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SMi’s 3rd Annual Conference
Pharmaceutical Microbiology East Coast
April 29th – 30th, 2020 | Boston, USA
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The pharmaceutical microbiology industry has seen many changes during the progression into the 21st century. With advances in rapid microbiological methods, revisions being made to regulations in the industry, enhanced knowledge of the human microbiome, and novel testing methods, innovative approaches in ATMP facilities, this industry is ever expanding.

Join industry experts to discuss and analyze the latest advances and challenges within the industry. Network with industry professionals, discuss revisions in regulatory and guidance documents, explore data integrity considerations for conventional and rapid microbiology methods, analyze arising issues with environmental monitoring to best control contamination and gain insight into an industry perspective on automated endotoxin testing and process automation.
 

HIGHLIGHTS FOR 2020:
Discuss ongoing complication of personnel derived contaminations from the FDA
Gain valuable insight towards microbiological quality considerations in non-sterile manufacturing and control of BCC from Parexel
Learn from the perspective of the US Pharmacopeia on container closure integrity evaluation
Examine an end-to-end contamination risk assessment for autologous cell therapy from Juno Therapeutics
Explore a back to back Genentech session covering technical considerations for microbial QC of raw materials used in biotechnology and the past, current and future state of Mycoplasma testing

• Senior Microbiologist
• Lead Scientist
• Laboratory Manager
• QA Specialist
• Drug Substance External Manufacturer
• QC Scientists
• Heads of Quality
• Business Development Manager
• Pharmaceutical Microbiology Consultant
• Higher Pharmacopoeial Scientist
• Analytical Standards Specialist

 

Amneal Pharmaceutical; Amneal Pharmaceuticals LLC; Analytical Lab Group LLC; Associates of Cape Cod; Association of Cape Cod, Inc; Atara Biotherapeutics; Banelle; Baxter Corporation; bioMerieux Industry; bioMerieux, Inc.; Bioscience International; BioTekPro AB; Biotherpeutics; BioVigilant Systems; Bristol Myers Squibb; Charles River; CTL - Mat; DuPont; DuPont de Nemours Luxembourg sarl; Dupont Personal Protection; Eagle Analytical Services (Former FDA); Eli Lilly And Company; Emergent Biosolutions; Genentech; ImmuneBiotech AB; Infinity Laboratories; InnovaPrep; International Serum Industry Association; Ipsen; Lantheus Medical Imaging; Lonza; Lonza Walkersville, Inc.; Merck; Meridian Medical Technologies; Mettler Toledo; Microbiological Consulting, LLC; Microrite, Inc.; Novartis Pharmaceuticals Corporation; Novatek International; Ocular Therapeutix; Organogenesis Holdings Incorporated; Pfizer; Pfizer Inc; Pharmaceutical and Healthcare Sciences Society; Pharmalucence, Inc.; Regeneron; Regeneron Pharmaceuticals Inc.; Sanofi; Sanofi Genzyme; SCA Pharma; Seres Therapeutics; Steris Corporation; Sun Pharma Boston; Takeda; Takeda Pharmaceuticals; United Therapeutics; University Of Calgary; University Of Guelph; University of Veterinary Medicine Vienna; Vericel Corporation; Zeteo Tech LLC;

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Lynne Ensor

Lynne Ensor, Vice President, Technical, Parexel International
View Bio

9:10 Microbiological Quality Considerations in Non-sterile Pharmaceutical Manufacture and Control of BCC

Lynne Ensor

Lynne Ensor, Vice President, Technical, Parexel International
View Bio

• Introduction of the FDA’s impending guidance on this topic
• Regulatory Expectations for microbial control of non-sterile drugs
• Case studies of microbiological contamination of non-sterile drug products to demonstrate the impact on product quality and the manufacturing process
 

9:50 Evaluating the ongoing complications of personnel derived contaminations

Maria Jose Lopez Barragan

Maria Jose Lopez Barragan, CMC Product Quality Reviewer, FDA

• Understanding a key microbial reservoir: the human microbiome and a regulatory update of cleanliness expectations
• Discussing personnel behaviour, training and cleanroom garment and fabric considerations
• Exploring the current utility of robotics and automation in controlled environments
• Future outlook
 

10:30 Morning Coffee

11:00 Container Closure Integrity Evaluation: USP Perspective

Leslie Furr

Leslie Furr, Associate Scientific Liaison, US Pharmacopeial Convention
View Bio

• Historical considerations of CCI testing
• Overview and application of USP’s guidance on package integrity testing
• Stakeholder engagement: Hot topics, industry needs, future direction
 

11:40 Monocyte Activation Test: The In-vitro Pyrogen Test Based on Human Immune Cells for Batch Release Testing of Medical Products

Shabnam Solati

Shabnam Solati, Co-Founder, CEO, CTL - Mat
View Bio

• Presenting the MAT as a robust, reproducible, sensitive and human specific pyrogen testing
• An end-to-end process: MAT kit generation, test performance and product-specific validation
• Presenting the solution to the recent EP criteria: MAT as risk assessment for the endotoxin test and replacement of RPT
• The solution for pyrogenicity tests of medical devices
 

12:20 Networking Lunch

13:20 Mycoplasma Testing: Past, Current, and Future State

Kenneth Tai

Kenneth Tai, QC Scientist, Genentech
View Bio

• Compendial Methods
• Real-Time PCR testing, Considerations
• At-line Testing and Next Generation Sequencing
 

14:00 Alternative methods for endotoxin testing: focus on equivalency of recombinant reagents to lysate reagents

Veronika Wills

Veronika Wills, Manager, Technical Services, Associates of Cape Cod
View Bio

• Status of recombinant reagents as alternate tests
• Requirements for alternate reagents
• Comparability testing of recombinant reagents
 

14:40 Afternoon Tea

15:10 Adopting the rFC (recombinant Factor C) assay for endotoxin detection in your laboratory

Lakiya Wimbish

Lakiya Wimbish, Product Manager, Lonza
View Bio

• Why switch to rFC testing?
• Comparable data to traditional LAL endotoxin assays;
• Validation that meets regulatory requirements;
• Sustainability
 

15:50 Emphasis on laboratory data integrity deficiencies and compliance

Chinmoy Roy

Chinmoy Roy, Senior Consultant, Valgensis Inc,
View Bio

• Frequency of non-compliant regulatory findings and FDA warning letters
• Reassessing the definitions of data integrity and the current analytical and statistical methods to detect anomalies
• Conducting a Laboratory Data Integrity Risk Assessment using Process Flow Charts
• Risk-based case studies showcasing multiple approaches
 

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

Lynne Ensor

Lynne Ensor, Vice President, Technical, Parexel International
View Bio

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Lynne Ensor

Lynne Ensor, Vice President, Technical, Parexel International
View Bio

9:10 Culturing Contamination Prevention - Building a Sustainable Microbial Control Program from the Ground Up

• Drivers for establishment of a successful microbial contamination control program (CCP)
• Implementation of a company’s CCP will be outlined, emphasizing the importance of perspective and partnership between local/global functions
• Focus on CCP sustainability and continuous improvement for contamination prevention
• Case studies/examples of identified best practices and lessons learned will be presented
 

Hilary Chan

Hilary Chan, Principal QC Scientist, Takeda (Shire)
View Bio

Maria Dunnells

Maria Dunnells, Right First Time Program Manager, Takeda Pharmaceuticals
View Bio

9:50 Technical Considerations for Microbial Quality Control

Elia Sanchez

Elia Sanchez, QC Microbiology Sr. Manager, Genentech
View Bio

• Basics in Microbial Testing of Raw Materials
• Chemical Interactions in Bacteriology
• Case Studies on Microbial Control: Microbial resilience and adaptation
 

10:30 Morning Coffee

11:00 A Comprehensive, User-friendly and Sustainable Endotoxin Testing Solution

Brendan Tindall

Brendan Tindall, Global Solutions Manager and Program Director, BioMeríeux

11:40 End-to-End Contamination Risk Assessment for Autologous

Rebecca Jordan

Rebecca Jordan, QC Specialist, Celgene
View Bio

• Case study for designing a comprehensive contamination
• risk assessment for a cell therapy manufacturing facility
• How the risk assessment informs other programs such as environmental monitoring and deviation response
 

12:20 Networking Lunch

13:20 Microbial Control Strategies for Pharmacy Compounding Facilities

Steve Walton

Steve Walton, Technical Manager - Sterility Assurance, Sanofi Pasteur
View Bio

• Comparison of regulatory standards for aseptic drug product manufacturing and sterile pharmacy compounding operations
• Developing and implementing a microbial control strategy
 

14:00 Monitoring and treatment of pharmaceutical waters in multidrug manufacturing facilities

14:40 Afternoon Tea

15:10 Common Myths and Urban Legend Regarding Cleaning and Disinfection

James N. Polarine Jr

James N. Polarine Jr, Senior Technical Service Manager, Steris Corporation
View Bio

• Isopropanol kills everything
• Cleaning more often will resolve the contamination
• Residues from disinfectants will inhibit sporicides
 

15:50 Learning Outcomes from Aseptic Audit Observations

Kashyap Bhatt

Kashyap Bhatt, Senior QA Auditor, Ipsen

• Outlining the auditor’s expectations
• Determine which audit finding classifications could be utilized
• Notable examples of recent audit observations
• Ensuring compliance
 

16:30 Chair’s Closing Remarks and Close of Day Two

Lynne Ensor

Lynne Ensor, Vice President, Technical, Parexel International
View Bio

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FEATURED SPEAKERS

Chinmoy Roy

Chinmoy Roy

Senior Consultant, Valgensis Inc,
Elia Sanchez

Elia Sanchez

QC Microbiology Sr. Manager, Genentech
Hilary Chan

Hilary Chan

Principal QC Scientist, Takeda (Shire)
James N. Polarine Jr

James N. Polarine Jr

Senior Technical Service Manager, Steris Corporation
Kenneth Tai

Kenneth Tai

QC Scientist, Genentech
Lakiya Wimbish

Lakiya Wimbish

Product Manager, Lonza
Leslie Furr

Leslie Furr

Associate Scientific Liaison, US Pharmacopeial Convention
Lynne Ensor

Lynne Ensor

Vice President, Technical, Parexel International
Maria Dunnells

Maria Dunnells

Right First Time Program Manager, Takeda Pharmaceuticals
Rebecca Jordan

Rebecca Jordan

QC Specialist, Celgene
Shabnam Solati

Shabnam Solati

Co-Founder, CEO, CTL - Mat
Steve Walton

Steve Walton

Technical Manager - Sterility Assurance, Sanofi Pasteur
Veronika Wills

Veronika Wills

Manager, Technical Services, Associates of Cape Cod

Brendan Tindall

Global Solutions Manager and Program Director, BioMeríeux
Brendan Tindall

Chinmoy Roy

Senior Consultant, Valgensis Inc,
Chinmoy Roy

Chinmoy Roy is a retiree from Genentech. He is an experienced biopharmaceutical consultant with subject matter expertise in CSV, Data Integrity, CFR 21 Part 11, Annex 11 and manufacturing process automation systems. He is a member of ISPE’s Data Integrity Special Interest Group (S.I.G). His presentations blend his field experience to highlight the intricacies of implementing regulations. Chinmoy has a bachelor’s degree in Electrical Engineer and a Masters degree in Computer Science.

Elia Sanchez

QC Microbiology Sr. Manager, Genentech
Elia Sanchez

Elia Sanchez has a BS in Biology, a Master’s Degree in Environmental Health and a PhD. in Environmental Microbiology from the University of Puerto Rico. Elia began her journey in the Pharmaceutical Industry 13 years ago working for Amgen for 10 years, and she currently works in Genentech-Roche in SF California, as the Sr. Manager of the Microbiology Quality Control Laboratory. Elia has experience leading multiple teams, projects, investigations, new product introductions, as well as managing regulatory inspections. Elia loves the beach, wine tasting in Napa-Sonoma, likes to cook, and loves spending time with her Twin Boys (now College kids).

Hilary Chan

Principal QC Scientist, Takeda (Shire)
Hilary Chan

Hilary Chan is a Principal Quality Control Scientist in Global Microbiology Management at Takeda and is based out of Lexington, MA. In her current role, Hilary is responsible for leading various technical improvement initiatives related to microbiological issues/contamination control for Takeda’s global manufacturing operations. She is a business process owner for environmental monitoring as well as a contamination control community of practice network lead for Takeda. She is an invited speaker at industry conferences and has authored various scientific publications. Hilary has 19 years of experience in the biotech industry and holds a Bachelor’s degree in Zoology from Colorado State University and a Master’s degree in Biomedical Science from Northeastern University.

James N. Polarine Jr

Senior Technical Service Manager, Steris Corporation
James N. Polarine Jr

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for nineteen 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 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’s Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is current President 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.

Jeanne Moldenhauer

Vice President, Excellent Pharma Consulting Inc
Jeanne Moldenhauer

Kashyap Bhatt

Senior QA Auditor, Ipsen
Kashyap Bhatt

Kenneth Tai

QC Scientist, Genentech
Kenneth Tai

Kenneth received his Ph.D. in genetics, molecular, and cell biology. After graduation, he began his career at Life Technologies (now Thermofisher) where he worked on Real-time PCR assays, reagents, and instruments. In 2014, he started his career at Genentech for the global adventitious agents testing group. His focus is on method transfer and validation of real-time PCR-based assays for Mycoplasma, MVM, and Leptospira. He is currently evaluating Next Generation Sequencing as a viable option to replace current tests.

Lakiya Wimbish

Product Manager, Lonza
Lakiya Wimbish

Lakiya Wimbish is a Product Manager for Endotoxin Detection at Lonza, with a primary focus on alternative methods like the recombinant Factor C Assay and other rapid microbial detection platforms. She joined Lonza in 2007 as an Applications Development Scientist before transitioning into her current role. Prior to Lonza, Lakiya was a contractor for the United States Navy’s Biological Defense Research Directorate, developing QC PCR-based assays for the detection of bio-warfare agents in the field.

Leslie Furr

Associate Scientific Liaison, US Pharmacopeial Convention
Leslie Furr

Leslie Furr is an Associate Scientific Liaison to the Compendial Science-General Chapters group at the United States Pharmacopeial Convention. She has been with USP since 2018 where she is a liaison to the Packaging and Distribution, Dosage Forms, and Microbiology Expert Committees. Before becoming a liaison at USP she was an Expert Committee volunteer for the Chemical Medicines group with expertise in antibiotic testing. She holds a certification from the American Society for Microbiology as a Specialist Microbiologist in Pharmaceutical and Medical Device since 2012. Prior to working at USP, she was a Senior Microbiologist in the pharmaceutical industry where she spent 14 years in method development, R&D, and manufacturing support for non-sterile products. She obtained her B.S. in Microbiology from the University of North Carolina at Charlotte and her M.S. in Pharmaceutical Sciences at the University of Florida.

Lynne Ensor

Vice President, Technical, Parexel International
Lynne Ensor

Dr. Lynne Ensor is a Vice President, Technical, for Parexel. As a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/OPQ/CDER, responsible for new, generic, and biologic drug product quality review and facility assessment. Her previous FDA management positions include serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the OPS’s New and Generic Drug Product Quality Microbiology staff, and Director of OGD’s Division of Microbiology. Lynne was previously employed at Roche Biomedical Laboratories, the University of Maryland at Baltimore’s School of Medicine, and earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park.

Maria Dunnells

Right First Time Program Manager, Takeda Pharmaceuticals
Maria Dunnells

Maria Dunnells is a Right First Time Program Manager in the Manufacturing department at Takeda based out of Lexington, MA. In her current role, Maria represents the contamination control program for the Massachusetts Biologics manufacturing facilities. As part of this role, she drives the site’s strategy for contamination reduction through project ownership, leads the site contamination control team, and represents the site in the global contamination control community of practice. Maria has 7 years of experience in the biotech industry and holds a Bachelor’s degree in Chemical Engineering and a Master’s degree in Biotechnology, both from Northeastern University.

Maria Jose Lopez Barragan

CMC Product Quality Reviewer, FDA
Maria Jose Lopez Barragan

Rebecca Jordan

QC Specialist, Celgene
Rebecca Jordan

Rebecca Jordan is a Sr. Microbiology Specialist at Celgene's West Coast CAR-T manufacturing facility, where she focuses on the multifaceted discipline of contamination control. She has over 10 years’ experience in industry as a QC Microbiologist, where she has supported both large and small manufacturing firms, commercial facility start-up, development through licensure of parenteral drugs, facility and utilities monitoring, APS, investigations CAPA, and quality risk management to name a few. She has also successfully navigated global regulatory audits, developed and implemented aseptic training programs, established EM trend and disinfectant efficacy programs, and consulted on new facility design projects for CAR-T therapy manufacturing. She is a keen investigator whose curiosity and dedication has led to a diverse and rewarding career. She holds a B.S. in Biology from Fitchburg State University.

Shabnam Solati

Co-Founder, CEO, CTL - Mat
Shabnam Solati

Shabnam Solati developed a Monocyte Activation Test to meet all the end-to-end MAT needs in the industry, with pyrogen detection and quantification levels that are unprecedented. With the expertise of MAT and the knowledge regarding all the test’s potential abilities, Shabnam is dedicated to build the future of MAT even beyond where it is today. Therefore, research, development and innovative technologies are continuous focus points at CTL-MAT.

Steve Walton

Technical Manager - Sterility Assurance, Sanofi Pasteur
Steve Walton

Steve Walton is an ASQ Certified Pharmaceutical GMP Professional with more than 11 years’ experience in microbiology, sterility assurance, contamination control, and aseptic processing. Steve has served in facilities with terminal sterilization (Baxter Corp.), aseptic drug product manufacturing (Alcon/CIBA Vision, a Novartis company), biotechnology (Sanofi Pasteur), and is currently serving at a commercial compounding pharmacy (Baxter Corp.)

 

Veronika Wills

Manager, Technical Services, Associates of Cape Cod
Veronika Wills

Veronika has been working in the endotoxin industry for the past 12 years and currently manages the Technical Services department at Associates of Cape Cod, Inc. Veronika is a specialist on testing complex samples, method development, regulatory aspects of endotoxin testing, development and delivery of educational and technical contents. She attends and speaks frequently at scientific conferences and seminars globally and is an established expert on endotoxin testing. Veronika holds a Master’s Degree in Biochemical Engineering from the Institute of Chemical Technology in Prague, Czech Republic.

 

Sponsors

Official Media Partner

Supporters

VENUE

Sheraton Boston Hotel

39 Dalton Street, Boston, MA, USA

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

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

Chair Letter Invite - Lynne Ensor

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Conference Program

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Conference Speakers with Biographies

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Past Attendee List (2018-2019)

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Workshop Program

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Pharmaceutical Microbiology East Coast 2020 Brochure

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Past Presentation 2019 - Pfizer

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Past Presentation 2019 - Roche

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Past Presentation 2019 - Eli Lilly and Company

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Past Presentation 2019 - BioTekPro AB

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Past Presentation 2019 - PHSS

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Past Presentation 2019 - Steris

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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.biomerieux-usa.com/biopharma

bioMérieux, Inc. helps our clients unlock greater value from their organizations with expert consultation and a complete line of diagnostic solutions that enable more rapid, confident results. Clients benefit from improved productivity and profitability by minimizing errors and reducing time to result, as well as brand protection and safer and healthier consumer products.


CTL-MAT

Sponsors
http://WWW.CTLMAT.COM

CTL-MAT - The MAT Company has been established to serve any and all of your Monocyte Activation Test needs, offering MAT Kits, Pooled PBMC, Batch Release Testing, Product-specific Validation and Consultation Services. The MAT is the only quantitative, in-vitro, true pyrogen test - measuring endotoxins and non-endotoxin pyrogens alike.


Lonza

Sponsors
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.

Media Partners


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.


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


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.


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

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.


pharmaphorum

Supporters
http://www.pharmaphorum.com

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


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.


CanBiotech

Supporters
http://www.canbiotech.com

CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


IBI - International Biopharmaceutical Industry

Supporters
http://www.biopharmaceuticalmedia.com

IBI - International Biopharmaceutical Industry, provides the biopharmaceutical industry with comprehensive coverage of key scientific, technology, regulatory and business topics. The editorial mix of peer-reviewed papers, practical advice on managing bioprocessing and technology, regulatory and business columns, and expert commentary provides comprehensive coverage of upstream and downstream processing, manufacturing operations, regulations, formulation, scale-up/technology transfer, drug delivery, analytical testing and more. The insight and analysis covers biologic – based therapies including We will report on emerging trends, strategies and best practices in the key areas.


pharmanews hq

Supporters
http://http://pharmanewshq.com

MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


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


Labcompare

Supporters
http://www.labcompare.com

Labcompare is a product of American Laboratory, and is already included in the AL logo on your website. I have attached the standalone Labcompare logo and info is below, but if you do add this one separately, could you exchange the American Lab logo with the one attached? For laboratory managers and researcher scientists across analytical chemistry and applied sciences who need to find product solutions, advice, and access scientific tools. Labcompare provides an industry-leading, comprehensive, online resource of product information to support the laboratory’s needs. Labcompare supports every step of the buying journey by focusing on core and new product technology, supplies, tips, and buyer’s guides.


IPI

Supporters
http://www.ipimediaworld.com

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


Farmavita

Supporters
https://farmavitar.com

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


BioChem Adda

Supporters
https://www.biochemadda.com/

BioChem Adda is a Not-just-for-Profit organization which aims to bring out the most reliable and transparent information about everything related to jobs, careers, education, news, articles, and events from the field of BioSciences and Chemistry!


Drug Target Review

Supporters
http://www.drugtargetreview.com

Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.


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.


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.


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.


Journal for Clinical Studies

Supporters
http://www.jforcs.com

JCS – Journal for Clinical Studies is peer reviewed. Supported by a team of industry experts, JCS brings you contemporary and authoritative articles which will guide the industry in the best practice in regulatory issues, market analysis, drug discovery, development, drug design, clinical research, data analysis, safety and efficacy, recruitment and retention, laboratories, analytical testing, custom and contract manufacturing, primary and secondary packaging and logistics and supply chain management.


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.


Pharmiweb

Supporters
http://www.pharmiweb.com

Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.

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Sheraton Boston Hotel

39 Dalton Street
Boston 02199
USA

Sheraton Boston Hotel

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

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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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