Pharma Microbiology Congress 2024

28-29 October 2024
Online
English
 
8 November 2024
Face to face in FLORENCE
English
 

Conference overview

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

Congress Format

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 8will 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!

Why attend?

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

Who should attend?

The event is aimed specifically at PharmaBiotech and Medical Device CompaniesRegulatory bodies and Technology Suppliers involved in the manufacturing and control of Sterile medicines.

Featured Topics 2023 - TOPICS 2024 IN PROGRESS

VIRTUAL 8 November

Regulatory landscape and gmp inspection trends
INNOVATION TECHNOLOGIES WEBINARS
CCS: regulatory expectations & not sterile case studies
INNOVATION TECHNOLOGIES WEBINARS
Environmental & process monitoring

VIRTUAL 9 November
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 November
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


SESSION 1. ANNEX 1 IMPLEMENTATION: REGULATORY LANDSCAPE

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

SESSION 2. CCS: MANAGING THE GAPS & NOT STERILE APPLICATION

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

SESSION 3. ENVIRONMENTAL & PROCESS MONITORING

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


SESSION 4. CONTAMINATION RISK CONTROL

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

SESSION 5. PERSONNEL: INNOVATION, QUALIFICATION & TRAINING

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.

SESSION 6. BIOTECH/ATMP: REGULATORY TRENDS & INNOVATION TECHNOLOGIES

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


SESSION 7. FACILITY DESIGN FOR THE FUTURE ANNEX 1: HOW TO ADDRESS THE REQUIREMENTS?

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

SESSION 8. ADVANCED STERILE IN MANUFACTURING & CONTROLS

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

SESSION 9. ANNEX 1 WORKSHOP

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

Alfonso Annunziata

Senior GMP Inspector Medicinal Products | AIFA

Tiziana Archilletti

Tiziana Archilletti

Quality Unit Director | Biomedica Foscama and Special Product’s Line

Alessandra Benassi

Alessandra Benassi

Microbiology and Sterility Assurance specialist | IMA

Francesco Boschi

Francesco Boschi

Senior Manager Technical Services QTO Sterile Injectables & Biotech | Pfizer Global Supply

Giancarla Cecere

Giancarla Cecere

Microbiology and Sterility Assurance specialist | IMA

Lucia Ceresa

Lucia Ceresa

Board PDA Italy Chapter

Francesco Cicirello

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

Marco Conti

CEO of C&P Engineering, Pharma D&S, a Product Life Group Company

Adriana Elsa Cotti

Adriana Elsa Cotti

Consultant Quality Expert & QP | C&P Engineering – Pharma D&S Group, a Product Life Group Company

James Drinkwater

James Drinkwater

Head of the PHSS Aseptic processing and Annex 1 focus groups

Walid El Azab

Walid El Azab

Industrial Pharmacist and Qualified Person

Fernanda Ferrazin

Fernanda Ferrazin

Life Sciences Expert

Greta Franzoso

Greta Franzoso

Quality Compliance Manager/Quality Assurance | Stevanato Group

Mirko Gabriele

Mirko Gabriele

Pharma Innovation and Strategies Advisor, PDA Board of Director, PDA Italy Chapter President-Elect

Mauro Giusti

Mauro Giusti

Senior Director Parenteral Technical Knowledge | Eli Lilly Italia, President PDA Italy Chapter

Gabriele Gori

Gabriele Gori

SVP Global Quality Operations and Chief Quality Officer | Biogen International GMBH, Chair Science Advisory Board PDA

Steven Higgins

Steven Higgins

Global Technical Lead Validations | Rapid Micro Biosystem

Isabelle Hoenen

Isabelle Hoenen

Quality Advisor for Sterility Assurance | Eli Lilly France

Andrea Stefano Ivaldi

Andrea Stefano Ivaldi

Product Marketing and Business Development Manager | COPAN

Paola Lazzeri

Paola Lazzeri

Technical Sales Manager Europe | Veltek Associates, Inc.

Laurent Leblanc

Laurent Leblanc

R&D Manager | bioMérieux Healthcare business

Tracy Moore

Tracy Moore

Director | TM Pharma Group Ltd and former MHRA Expert EU GMDP inspector

Alan Moon

Alan Moon

Director of AM GMP Limited and former Lead Senior GMDP Inspector at MHRA

Di Morris

Di Morris

Qualified Person/Quality Compliance Advisor | PNR Pharma Consulting Ltd., PHSS Vice-Chair

Patrizia Muscas

Patrizia Muscas

Sterility Assurance Sr Research Scientist Global TS.MS | Eli Lilly and Company

Filippo Parini

Filippo Parini

Area Sales Manager | STERILINE

Krisha Patel

Krisha Patel

Co-Founder of Assurea LLC

Angela Petrigliano

Angela Petrigliano

Operational Manager Process & Quality | Pharma D&S Group

Antonio Pierno

Antonio Pierno

Senior Manager – SLS – MSAT filtration team | Cytiva-PALL

Andrea Pranti

Andrea Pranti

Qualification Transformation Engineering Manager | GSK Vaccines

William H. Miele

William H. Miele

Senior Director, Global Aseptic Support | Pfizer, Retired, Consulting LLC

Tim Sandle

Tim Sandle

Pharmaceutical Microbiologist & Contamination Control Expert | Bio Product Laboratory Limited

Stefano Scorsini

Stefano Scorsini

Experienced Advisor in Industrial Pharmaceutical Technologies and QUality System Management / Qualified Person and Lead Auditor | Pharma D&S

Elena Secchi

Elena Secchi

Technical Sales Representative | Associates of Cape Cod, Inc.

Michele Simone

Michele Simone

Corporate Quality Director | Bracco Group, PDA Regulatory Affairs and Quality Assurance Board (RAQAB) member

Satyakam Singh

Satyakam Singh

Director, Head of Cell Therapy Process and Analytical Development | Simnova Biotechnology

Matthew Stevenson

Matthew Stevenson

European Sales Manager | Associates of Cape Cod, Inc.

Andrea Tanzini

Andrea Tanzini

Local Head of Business – Pharma & Medical – Italy | Staubli Robotics

Filippo Trionfera

Filippo Trionfera

Quality Operation Manager & Qualified Person | BSP Pharmaceuticals, PDA Italy Chapter

Veronika S. Wills

Veronika S. Wills

Associate Director, Global Technical Services | Associates of Cape Cod, Inc.

Maria Paola Baini

Maria Paola Baini

Associate Director, Quality-Strategic Growth Investment & Engineering | Lonza

Orazio Cultrera

Orazio Cultrera

Pharmaceutical Industries Consultant | Cultrera Consulting, Steering Committee PDA Italy Chapter

SPONSORS 2024 IN PROGRESS

Copan

Gold Sponsor
Copan

Rapid Micro Biosystems

Gold Sponsor
Rapid Micro Biosystems

BioItalia

Silver Sponsor
BioItalia

Veltek

Exhibitor
Veltek

Mesa Labs

Exhibitor
Mesa Labs

RIGEL

Exhibitor
RIGEL

Vileda

Exhibitor
Vileda

Rapid Microbiology

Media Partner
Rapid Microbiology

Become a 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!

Conference Venue

The Pharma Microbiology Congress 2024 will be a mixed event:

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.

All the past editions

Download brochures from previous editions of Pharma Microbiology Congress 2024

Sign up for the conference

Face to Face (8/11/24)
Early bird until 28/09/2024*

450€
500€

Virtual (28-29/10/24)
Early bird until 28/09/2024*

750€
800€

Virtual + Face to Face (28-29/10/24 e 8/11/24)
Early bird until 28/09/2024*

1100€
1200€

* Hospitals, Universities and freelancers get a 40% discount on published prices (discounts cannot be combined).

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