Pharma Microbiology Congress 2024
Panoramica della conferenza
STRATEGIES AND INNOVATION TECHNOLOGIES IN STERILE MANUFACTURING
The Pharma Microbiology Congress is the European annual meeting point of professionals involved in the sterile manufacturing of medicinal products and medical device.
A full immersion on the latest regulatory updates, new technologies for the detection and containment of contamination, best practice and strategies to improve the sterility assurance of the manufacturing and control of sterile medicines.
Professionals belonging to different areas of expertise (Production, Engineering, Quality Control, Quality Assurance, R&D, Maintenance) will get together to share and discuss the hottest topics with experts coming from Regulatory Bodies, Pharmaceutical Companies, Consultancy, Associations and New Technologies providers.
The program will see the contribution of international Top Speakers as experts, key opinion leaders and representatives of institutions.
Road to Pharma Microbiology Congress 2024 – IN PROGRESS
FOLLOW THE ROAD TO PMC 2024
The initiative will see us and the sponsors working in synergy before the conference by organizing a series of thematic webinars and interviews: subscribe to the LinkedIn page and don’t miss them! Click here
Format del congresso
VIRTUAL + FACE TO FACE
Last year the mixed format reached a great success, so this year as well the first two days, October 28 and 29, will be virtual and will see the participation of worldwide experts and key opinion leaders.
The third day, November 8, will be a face-to-face meeting in Florence, where you will have the chance to meet colleagues and the speakers of the conference: a great opportunity for the sterile manufacturing community to get together!
Perchè partecipare?
EXPERTS & KOLs OF THE FIELD WILL SHARE THEIR EXPERIENCES AND KNOW HOW:
From regulatory issues to the most technical aspects, our speakers will share their deep expertise with the audience through speeches, round tables and question times: ask questions, rate the ones coming from the audience and let us know what is important for you to know.
STAY UPDATED ON THE LATEST TECHNOLOGIES AND TECHNOLOGICAL ADVANCES
Each day, a session dedicated to new technologies and technological advances that are changing the world of sterile manufacturing. Don’t miss webinars, interviews and demonstrations, and chat with real experts of the field.
FOLLOW THE ROAD TO PMC2024
The initiative will see us and the sponsors working in synergy before the conference by organizing a series of thematic webinars and interviews: subscribe to the LinkedIn page and don’t miss them! Click here
A chi è rivolto?
The event is aimed specifically at Pharma, Biotech and Medical Device Companies, Regulatory bodies and Technology Suppliers involved in the manufacturing and control of Sterile medicines.
Featured Topics 2023 – TOPICS 2024 IN PROGRESS
VIRTUAL 8 Novembre
Regulatory landscape and gmp inspection trends
INNOVATION TECHNOLOGIES WEBINARS
CCS: regulatory expectations & not sterile case studies
INNOVATION TECHNOLOGIES WEBINARS
Environmental & process monitoring
VIRTUAL 9 Novembre
Contamination risk control
INNOVATION TECHNOLOGIES WEBINARS
PERSONNEL: Qualification, Training & Innovation
INNOVATION TECHNOLOGIES WEBINARS
BIOTECH/ATMP: regulatory trends & innovation technologies
FATE-TO-FACE IN MILAN 14 Novembre
Facility design of the future: How to address Annex 1 requirements?
Advanced sterile manufacturing | Enhancement of sterile manufacturing
Enhancement of sterility assurance in processes
Innovation technologies session
Advanced sterile controls | Enhancement of sterility assurance in controls
Workshop & Q&A Time with experts
8 November 2023 – VIRTUAL
Lucia Costanzo, Senior Conference Manager | PEC & Pharma Microbiology Congress chairperson
Gabriele Gori, SVP Global Quality Operations and Chief Quality Officer | Biogen International GMBH, Chair Science Advisory Board PDA
Alan Moon, Director of AM GMP Limited and former Lead Senior GMDP Inspector at MHRA
Isabel Hoenen, Quality Advisor for Sterility Assurance | Eli Lilly France
Di Morris, Qualified Person/ Quality Compliance Advisor | PNR Pharma Consulting Ltd
Angela Petrigliano, Operational Manager Process & Quality | Pharma D&S, a Product Life Group Company
Francesco Boschi, Senior Manager Technical Services QTO Sterile Injectables & Biotech | Pfizer Global Supply
Tracy Moore, Director at TM Pharma Group Ltd and former MHRA Expert EU GMDP inspector
Andrea Stefano Ivaldi, Product Marketing and Business Development Manager | COPAN
Walid El Azab, Industrial Pharmacist, Senior Manager and Qualified Person
9 November 2023 – VIRTUAL
J. Drinkwater, Head of the PHSS Aseptic processing and Annex 1 focus groups
Giancarla Cecere, Microbiology and Sterility Assurance specialist | IMA
Alessandra Benassi, Microbiology and Sterility Assurance specialist | IMA
Veronika Wills, Associate Director, Global Technical Services | Associates of Cape Cod, Inc.
Elena Secchi, Technical Sales Representative | Associates of Cape Cod, Inc.
Matthew Stevenson, European Sales Manager | Associates of Cape Cod, Inc.
Antonio Pierno, Senior Manager – SLS – MSAT filtration team | Cytiva
Andrea Pranti, Qualification Transformation Engineering Manager | GSK Vaccines
Mauro Giusti, Senior Director, Parenteral Technical Knowledge | Eli Lilly Italia,President PDA Italy Chapter
Paola Lazzeri, Technical Sales Manager Europe | Veltek Associates, Inc.
Francesco Cicirello, Quality Compliance BioNTainer (Ex PIC/S SCH Deputy Chair, EMA IWG Representative and Annex 2 WG Chair – TGA Expert Inspector) | BioNTech US Inc.
Satyakam Singh, Director, Head of Cell Therapy Process and Analytical Development | Simnova Biotechnology
Krisha Patel, Co-Founder of Assurea LLC
Maria Paola Baini, Associate Director, Quality-Strategic Growth Investment & Engineering | Lonza
14 November 2023 – FACE-TO-FACE IN MILAN
Lucia Costanzo, Senior Conference Manager | PEC & Pharma Microbiology Congress chairperson
Alfonso Annunziata, Senior GMP Inspector Medicinal Products | AIFA
Marco Conti, CEO di C&P Engineering, Pharma D&S Group, a Product Life Group Company
Mirko Gabriele, Pharma Innovation and Strategies Advisor, PDA Board of Director, PDA Italy Chapter President-Elect
Orazio Cultrera, Pharmaceutical Industries Consultant | Cultrera Consulting
Silvia Calloni, Project Manager Education & Training | PEC
Andrea Tanzini, Local Head of Business – Pharma & Medical – Italy | Staubli Robotics
Filippo Parini, Area Sales Manager | STERILINE
Steven Higgins, Global Technical Lead Validations | Rapid Micro Biosystem
Greta Franzoso, Quality Compliance Manager/Quality Assurance | Stevanato Group
Laurent Leblanc, R&D Manager | bioMérieux Healthcare business
Lucia Costanzo, Senior Conference Manager | PEC & Pharma Microbiology Congress chairperson
Tim Sandle, Pharmaceutical Microbiologist & Contamination Control Expert -Bio Product Laboratory Limited
Tracy Moore, Director at TM Pharma Group Ltd and former MHRA Expert EU GMDP inspector
Alan Moon, Director of AM GMP Limited and former Lead Senior GMDP Inspector at MHRA
Fernanda Ferrazin, Life Sciences Expert
Stefano Scorsini, Experienced Advisor in Industrial Pharmaceutical Technologies and Quality System management / QP and Lead Auditor | Pharma D&S, a Product Life Group Company
Speakers 2023 – SPEAKERS 2024 IN PROGRESS
Alfonso Annunziata
Senior GMP Inspector Medicinal Products | AIFA
Tiziana Archilletti
Quality Unit Director | Biomedica Foscama and Special Product’s Line
Alessandra Benassi
Microbiology and Sterility Assurance specialist | IMA
Francesco Boschi
Senior Manager Technical Services QTO Sterile Injectables & Biotech | Pfizer Global Supply
Giancarla Cecere
Microbiology and Sterility Assurance specialist | IMA
Lucia Ceresa
Board PDA Italy Chapter
Francesco Cicirello
Senior Director, Quality Compliance BioNTainer (Ex PIC/S SCH Deputy Chair, EMA IWG Representative and Annex 2 WG Chair – TGA Expert Inspector) | BioNTech US Inc.
Marco Conti
CEO of C&P Engineering, Pharma D&S, a Product Life Group Company
Adriana Elsa Cotti
Consultant Quality Expert & QP | C&P Engineering – Pharma D&S Group, a Product Life Group Company
James Drinkwater
Head of the PHSS Aseptic processing and Annex 1 focus groups
Walid El Azab
Industrial Pharmacist and Qualified Person
Fernanda Ferrazin
Life Sciences Expert
Greta Franzoso
Quality Compliance Manager/Quality Assurance | Stevanato Group
Mirko Gabriele
Pharma Innovation and Strategies Advisor, PDA Board of Director, PDA Italy Chapter President-Elect
Mauro Giusti
Senior Director Parenteral Technical Knowledge | Eli Lilly Italia, President PDA Italy Chapter
Gabriele Gori
SVP Global Quality Operations and Chief Quality Officer | Biogen International GMBH, Chair Science Advisory Board PDA
Steven Higgins
Global Technical Lead Validations | Rapid Micro Biosystem
Isabelle Hoenen
Quality Advisor for Sterility Assurance | Eli Lilly France
Andrea Stefano Ivaldi
Product Marketing and Business Development Manager | COPAN
Paola Lazzeri
Technical Sales Manager Europe | Veltek Associates, Inc.
Laurent Leblanc
R&D Manager | bioMérieux Healthcare business
Tracy Moore
Director | TM Pharma Group Ltd and former MHRA Expert EU GMDP inspector
Alan Moon
Director of AM GMP Limited and former Lead Senior GMDP Inspector at MHRA
Di Morris
Qualified Person/Quality Compliance Advisor | PNR Pharma Consulting Ltd., PHSS Vice-Chair
Patrizia Muscas
Sterility Assurance Sr Research Scientist Global TS.MS | Eli Lilly and Company
Filippo Parini
Area Sales Manager | STERILINE
Krisha Patel
Co-Founder of Assurea LLC
Angela Petrigliano
Operational Manager Process & Quality | Pharma D&S Group
Antonio Pierno
Senior Manager – SLS – MSAT filtration team | Cytiva-PALL
Andrea Pranti
Qualification Transformation Engineering Manager | GSK Vaccines
William H. Miele
Senior Director, Global Aseptic Support | Pfizer, Retired, Consulting LLC
Tim Sandle
Pharmaceutical Microbiologist & Contamination Control Expert | Bio Product Laboratory Limited
Stefano Scorsini
Experienced Advisor in Industrial Pharmaceutical Technologies and QUality System Management / Qualified Person and Lead Auditor | Pharma D&S
Elena Secchi
Technical Sales Representative | Associates of Cape Cod, Inc.
Michele Simone
Corporate Quality Director | Bracco Group, PDA Regulatory Affairs and Quality Assurance Board (RAQAB) member
Satyakam Singh
Director, Head of Cell Therapy Process and Analytical Development | Simnova Biotechnology
Matthew Stevenson
European Sales Manager | Associates of Cape Cod, Inc.
Andrea Tanzini
Local Head of Business – Pharma & Medical – Italy | Staubli Robotics
Filippo Trionfera
Quality Operation Manager & Qualified Person | BSP Pharmaceuticals, PDA Italy Chapter
Veronika S. Wills
Associate Director, Global Technical Services | Associates of Cape Cod, Inc.
Maria Paola Baini
Associate Director, Quality-Strategic Growth Investment & Engineering | Lonza
Orazio Cultrera
Pharmaceutical Industries Consultant | Cultrera Consulting, Steering Committee PDA Italy Chapter
SPONSORS 2024 IN PROGRESS
Associates of Cape Cod, Inc.
Silver Sponsor
Associates of Cape Cod, Inc.
Silver Sponsor
Specialising in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod International, Inc. (ACC) has been a global leader in endotoxin and (1→3)-ß-D-glucan detection products and services for nearly 50 years.
ACC pioneered LAL testing methodology and was the first FDA licenced company to manufacture LAL reagents and has grown to be an internationally recognised leader in endotoxin detection. Most recently, ACC introduced the first and only commercially available sustainable BET Recombinant Cascade Reagent (rCR), PyroSmart NextGen®.
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BioItalia
Silver Sponsor
BioItalia
Silver Sponsor
Società specializzata nel proporre mantenere ed implementare soluzioni per l’automazione del laboratorio e rilevazione rapida dei microrganismi.
Nata di recente dalla lunga esperienza internazionale dei soci fondatori nel settore del controllo microbiologico che viene messa al servizio dei clienti per migliorare la produttività del Laboratorio.
BioMérieux
Gold Sponsor
BioMérieux
Gold Sponsor
A global leader in in vitro diagnostics for more than 55 years, bioMérieux has always been driven by a pioneering spirit and unrelenting commitment to provide innovative diagnostic solutions that improve patient health and ensure consumer safety. The patient has always been at the center of our strategy of developing products with high medical and economic value. In guiding the Company’s development, bioMérieux has always focused on meeting healthcare challenges all over the world. In a world where viruses and bacteria know no borders, our international outreach is an integral part of bioMérieux’s history. Today, we are present in 43 countries and serve more than 160 countries. We also have 19 bio-industrial sites and 20 R&D centers worldwide.
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C&P Engineering
Silver Sponsor
C&P Engineering
Silver Sponsor
C&P Engineering s.r.l. is a consulting and engineering services company operating in the sector of chemical-pharmaceutical, nutraceutical, medical (medical devices), cosmetics industries and other sectors (microelectronics, aerospace and optics).
C&P develops the design and the implementation of controlled contamination environments (Clean Rooms), service facilities (HVAC and technological fluids).
C&P qualifies and validates the various critical systems, be they process, service or computerised systems.
C&P provides support for efficient energy management and correct waste disposal.
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Charles River
Silver Sponsor
Charles River
Silver Sponsor
As the partner of choice for managing microbial quality control, the Charles River purposely-built Microbial Solutions portfolio of Endosafe® endotoxin testing, Accugenix® microbial identification and Celsis® microbial detection solutions provides clients with the critical, decision-driving data necessary to help bring products to market safely and efficiently.
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Copan
Gold Sponsor
Copan
Gold Sponsor
NewLab is one of the newest Copan business units, aiming to provide technologically advanced automated solutions for industrial microbiology. The NewLab innovative approach enables companies and laboratories to benefit from efficient sample processing that guarantees solid quality performance.
PharmaLab™, is our platform designed specifically for pharmaceutical industries, capable of digital plate incubation and reading for environmental monitoring to offer reliable results through any audit trail.
NewLab is ready to deal with any request and tailor solutions to your needs in today’s fast-paced technological scene. Considered a strategic technological partner, Copan NewLab supports any of your complex projects.
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Euroclone
Exhibitor
Euroclone
Exhibitor
Euroclone continues its evolution as a modern supplier of products not only distributed but also under its own brand, thus reconfiguring its key supplier position for a large number of research laboratories, medical, clinical and industrial centers, with the same passion and willingness to improve, but above all as a collaborative partner for those who work in the biotechnology world.
Euroclone provides innovative products, services and solutions for Molecular and Cell Biology, Genomics, Proteomics, Cytogenetics and Agro-Food Diagnostics.From the choice of high-quality products to the after sales service, Euroclone is your reliable and solid partner for your scientific challenges.
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Lighthouse
Gold Sponsor
Lighthouse
Gold Sponsor
Lighthouse is the leading global provider of laser-based headspace analysis systems and measurement services. Headspace applications include container closure integrity testing, monitoring of headspace oxygen during filling and stability studies, determination of water activity, lyo cycle optimization, chamber moisture mapping, and automated media fill inspection.
Lighthouse offers a range of benchtop and in-line platforms with patented laser sensor technology, which was commercialized with the help of funding from the Food and Drug Administration. Additionally, analytical services are delivered from laboratory facilities in Amsterdam, the Netherlands, and Charlottesville, the United States, which include method development and analytical process and product studies
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Mesa Labs
Exhibitor
Mesa Labs
Exhibitor
Known globally for our experience and expertise, Mesa Labs manufactures AAMI-, ISO-, and USP-compliant indicators for a wide range of sterilization modalities with over 40 years of industry experience. Our products and custom solutions offer convenient and consistent ways to validate and monitor the compliance of your processes and products. Our indicators support an array of sterilization processes, and include strips, discs, ampoules, self-contained, suspension, UniQ, and custom options. Our Apex® Biological Indicators are the top of the line for vaporized hydrogen peroxide bio-decontamination processes of isolators, RABS and clean rooms. Our Contract Study Lab is specialized in bioburden and product D-value assessments for pharmaceutical products and substrates (stoppers, elastomers) as well as your partner in developing customized Biological Indicators for unique situations.
At Mesa Labs, we are committed to protecting the vulnerable™
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Pharma D&S
Silver Sponsor
Pharma D&S
Silver Sponsor
Pharma D&S is an European Service Provider active in Lifescience field with a panel of more than 180 consultants who provide and support pharmaceutical companies in Pharmacovigilance, Clinical Research, Regulatory Affairs and Quality needs. We are partner whit over 400 companies by managing different areas of the product’s entire lifecycle and our customers can find a range of services and a multidisciplinary activities. We believe in the Relationship and client’s Loyalty, in understanding and sharing their goals, integrating with their staff and processes. We trust People, fostering their growth and promoting their commitment. We believe in Innovation and Creativity, in seeking constantly new approaches, ideas and solutions.
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QS Group
Silver Sponsor
QS Group
Silver Sponsor
QS Group SrL, your partner for calibration services of critical process instrumentation, validation services of processes and systems and sale of instruments, equipment and accessories for contamination control.
With 10 years in the field, with a targeted approach to innovation and research thanks to numerous experiences and collaborations; QS Group Srl is based in Milan and has offices in central Italy, Switzerland and France.
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Rapid Micro Biosystems
Gold Sponsor
Rapid Micro Biosystems
Gold Sponsor
Rapid Micro Biosystems® (RMB) creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. The company’s Growth Direct® is the only fully automated, non-destructive growth-based system for multiple QC test applications: environmental monitoring, water, and bioburden. Automating rapid compendial QC micro testing ensures data integrity, compliance, and operational efficiencies. RMB is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.
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RIGEL
Exhibitor
RIGEL
Exhibitor
Established in 2008, RIGEL Life Sciences is a provider offering the very best solutions while meeting and exceeding the needs of client engineering and GMP compliance teams within the Life Science Industries.
RIGEL Life Sciences is the right partner when the outcome must be Full Compliance. With expertise spanning the quality spectrum, we specialize in the management, monitoring and validation of contamination levels within clean environments.
RIGEL Life Sciences will provide the correct solution unique to your requirements; whether your facility manufactures electronics or pharmaceuticals products or provides healthcare directly to patients.
Rigel is the first worldwide manufacturer to have developed a new generation monitoring system, IEMS Next, able to comply/exceed the performances requested by the ISO 14644-2:2015, with particular reference to:
• integration of multiple instruments;
• superior real-time characterization of the area being monitored;
• rapid assessment of the alert and action levels;
• statistical trend analysis of the rare events;
• fully optimized reporting for a comprehensive events’ analysis.
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Veltek
Exhibitor
Veltek
Exhibitor
For nearly 40 years, Veltek Associates, Inc. (VAI®) has pioneered the design and manufacture of hundreds of cleanroom solutions that surround contamination control.
These innovations, many of them landmarks in the industry’s history, allow our customers to overcome challenges and reach their business goals.
VAI clients have more than a solutions provider, they have a partner and trusted advisor. With today’s complex research challenges, new competition, and increasing government regulations, a true partnership is more important than ever.
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Vileda
Exhibitor
Vileda
Exhibitor
Vileda Professional offers innovative solutions and cleaning systems for professional use in various application areas, in particular healthcare and clean rooms. It is present worldwide, with subsidiaries in European countries and an extensive network of representatives. Vileda Professional belongs to the Freudenberg Group, a diversified family-owned company with headquarters in Germany. The specific cleanroom range focuses on products that provide effective cleaning and full contamination control, key elements for safe and efficient production (pharmaceutical, biomedical, laboratories). Vileda Professional is at the forefront in controlled environments’ cleaning process, offering functional and autoclavable tools.
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Rapid Microbiology
Media Partner
Rapid Microbiology
Media Partner
Rapid Microbiology is a well-established on-line resource for microbiologists worldwide. Find the right products for your microbiology lab using our specially designed search functions. 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.
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Diventa sponsor
The Pharma Microbiology Congress 2024 provides an excellent opportunity to get in touch with microbiology/sterility assurance professionals and decision makers. To sponsor the event, contact us!
Sede del congresso
Step 1
On October 28-29 the event will be VIRTUAL to grant you the possibility of joining the conference even from your office or home, wherever you may be.
We have organized a true virtual location, a space where you will be able to:
- Follow the live streaming of the congress, listen to experts and opinion makers and be informed about latest trends and technological breakthroughs in sterile manufacturing
- Visit the VIRTUAL EXHIBITION AREA and all the stands of our sponsors
- Join Q&A times and round tables to discuss the current hot topics in the field
- Chat with our sponsors and learn about new technologies and services to ease your daily work and increase the performance
Step 2
Let’s finally meet face to face in Florence on November 8! A great chance to meet in person the PMC experts and colleagues. The conference will be hosted in the wonderful spaces of Palazzo degli Affari, right in the heart of Florence.
Panoramica della conferenza
STRATEGIES AND INNOVATION TECHNOLOGIES IN STERILE MANUFACTURING
The Pharma Microbiology Congress is the European annual meeting point of professionals involved in the sterile manufacturing of medicinal products and medical device.
A full immersion on the latest regulatory updates, new technologies for the detection and containment of contamination, best practice and strategies to improve the sterility assurance of the manufacturing and control of sterile medicines.
Professionals belonging to different areas of expertise (Production, Engineering, Quality Control, Quality Assurance, R&D, Maintenance) will get together to share and discuss the hottest topics with experts coming from Regulatory Bodies, Pharmaceutical Companies, Consultancy, Associations and New Technologies providers.
The program will see the contribution of international Top Speakers as experts, key opinion leaders and representatives of institutions.
Road to Pharma Microbiology Congress 2024 - IN PROGRESS
FOLLOW THE ROAD TO PMC 2024
The initiative will see us and the sponsors working in synergy before the conference by organizing a series of thematic webinars and interviews: subscribe to the LinkedIn page and don’t miss them! Click here
Format del congresso
VIRTUAL + FACE TO FACE
Last year the mixed format reached a great success, so this year as well the first two days, October 28 and 29, will be virtual and will see the participation of worldwide experts and key opinion leaders.
The third day, November 8, will be a face-to-face meeting in Florence, where you will have the chance to meet colleagues and the speakers of the conference: a great opportunity for the sterile manufacturing community to get together!
Perchè partecipare?
EXPERTS & KOLs OF THE FIELD WILL SHARE THEIR EXPERIENCES AND KNOW HOW:
From regulatory issues to the most technical aspects, our speakers will share their deep expertise with the audience through speeches, round tables and question times: ask questions, rate the ones coming from the audience and let us know what is important for you to know.
STAY UPDATED ON THE LATEST TECHNOLOGIES AND TECHNOLOGICAL ADVANCES
Each day, a session dedicated to new technologies and technological advances that are changing the world of sterile manufacturing. Don’t miss webinars, interviews and demonstrations, and chat with real experts of the field.
FOLLOW THE ROAD TO PMC2024
The initiative will see us and the sponsors working in synergy before the conference by organizing a series of thematic webinars and interviews: subscribe to the LinkedIn page and don’t miss them! Click here
A chi è rivolto?
The event is aimed specifically at Pharma, Biotech and Medical Device Companies, Regulatory bodies and Technology Suppliers involved in the manufacturing and control of Sterile medicines.
Featured Topics 2023 - TOPICS 2024 IN PROGRESS
VIRTUAL 8 Novembre
Regulatory landscape and gmp inspection trends
INNOVATION TECHNOLOGIES WEBINARS
CCS: regulatory expectations & not sterile case studies
INNOVATION TECHNOLOGIES WEBINARS
Environmental & process monitoring
VIRTUAL 9 Novembre
Contamination risk control
INNOVATION TECHNOLOGIES WEBINARS
PERSONNEL: Qualification, Training & Innovation
INNOVATION TECHNOLOGIES WEBINARS
BIOTECH/ATMP: regulatory trends & innovation technologies
FATE-TO-FACE IN MILAN 14 Novembre
Facility design of the future: How to address Annex 1 requirements?
Advanced sterile manufacturing | Enhancement of sterile manufacturing
Enhancement of sterility assurance in processes
Innovation technologies session
Advanced sterile controls | Enhancement of sterility assurance in controls
Workshop & Q&A Time with experts
8 November 2023 - VIRTUAL
Lucia Costanzo, Senior Conference Manager | PEC & Pharma Microbiology Congress chairperson
Gabriele Gori, SVP Global Quality Operations and Chief Quality Officer | Biogen International GMBH, Chair Science Advisory Board PDA
Alan Moon, Director of AM GMP Limited and former Lead Senior GMDP Inspector at MHRA
Isabel Hoenen, Quality Advisor for Sterility Assurance | Eli Lilly France
Di Morris, Qualified Person/ Quality Compliance Advisor | PNR Pharma Consulting Ltd
Angela Petrigliano, Operational Manager Process & Quality | Pharma D&S, a Product Life Group Company
Francesco Boschi, Senior Manager Technical Services QTO Sterile Injectables & Biotech | Pfizer Global Supply
Tracy Moore, Director at TM Pharma Group Ltd and former MHRA Expert EU GMDP inspector
Andrea Stefano Ivaldi, Product Marketing and Business Development Manager | COPAN
Walid El Azab, Industrial Pharmacist, Senior Manager and Qualified Person
9 November 2023 - VIRTUAL
J. Drinkwater, Head of the PHSS Aseptic processing and Annex 1 focus groups
Giancarla Cecere, Microbiology and Sterility Assurance specialist | IMA
Alessandra Benassi, Microbiology and Sterility Assurance specialist | IMA
Veronika Wills, Associate Director, Global Technical Services | Associates of Cape Cod, Inc.
Elena Secchi, Technical Sales Representative | Associates of Cape Cod, Inc.
Matthew Stevenson, European Sales Manager | Associates of Cape Cod, Inc.
Antonio Pierno, Senior Manager – SLS – MSAT filtration team | Cytiva
Andrea Pranti, Qualification Transformation Engineering Manager | GSK Vaccines
Mauro Giusti, Senior Director, Parenteral Technical Knowledge | Eli Lilly Italia,President PDA Italy Chapter
Paola Lazzeri, Technical Sales Manager Europe | Veltek Associates, Inc.
Francesco Cicirello, Quality Compliance BioNTainer (Ex PIC/S SCH Deputy Chair, EMA IWG Representative and Annex 2 WG Chair – TGA Expert Inspector) | BioNTech US Inc.
Satyakam Singh, Director, Head of Cell Therapy Process and Analytical Development | Simnova Biotechnology
Krisha Patel, Co-Founder of Assurea LLC
Maria Paola Baini, Associate Director, Quality-Strategic Growth Investment & Engineering | Lonza
14 November 2023 - FACE-TO-FACE IN MILAN
Lucia Costanzo, Senior Conference Manager | PEC & Pharma Microbiology Congress chairperson
Alfonso Annunziata, Senior GMP Inspector Medicinal Products | AIFA
Marco Conti, CEO di C&P Engineering, Pharma D&S Group, a Product Life Group Company
Mirko Gabriele, Pharma Innovation and Strategies Advisor, PDA Board of Director, PDA Italy Chapter President-Elect
Orazio Cultrera, Pharmaceutical Industries Consultant | Cultrera Consulting
Silvia Calloni, Project Manager Education & Training | PEC
Andrea Tanzini, Local Head of Business – Pharma & Medical – Italy | Staubli Robotics
Filippo Parini, Area Sales Manager | STERILINE
Steven Higgins, Global Technical Lead Validations | Rapid Micro Biosystem
Greta Franzoso, Quality Compliance Manager/Quality Assurance | Stevanato Group
Laurent Leblanc, R&D Manager | bioMérieux Healthcare business
Lucia Costanzo, Senior Conference Manager | PEC & Pharma Microbiology Congress chairperson
Tim Sandle, Pharmaceutical Microbiologist & Contamination Control Expert -Bio Product Laboratory Limited
Tracy Moore, Director at TM Pharma Group Ltd and former MHRA Expert EU GMDP inspector
Alan Moon, Director of AM GMP Limited and former Lead Senior GMDP Inspector at MHRA
Fernanda Ferrazin, Life Sciences Expert
Stefano Scorsini, Experienced Advisor in Industrial Pharmaceutical Technologies and Quality System management / QP and Lead Auditor | Pharma D&S, a Product Life Group Company
Speakers 2023 - SPEAKERS 2024 IN PROGRESS
Alfonso Annunziata
Senior GMP Inspector Medicinal Products | AIFA
Tiziana Archilletti
Quality Unit Director | Biomedica Foscama and Special Product’s Line
Alessandra Benassi
Microbiology and Sterility Assurance specialist | IMA
Francesco Boschi
Senior Manager Technical Services QTO Sterile Injectables & Biotech | Pfizer Global Supply
Giancarla Cecere
Microbiology and Sterility Assurance specialist | IMA
Lucia Ceresa
Board PDA Italy Chapter
Francesco Cicirello
Senior Director, Quality Compliance BioNTainer (Ex PIC/S SCH Deputy Chair, EMA IWG Representative and Annex 2 WG Chair – TGA Expert Inspector) | BioNTech US Inc.
Marco Conti
CEO of C&P Engineering, Pharma D&S, a Product Life Group Company
Adriana Elsa Cotti
Consultant Quality Expert & QP | C&P Engineering – Pharma D&S Group, a Product Life Group Company
James Drinkwater
Head of the PHSS Aseptic processing and Annex 1 focus groups
Walid El Azab
Industrial Pharmacist and Qualified Person
Fernanda Ferrazin
Life Sciences Expert
Greta Franzoso
Quality Compliance Manager/Quality Assurance | Stevanato Group
Mirko Gabriele
Pharma Innovation and Strategies Advisor, PDA Board of Director, PDA Italy Chapter President-Elect
Mauro Giusti
Senior Director Parenteral Technical Knowledge | Eli Lilly Italia, President PDA Italy Chapter
Gabriele Gori
SVP Global Quality Operations and Chief Quality Officer | Biogen International GMBH, Chair Science Advisory Board PDA
Steven Higgins
Global Technical Lead Validations | Rapid Micro Biosystem
Isabelle Hoenen
Quality Advisor for Sterility Assurance | Eli Lilly France
Andrea Stefano Ivaldi
Product Marketing and Business Development Manager | COPAN
Paola Lazzeri
Technical Sales Manager Europe | Veltek Associates, Inc.
Laurent Leblanc
R&D Manager | bioMérieux Healthcare business
Tracy Moore
Director | TM Pharma Group Ltd and former MHRA Expert EU GMDP inspector
Alan Moon
Director of AM GMP Limited and former Lead Senior GMDP Inspector at MHRA
Di Morris
Qualified Person/Quality Compliance Advisor | PNR Pharma Consulting Ltd., PHSS Vice-Chair
Patrizia Muscas
Sterility Assurance Sr Research Scientist Global TS.MS | Eli Lilly and Company
Filippo Parini
Area Sales Manager | STERILINE
Krisha Patel
Co-Founder of Assurea LLC
Angela Petrigliano
Operational Manager Process & Quality | Pharma D&S Group
Antonio Pierno
Senior Manager – SLS – MSAT filtration team | Cytiva-PALL
Andrea Pranti
Qualification Transformation Engineering Manager | GSK Vaccines
William H. Miele
Senior Director, Global Aseptic Support | Pfizer, Retired, Consulting LLC
Tim Sandle
Pharmaceutical Microbiologist & Contamination Control Expert | Bio Product Laboratory Limited
Stefano Scorsini
Experienced Advisor in Industrial Pharmaceutical Technologies and QUality System Management / Qualified Person and Lead Auditor | Pharma D&S
Elena Secchi
Technical Sales Representative | Associates of Cape Cod, Inc.
Michele Simone
Corporate Quality Director | Bracco Group, PDA Regulatory Affairs and Quality Assurance Board (RAQAB) member
Satyakam Singh
Director, Head of Cell Therapy Process and Analytical Development | Simnova Biotechnology
Matthew Stevenson
European Sales Manager | Associates of Cape Cod, Inc.
Andrea Tanzini
Local Head of Business – Pharma & Medical – Italy | Staubli Robotics
Filippo Trionfera
Quality Operation Manager & Qualified Person | BSP Pharmaceuticals, PDA Italy Chapter
Veronika S. Wills
Associate Director, Global Technical Services | Associates of Cape Cod, Inc.
Maria Paola Baini
Associate Director, Quality-Strategic Growth Investment & Engineering | Lonza
Orazio Cultrera
Pharmaceutical Industries Consultant | Cultrera Consulting, Steering Committee PDA Italy Chapter
SPONSORS 2024 IN PROGRESS
Associates of Cape Cod, Inc.
Silver Sponsor
Associates of Cape Cod, Inc.
Silver Sponsor
Specialising in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod International, Inc. (ACC) has been a global leader in endotoxin and (1→3)-ß-D-glucan detection products and services for nearly 50 years.
ACC pioneered LAL testing methodology and was the first FDA licenced company to manufacture LAL reagents and has grown to be an internationally recognised leader in endotoxin detection. Most recently, ACC introduced the first and only commercially available sustainable BET Recombinant Cascade Reagent (rCR), PyroSmart NextGen®.
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BioItalia
Silver Sponsor
BioItalia
Silver Sponsor
Società specializzata nel proporre mantenere ed implementare soluzioni per l’automazione del laboratorio e rilevazione rapida dei microrganismi.
Nata di recente dalla lunga esperienza internazionale dei soci fondatori nel settore del controllo microbiologico che viene messa al servizio dei clienti per migliorare la produttività del Laboratorio.
BioMérieux
Gold Sponsor
BioMérieux
Gold Sponsor
A global leader in in vitro diagnostics for more than 55 years, bioMérieux has always been driven by a pioneering spirit and unrelenting commitment to provide innovative diagnostic solutions that improve patient health and ensure consumer safety. The patient has always been at the center of our strategy of developing products with high medical and economic value. In guiding the Company’s development, bioMérieux has always focused on meeting healthcare challenges all over the world. In a world where viruses and bacteria know no borders, our international outreach is an integral part of bioMérieux’s history. Today, we are present in 43 countries and serve more than 160 countries. We also have 19 bio-industrial sites and 20 R&D centers worldwide.
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C&P Engineering
Silver Sponsor
C&P Engineering
Silver Sponsor
C&P Engineering s.r.l. is a consulting and engineering services company operating in the sector of chemical-pharmaceutical, nutraceutical, medical (medical devices), cosmetics industries and other sectors (microelectronics, aerospace and optics).
C&P develops the design and the implementation of controlled contamination environments (Clean Rooms), service facilities (HVAC and technological fluids).
C&P qualifies and validates the various critical systems, be they process, service or computerised systems.
C&P provides support for efficient energy management and correct waste disposal.
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Charles River
Silver Sponsor
Charles River
Silver Sponsor
As the partner of choice for managing microbial quality control, the Charles River purposely-built Microbial Solutions portfolio of Endosafe® endotoxin testing, Accugenix® microbial identification and Celsis® microbial detection solutions provides clients with the critical, decision-driving data necessary to help bring products to market safely and efficiently.
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Copan
Gold Sponsor
Copan
Gold Sponsor
NewLab is one of the newest Copan business units, aiming to provide technologically advanced automated solutions for industrial microbiology. The NewLab innovative approach enables companies and laboratories to benefit from efficient sample processing that guarantees solid quality performance.
PharmaLab™, is our platform designed specifically for pharmaceutical industries, capable of digital plate incubation and reading for environmental monitoring to offer reliable results through any audit trail.
NewLab is ready to deal with any request and tailor solutions to your needs in today’s fast-paced technological scene. Considered a strategic technological partner, Copan NewLab supports any of your complex projects.
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Euroclone
Exhibitor
Euroclone
Exhibitor
Euroclone continues its evolution as a modern supplier of products not only distributed but also under its own brand, thus reconfiguring its key supplier position for a large number of research laboratories, medical, clinical and industrial centers, with the same passion and willingness to improve, but above all as a collaborative partner for those who work in the biotechnology world.
Euroclone provides innovative products, services and solutions for Molecular and Cell Biology, Genomics, Proteomics, Cytogenetics and Agro-Food Diagnostics.From the choice of high-quality products to the after sales service, Euroclone is your reliable and solid partner for your scientific challenges.
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Lighthouse
Gold Sponsor
Lighthouse
Gold Sponsor
Lighthouse is the leading global provider of laser-based headspace analysis systems and measurement services. Headspace applications include container closure integrity testing, monitoring of headspace oxygen during filling and stability studies, determination of water activity, lyo cycle optimization, chamber moisture mapping, and automated media fill inspection.
Lighthouse offers a range of benchtop and in-line platforms with patented laser sensor technology, which was commercialized with the help of funding from the Food and Drug Administration. Additionally, analytical services are delivered from laboratory facilities in Amsterdam, the Netherlands, and Charlottesville, the United States, which include method development and analytical process and product studies
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Mesa Labs
Exhibitor
Mesa Labs
Exhibitor
Known globally for our experience and expertise, Mesa Labs manufactures AAMI-, ISO-, and USP-compliant indicators for a wide range of sterilization modalities with over 40 years of industry experience. Our products and custom solutions offer convenient and consistent ways to validate and monitor the compliance of your processes and products. Our indicators support an array of sterilization processes, and include strips, discs, ampoules, self-contained, suspension, UniQ, and custom options. Our Apex® Biological Indicators are the top of the line for vaporized hydrogen peroxide bio-decontamination processes of isolators, RABS and clean rooms. Our Contract Study Lab is specialized in bioburden and product D-value assessments for pharmaceutical products and substrates (stoppers, elastomers) as well as your partner in developing customized Biological Indicators for unique situations.
At Mesa Labs, we are committed to protecting the vulnerable™
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Pharma D&S
Silver Sponsor
Pharma D&S
Silver Sponsor
Pharma D&S is an European Service Provider active in Lifescience field with a panel of more than 180 consultants who provide and support pharmaceutical companies in Pharmacovigilance, Clinical Research, Regulatory Affairs and Quality needs. We are partner whit over 400 companies by managing different areas of the product’s entire lifecycle and our customers can find a range of services and a multidisciplinary activities. We believe in the Relationship and client’s Loyalty, in understanding and sharing their goals, integrating with their staff and processes. We trust People, fostering their growth and promoting their commitment. We believe in Innovation and Creativity, in seeking constantly new approaches, ideas and solutions.
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QS Group
Silver Sponsor
QS Group
Silver Sponsor
QS Group SrL, your partner for calibration services of critical process instrumentation, validation services of processes and systems and sale of instruments, equipment and accessories for contamination control.
With 10 years in the field, with a targeted approach to innovation and research thanks to numerous experiences and collaborations; QS Group Srl is based in Milan and has offices in central Italy, Switzerland and France.
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Rapid Micro Biosystems
Gold Sponsor
Rapid Micro Biosystems
Gold Sponsor
Rapid Micro Biosystems® (RMB) creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. The company’s Growth Direct® is the only fully automated, non-destructive growth-based system for multiple QC test applications: environmental monitoring, water, and bioburden. Automating rapid compendial QC micro testing ensures data integrity, compliance, and operational efficiencies. RMB is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.
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RIGEL
Exhibitor
RIGEL
Exhibitor
Established in 2008, RIGEL Life Sciences is a provider offering the very best solutions while meeting and exceeding the needs of client engineering and GMP compliance teams within the Life Science Industries.
RIGEL Life Sciences is the right partner when the outcome must be Full Compliance. With expertise spanning the quality spectrum, we specialize in the management, monitoring and validation of contamination levels within clean environments.
RIGEL Life Sciences will provide the correct solution unique to your requirements; whether your facility manufactures electronics or pharmaceuticals products or provides healthcare directly to patients.
Rigel is the first worldwide manufacturer to have developed a new generation monitoring system, IEMS Next, able to comply/exceed the performances requested by the ISO 14644-2:2015, with particular reference to:
• integration of multiple instruments;
• superior real-time characterization of the area being monitored;
• rapid assessment of the alert and action levels;
• statistical trend analysis of the rare events;
• fully optimized reporting for a comprehensive events’ analysis.
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Veltek
Exhibitor
Veltek
Exhibitor
For nearly 40 years, Veltek Associates, Inc. (VAI®) has pioneered the design and manufacture of hundreds of cleanroom solutions that surround contamination control.
These innovations, many of them landmarks in the industry’s history, allow our customers to overcome challenges and reach their business goals.
VAI clients have more than a solutions provider, they have a partner and trusted advisor. With today’s complex research challenges, new competition, and increasing government regulations, a true partnership is more important than ever.
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Vileda
Exhibitor
Vileda
Exhibitor
Vileda Professional offers innovative solutions and cleaning systems for professional use in various application areas, in particular healthcare and clean rooms. It is present worldwide, with subsidiaries in European countries and an extensive network of representatives. Vileda Professional belongs to the Freudenberg Group, a diversified family-owned company with headquarters in Germany. The specific cleanroom range focuses on products that provide effective cleaning and full contamination control, key elements for safe and efficient production (pharmaceutical, biomedical, laboratories). Vileda Professional is at the forefront in controlled environments’ cleaning process, offering functional and autoclavable tools.
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Rapid Microbiology
Media Partner
Rapid Microbiology
Media Partner
Rapid Microbiology is a well-established on-line resource for microbiologists worldwide. Find the right products for your microbiology lab using our specially designed search functions. 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.
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Diventa sponsor
The Pharma Microbiology Congress 2024 provides an excellent opportunity to get in touch with microbiology/sterility assurance professionals and decision makers. To sponsor the event, contact us!
Sede del congresso
Step 1
On October 28-29 the event will be VIRTUAL to grant you the possibility of joining the conference even from your office or home, wherever you may be.
We have organized a true virtual location, a space where you will be able to:
- Follow the live streaming of the congress, listen to experts and opinion makers and be informed about latest trends and technological breakthroughs in sterile manufacturing
- Visit the VIRTUAL EXHIBITION AREA and all the stands of our sponsors
- Join Q&A times and round tables to discuss the current hot topics in the field
- Chat with our sponsors and learn about new technologies and services to ease your daily work and increase the performance
Step 2
Let’s finally meet face to face in Florence on November 8! A great chance to meet in person the PMC experts and colleagues. The conference will be hosted in the wonderful spaces of Palazzo degli Affari, right in the heart of Florence.
Iscriviti alla conferenza
Face to Face (8/11/24) |
450€ |
Virtual (28-29/10/24) |
750€ |
Virtual + Face to Face (28-29/10/24 e 8/11/24) |
1100€ |
* Ospedali, università e liberi professionisti ottengono uno sconto del 40% da applicare ai prezzi pubblicati (gli sconti non sono cumulabili).