September 28th – September 29th 2023
Highly potent active pharmaceutical ingredients, or HPAPIs, are potent compounds that could effectively treat serious and life-threatening diseases such as cancer. Because of their high potency, these substances eventually put the workers in the production facility at risk. While exceptional product quality is required, additional measures must be taken to ensure operator safety.
At our online meeting, leading figures from the industry, occupational toxicologists and containment specialists will review the most recent developments affecting the handling of HPAPIs. The discussion will center on the safe and effective processing of potent APIs, process development and scale-up, occupational health hazards, toxicological assessment, improvements in isolators and facilities to minimize exposure risk, containment and cleaning validation practices, and risk management for cross-contamination.
In the end, managing HPAPI safely and effectively necessitates a thorough evaluation of a number of factors. This September, keep a look out for any new developments in HPAPI production and processing.
WE WILL TALK ABOUT
- PDE/OEL/HBEL settings in HPAPI context, hazard classification and monitoring
- exposure monitoring and occupational health, industrial hygiene data analysis
- process development, scalability and manufacturing of high-potent compounds
- developing HPAPI containment plan, verifying and monitoring containment
- the newest developments in isolators and facility designs to reduce exposure risk
- cleaning validation processes and risk-based cleaning validation in highly potent APIs
- quality and regulatory framework for safely managing HPAPIs
- CMO selection and evaluation, supply chain management and CMO partnerships
WHO IS IT FOR?
CxO, VPs, 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
WHO ATTENDED THE EVENT IN 2022
● LaboratóRio Edol – Produtos FarmacêUticos S.A. ● Hameln Rds S.R.O. ● HAS Healthcare Advanced Synthesis SA ● Research Center Pharmaceutical Engineering GmbH ● Esteve Quimica, S.A. ● Sterling Pharma Solutions Ltd ● Douglas Pharmaceuticals Ltd ● Sanofi ● Wildlife Pharmaceuticals (Pty) Ltd ● Merck KGaA ● Toxiconsultant S.L ● Gedeon Richter Plc. ● Shaoxing Hantai Pharmaceutical Co., Ltd. ● Lamda Laboratories SA ● Hellenic Breweries Of Atalanti S.A. ● Maprimed S.A. ● Glatt Pharmaceutical Services GmbH ● SEQENS ● SANOFİ ILAC SAN. TIC. A.Ş. ● Evotec ● Sanovel Pharmaceutical ● Teva Pharmaceuticals Inc ● PharmaLex India Pvt. Ltd. ● Pharmascience Inc. ● Dr Abidi Pharmaceutical ● EUROAPI ● Ferring Pharmaceuticals ● Angelini Pharma ● Hammersmtih Medicines Research ● Cehtra ● Delpharm Reims ● Recordati S.P.A. ● Delpharm Poznan ●HPAPI Project Services Limited ● Halozyme ● Scale Up Solutions; LLC ● SafeBridge Europe ● Lonza ● BSP Pharmaceuticals S.P.A. ● CPCI™ ● Piramal Pharma Solutions
WHO ATTENDED THE EVENT 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