HPAPI Handling & Manufacturing Summit 2021

September 29^th – September 30^th2021

VIRTUAL CONFERENCE

CONFERENCE OVERVIEW

CONFERENCE OVERVIEW

Highly potent active pharmaceutical ingredients (HPAPIs) are known as powerful compounds that might help to treat severe and life-threatening conditions and diseases. At the same time, due to their high potency, these compounds have potential risks for the personnel in the production facility. Special precautions need to be taken to ensure the safety of operators and on the other hand high product quality is also required.

At our online meeting industry leaders, occupational toxicologists and containment experts will present the latest insights affecting the HPAPIs handling landscape. We will talk about complex highly potent compound projects focusing on safe and robust potent API processing, development and scale-up of processes, occupational health risks and toxicological assessment, advancements in isolators and facilities to minimize exposure risk, containment strategies and management of cross-contamination risks and more.

Inevitably, safe and efficient HPAPI handling requires a careful evaluation of multiple factors. Explore how pioneering pharma companies are approaching HPAPI development and processing this coming September.

WE WILL TALK ABOUT

WE WILL TALK ABOUT

classification and handling of hazards, PDE/OEL/HBEL setting in HPAPI environment
occupational health, exposure monitoring and analysis of industrial hygiene data
process development, scale up and production of complex highly potent compounds
developing HPAPI containment strategy, containment verification and monitoring
latest advancements in isolators and facility designs to minimize the risk of exposure
highly potent APIs in cleaning validation programs, risk-based cleaning validation
regulatory & quality framework for contamination control and safe handling of HPAPI
CMO evaluation and selection, supply chain management in CMO partnerships

WHO IS IT FOR?

WHO IS IT FOR?

CxO, VP, Directors, Heads, Managers of

HPAPI Manufacturing/ API Manufacturing/ Compounds Manufacturing
Occupational Toxicology/ Industrial Hygiene / EHS
Process Engineering/ Process Development/ Process Scale Up
Containment/ Cross Contamination/ Cleaning Validation
Cleanroom/ Facility Design/ Isolators
Risk Management/ Quality Assurance/ Quality Control
Analytical Development/ Analytical Methods
CMO/ CDMO/ Outsourcing

Our Sponsors

BECOME A SPONSOR

SPEAKER SPONSOR

Speaking Companies

Speaker Board

BECOME A SPEAKER

Martin Kohan

Managing Toxicologist

SafeBridge Europe

Mariann Neverovitch

Research Scientist

Bristol-Myers Squibb

Stefano Butti

Head of Sales Group

F.P.S. Food and Pharma Systems

Claudia Sehner

Senior Toxicologist

Boehringer Ingelheim Pharma GmbH

Ildikó Ziegler

QA Manager

Vanessa Research

Martin Axon

Senior Principal Occupational Hygienist

SafeBridge Europe

Vincenzo De Sio

HPAPI Manufacturing Manager

Cristália Prod. Quim. e Farm. LTDA

Justin Mason-Home

Director

HPAPI Project Services Limited

Rich Arnett

Manager, Industrial Hygiene & Toxicology

Pharmascience Inc.

Fred Ohsiek

Sr Specialist, Cleaning Validation

Novo Nordisk

Jack Brown

Consultant

Scale up Solutions; LLC

Thomas Adam

Head of GQA Chemical APIs

Bayer AG

[Agenda] HPAPI Handling & Manufacturing Summit 2021

Download the full summit program to find speaker biographies, case studies, key takeaways, the day’s schedule, and details of each session.

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ATTENDEES IN 2021

ATTENDEES IN 2021

● A/S Grindeks ● Abdi Ibrahim Global Pharm ● AdhexPharma ● AGC Pharma Chemicals Europe, S.L.U. ● Apotex Inc. ● AstraZeneca ● Aurobindo Pharma Limited ● Bayer AG ● BioDuro-Sundia Corporation ● Biotage GB Ltd ● Biovac ● Boehringer Ingelheim ● Boehringer Ingelheim Pharma GmbH & Co. KG ● Bristol-Myers Squibb ● Cambrex Corporation ● Catalent ● Cipla Ltd. ● Cristália Prod. Quim. e Farm. LTDA ● Custom Pharma Services ● Eurofins Amatsigroup ● FAREVA Mirabel ● Farmabios SPA ● FPS Food and Pharma Systems srl ● Fresenius Kabi ● Gedeon Richter Plc. ● Glatt India Engineering Pvt Ltd ● HPAPI Project Services Limited ● Johnson&Johnson ● Kindeva Drug Delivery ● Labesfal-Laboratórios Almiro S. A. ● Merck KGaA ● MSD Ballydine ● Novo Nordisk ● Nuvisan Pharma Services ● Oakwood Laboratories, LLC. ● Olon S.p.A ● Oncomed Manufacturing a.s. ● Organon Pharma BV ● Pharmascience Inc. ● Pharmascience Inc. ● PharmaZell GmbH ● Polpharma SA ● Quay Pharmaceuticals ● RCPE GmbH ● SafeBridge Europe ● Sai Life Sciences Limited ● Sandoz GmbH ● Saneca Pharmaceuticals a.s. ● Sanofi ● Sanofi Chimie ● Sanofi-Aventis ZRT ● Scale up Solutions ● Siegfried Evionnaz SA ● STADA Arzneimittel AG ● Symeres ● Vanessa Research