialisation, Boehringer-Ingelheim

• Insight into biosafety and biosecurity coordination of R&D facilities
• Identifying acceptable and unacceptable biorisks in laboratory assessment
• Biocontainment of pathogenic microorganisms in the lab
• Biosafety considerations in quality control and bioprocessing
 

*Remote presentation

15:50 Minimizing the disruption of the pharmaceutical supply chain during the COVID-19 pandemic

Tony Cundell

Tony Cundell, Principal Consultant, Microbiological Consulting, LLC
View Bio

• Risk Assessment on the impact of the COVID-19 pandemic on the pharmaceutical supply chain
• SARS-CoV-2 attributes, viral transmission, persistence in the air and on inanimate surfaces, and inability of mammalian cell cultures to support the growth of the virus
• Risk mitigations - screening of employees, working from home, cleaning and disinfection of manufacturing facilities, social distancing in the workplace, use of GMP-mandated personal protective equipment to counter the spread of the disease, and the role of HVAC systems in viral clearance
• Future role of virus and antibody screening and COVID-19 vaccination
 

*Remote presentation

16:30 Chairman’s Closing Remarks and Close of Day One

James Drinkwater

James Drinkwater, PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Jim Polarine Jr

Jim Polarine Jr, Senior Global Technical Service Manager, Steris Corporation
View Bio

9:10 Automating Endotoxin water monitoring at Boehringer Ingelheim with Endosafe® Nexus™ – A business and validation perspective

Johannes Oberdoerfer

Johannes Oberdoerfer, Lead Scientist, Rapid Microbiology Methods, Boehringer Ingelheim Pharma GmbH & Co. KG
View Bio

• Build your business case to show the impact of automation in your lab
        o Why is an economic assessment necessary?
        o Definition of financial parameters for your business case
        o Case study: business case of water monitoring with Endosafe® Nexus™ at BI
• Define your validation strategy
        o Match the technology to the right application: water monitoring
        o Validation approach for automated compendial methods
        o Case study: validation of water monitoring with Endosafe® Nexus™ at BI
• The Endosafe® Nexus™ in routine 
        o The importance of monitoring your automated rapid microbiological method
        o A look at the operating performance of Endosafe® Nexus™ units installed at BI
        o Benefits and opportunities of Endosafe® Nexus™ from BI perspective

*Remote presentation
 

9:50 Rethinking QC Microbiology in the Age of Advanced Manufacturing Technologies

Joseph McCall

Joseph McCall, Associate Director, QA Technical Service , ADMA Biologics
View Bio

• Suitability of cultivation-based microbiology in modern cleanroom manufacturing
• Appraising the appraisal – Examining current strategies for assessment of sterilization, disinfection, environmental monitoring, isolator technology, post-approval changes, and more.
• Paths Forward – Discussion on collaborative efforts within industry and regulatory bodies.
 

10:30 Morning Coffee

11:00 A risk-based cleaning and disinfection program

Jim Polarine Jr

Jim Polarine Jr, Senior Global Technical Service Manager, Steris Corporation
View Bio

• Bringing clarity to the cleaning and disinfection process by covering current industry trends, global regulatory expectations, and essential elements needed to keep the cleanroom in a state of control
• In-depth discussion on current regulations, disinfectant and sterilant technologies, operator safety, and applications of these products
• Understanding current industry trends regarding cleaning and disinfection best practices and how to design an effective risk-based program. Current industry FDA Warning Letters and FDA 483s will be covered as teaching tools
• Assessing regulatory expectations of FDA, MHRA, ANVISA, ANMAT, HPRA, EMA, and ANSM inspectors and the current draft Annex I, USP 43 <1072>, and PDA Technical Report #70
 

11:40 Refrigerated pharmaceutical products Supply Chain Management & Distribution in time of pandemic

Francesca  Burberi

Francesca Burberi, CCI Projects Sr. Consultant, Eli Lilly Italia SpA

• Lessons learned during COVID-19 Crisis on refrigerated pharmaceutical products distribution
• How a risk management approach can help in the pharmaceutical supply chain
• Refrigerated products distribution and Business Continuity Management in a pandemic
• The importance of digital distribution practices to face potential new emergencies
 

*Bullet points subject to final confirmation

**Remote presentation

12:20 Networking Lunch

13:20 Cleaning Validation Maintenance Program

Fred Ohsiek

Fred Ohsiek, Senior Specialist, Cleaning Validation, Novo Nordisk
View Bio

• Avoiding industry routine monitoring program pitfalls
• In-depth discussion on periodic review, CPV, and dated validation packages
• Process control risk assessment scope and purpose
• Case studies in the best practice in CPV risk assessment
 

14:00 Challenges associated with interpreting Aberrant/OOT results obtained from Rapid Microbiology method for detection of Mycoplasma using real-time Polymerase Chain Reaction for release of cell therapy products

Cheryl Dennis

Cheryl Dennis, Principal Quality Control Scientist CAR T, Bristol Myers Squibb

• Investigational focus
• Investigational testing
• Interpreting results
• Determining root cause and identifying corrective and preventative actions
 

14:40 Afternoon Tea

15:10 Data integrity in the microbiology lab

Ian Ramsay

Ian Ramsay, Independent Quality Consultant, RamsayPharma
View Bio

• Key data integrity risks
• Areas of regulatory focus
• Simple controls & remediation

15:50 Chairman’s Closing Remarks and Close of Day Two

Jim Polarine Jr

Jim Polarine Jr, Senior Global Technical Service Manager, Steris Corporation
View Bio

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FEATURED SPEAKERS

Benoît Ramond

Benoît Ramond

Head of Microbiology & Sterile Technology, Sanofi
Cheryl Dennis

Cheryl Dennis

Principal Quality Control Scientist CAR T, Bristol Myers Squibb
Di Morris

Di Morris

Senior Manager, Team Leader, GSK
Fred Ohsiek

Fred Ohsiek

Senior Specialist, Cleaning Validation, Novo Nordisk
Helen Gates

Helen Gates

Global Technical Consultant, Ecolab
Henrietta Vinneras

Henrietta Vinneras

Senior Manager, Microbiology & Aseptic Technique, Fresenius Kabi
Ian Ramsay

Ian Ramsay

Independent Quality Consultant, RamsayPharma
James Drinkwater

James Drinkwater

PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
Jim Polarine Jr

Jim Polarine Jr

Senior Global Technical Service Manager, Steris Corporation
Johannes Oberdoerfer

Johannes Oberdoerfer

Lead Scientist, Rapid Microbiology Methods, Boehringer Ingelheim Pharma GmbH & Co. KG
Joseph McCall

Joseph McCall

Associate Director, QA Technical Service , ADMA Biologics
Juliana Nassette

Juliana Nassette

Team Lead QC Microbiology, Kite Pharma
Philippe  Dhoms

Philippe Dhoms

Head of Bioprocess Development and Industrialisation, Boehringer-Ingelheim

Benoît Ramond

Head of Microbiology & Sterile Technology, Sanofi
Benoît Ramond

Ramond  Benoît is a Doctor in Pharmacy at the University of Paris XI in France and holds a PhD in Microbiology.
He has more than 30 years of experience in the Pharmaceutical Industry.
Since 2016 he has been Head of Microbiology and Sterile Technology Expertise in the Sanofi Group. In his function he has also a leading role in the Annex 1 implementation program within Sanofi.
 

Cheryl Dennis

Principal Quality Control Scientist CAR T, Bristol Myers Squibb
Cheryl Dennis

Di Morris

Senior Manager, Team Leader, GSK
Di Morris

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

Francesca Burberi

CCI Projects Sr. Consultant, Eli Lilly Italia SpA
Francesca  Burberi

Fred Ohsiek

Senior Specialist, Cleaning Validation, Novo Nordisk
Fred Ohsiek

Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk. He was considered the cleaning validation subject matter expert in most positions held.
His cleaning validation experience includes developing, validating, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved API and finish product manufacturing start-up, remediation, legacy process justification, and increasing manufacturing capability. He has authored documents and executed in every aspect of the cleaning validation process.
 

Helen Gates

Global Technical Consultant, Ecolab
Helen Gates

Helen Gates is a Microbiologist with more than fifteen years’ experience within the Pharmaceutical Industry, holding roles within Microbiology, Quality and Production, supporting the manufacture of sterile and non-sterile active pharmaceutical ingredients. Helen acted as the subject matter expert for topics including contamination control, environmental monitoring, aseptic process and equipment validation and water systems.

Helen joined Ecolab in 2019 as a Global Technical Consultant for Ecolab Life Sciences, advising on application and use of specialist cleanroom biocides in line with current regulatory guidance and industry best practice.
 

Henrietta Vinneras

Senior Manager, Microbiology & Aseptic Technique, Fresenius Kabi
Henrietta Vinneras

Mrs Vinnerås has been in the industry since year 2000 and has worked for pharmaceutical and medical device companies such as Pfizer, Abbott, GE Healthcare, Thermo Fisher Scientific and currently at Fresenius Kabi. Mrs Vinnerås is part of a global competence center supporting mainly the companys’ pharmaceutical manufacturing, medical devices and compounding centers world-wide with e.g. establishing global corporate procedures, on-site assessments, education and training, trouble shooting, root cause investigations, CAPAs and continuous improvement projects; specifically within the areas of microbiology and aseptic technique. She is also a member of the PDA Journal of Pharmaceutical Sciences and Technology editorial board.

Ian Ramsay

Independent Quality Consultant, RamsayPharma
Ian Ramsay

He has a Degree in Microbiology and joined the industry in 2004, with GlaxoSmithKline where he spent 8 years in a number of roles within QC and QA. He spent significant time within front line QA roles supporting a range of different products and dose forms- including steriles, non-steriles, tablets, capsules, topicals, injectables, inhaled products and biologics. This role culminated in a global QA function where Ian spent 2 years supporting inspection readiness and providing oversite for multiple vaccine manufacturing sites worldwide.

After spending time in industry, Ian spent 4 years as an MHRA GMDP inspector. This role saw Ian responsible for planning and executing inspections worldwide across a wide range of products and dose forms. In this time, Ian specialised in data integrity and unlicensed aseptic operations. Ian also spent significant time managing serious non-compliance cases through the formal regulatory process (IAG) and is experienced in site remediation activities.

As a consultant, Ian has assisted multiple companies worldwide across a diverse range of dose forms. RamsayPharma offers comprehensive support in the areas of consulting, audit and remediation.

James Drinkwater

PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
James Drinkwater

F Ziel Head of GMP Compliance and Aseptic process integration. James is also an honorary member of the Not-for Profit Pharmaceutical and Healthcare Sciences Society: PHSS, Leading the PHSS Aseptic processing and Bio-contamination special interest groups and Annex 1 Focus group. James is Pharmaceutical process engineer with additional education in Pharmaceutical microbiology with a career spanning over 35 years in Pharmaceutical manufacturing and Aseptic processing technologies. Additional association memberships include the Pharmaceutical Quality Group (PQG) UK and ISPE.

Jim Polarine Jr

Senior Global Technical Service Manager, Steris Corporation
Jim Polarine Jr

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

Johannes Oberdoerfer

Lead Scientist, Rapid Microbiology Methods, Boehringer Ingelheim Pharma GmbH & Co. KG
Johannes Oberdoerfer

The pharmaceutical company Boehringer Ingelheim was founded in 1885 by Albert Boehringer in Ingelheim am Rhein. From its beginnings in 1885 the company has since become a global enterprise with more than 50 000 employees.
Boehringer Ingelheim BioXcellence™ is a world-leading biopharmaceutical contract manufacturer with tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to fill and finish under one roof.
The Endotoxin testing lab has the challenge of managing and testing a large number of water samples on a daily basis, making it necessary for microbiology lab analysts to perform water endotoxin/LAL testing. The Endosafe® Nexus™ robotic endotoxin/LAL testing system combines a proven cartridge-based LAL technology (the multi-cartridge system, or MCS™) with a robotic system that carries and dilutes samples all the way through to completion. The Endosafe® Nexus™ system increases the laboratory throughput and efficiency while reducing potential pipetting variability and data entry errors with its sample bar code reader and ability to communicate with Labware LIMS.
 

Joseph McCall

Associate Director, QA Technical Service , ADMA Biologics
Joseph McCall

Joe McCall, SM (NRCM) is the Associate Director of Quality Assurance Technical Services at ADMA Biologics in Boca Raton, FL. He has over 25 years of experience as a professional microbiologist at such companies as Bausch & Lomb, Genzyme, DSM Pharmaceuticals, STERIS Life Sciences, and Mass Biologics. Joe has been an active industry member throughout his career, teaching courses at PDA TRI, the University of Tennessee HSC, and providing training at FDA CBER Division of Product Quality and Manufacturing. Joe has delivered training seminars in pharmaceutical microbiology for companies in Europe, Asia, South America, and across the US. He has been a contributing member of PDA for over 15 years and is one of the few ASM Certified Specialists in Pharmaceutical and Medical Device Microbiology on the National Registry of Certified Microbiologists.

Juliana Nassette

Team Lead QC Microbiology, Kite Pharma
Juliana Nassette

I have finished my bachelor degree and post- graduation in Biomedical Sciences specializing myself in Microbiology at the Jean Piaget University in Portugal.
In 2010 I have moved to The Netherlands where I worked at Crucell B.V., today know as J&J Janssen Vaccines for a bit over 3 years and got introduced to Environmental Monitoring and contamination control.
After that I have spent roughly 5 years in R&D at 2 different companies still in the area of contamination control but got more in depth with biocidal products for disinfection and preservation of materials.
End of 2019 I have joined Kite Pharma and got back to my origins in the pharmaceutical industry, where I became the Team Lead of the Microbiology department where part of the responsibilities are the strategy around Environmental Control and Monitoring.
 

Philippe Dhoms

Head of Bioprocess Development and Industrialisation, Boehringer-Ingelheim
Philippe  Dhoms

Tony Cundell

Principal Consultant, Microbiological Consulting, LLC
Tony Cundell

Dr. Tony Cundell consults with a number of pharmaceutical, consumer health and dietary supplement companies, microbiology instrument manufacturers, contract testing laboratories and sterile compounding pharmacies in the areas of microbial risk assessment, regulatory affairs, and microbiological testing. Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, Tony Cundell worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.

He is a member of the 2020-2025 U.S.P. Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods, co-chairing the USP Expert Panel that published a stimuli article in the Sept-Oct. 2017 Pharmacopeial Forum entitled The Development of Compendial Rapid Sterility Tests.

Tony Cundell chaired the PDA task force responsible for the ground-breaking 2000 Technical Report No. 33 The Development, Validation, and Implementation of New (Rapid) Microbiological Methods. In June 2009, he co-edited with Anthony Fontana a book entitled Water Activity Applications in the Pharmaceutical Industry and contributed two chapters to the book. He was co-chair of the PDA task force responsible for 2014 Technical Report No. 67 Exclusion of Objectionable Microorganisms from Non-Sterile Drug Products. In 2015 he was appointed to the Advisory Committee of Sterile Compounding to the State of Massachusetts Board of Pharmacy. He received the 2016 PDA Martin Van Trieste Pharmaceutical Science Award for outstanding contributions to the advancement of pharmaceutical science.

More recently Tony Cundell co-authored a review article entitled Controls To Minimize Disruption of the Pharmaceutical Supply Chain During the Covid-19 Pandemic that was published in the July-August, 2020 issue of the PDA J. Pharm. Sci. & Technol.
 

Sponsors and Exhibitors

Official Media Partner

Supporters

VENUE

Copthorne Tara Hotel

Scarsdale Place, Kensington, London, United Kingdom

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

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

 

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

Sponsors and Exhibitors


Ecolab

Sponsors and Exhibitors
https://en-uk.ecolab.com/

Ecolab’s Life Sciences division is dedicated to developing the best possible products and services to support our customers in the pharmaceutical industry.

Our comprehensive solutions and technical expertise are focused on cleaning, sanitisation and contamination control, all while ensuring safety, compliance and operational efficiency.


Media Partners


Genetic Engineering News

Official Media Partner
http://www.genengnews.com

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


Biocompare

Official Media Partner
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.


Rapid Microbiology.com

Official Media Partner
https://www.rapidmicrobiology.com

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


American Pharmaceutical Review

Official Media Partner
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

Media Partners


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.


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.


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.


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.


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!


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.


Gate2Biotech

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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.


Mednous

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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


IPI

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http://www.ipimediaworld.com

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


MedTube

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https://medtube.net/



Pharmalicensing

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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.


World Pharma News

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http://www.worldpharmanews.com/



SciDoc Publishers

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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.


pharmaphorum

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http://www.pharmaphorum.com

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

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Copthorne Tara Hotel

Scarsdale Place
Kensington
London W8 5SR
United Kingdom

Copthorne Tara Hotel

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

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

 

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WHAT IS CPD?

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

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

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

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

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

CPD AND PROFESSIONAL INSTITUTES

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

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

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

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

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

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

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

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

As a formal provider of CPD certified activities, 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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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
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