HIGHLY POTENT ACTIVE PHARMACEUTICAL INGREDIENTS VIRTUAL SUMMIT 2021

SEPTEMBER 22-23, 2021

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Hour(s)

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Demand for HPAPIs keeps rising, so does the need for expanded manufacturing capabilities and appropriate safety procedures
and equipment to protect personnel and sites from the challenges highly potent compounds could bring.

Days

Speakers

Companies

This conference will cover wide spectrum of topics: from current and upcoming market conditions, improving quality risk management, current and emerging technologies for HPAPI manufacturing and containment, stepwise risk assessment of HPAPI projects, effective management of contamination risks to new modular manufacturing facility, automation and robotics, advancing partnerships in outsourcing, sustainability and digitalisation in HPAPI.

Key Points

  • Digitalisation in HPAPI
  • Containment Expertise
  • Effective Outsourcing and CMO Industry
  • Validation methods
  • Cleaning and Waste Management

  • Inhaled HPAPIs

  • Scale-Up Challenges

  • EHS

  • Cross-Contamination
  • Sustainable Production
  • Automation and Robots
  • Isolator design

Industries

Pharmaceutical

Biotechnology

Chemical

CMOs/CDMOs

Handling & Containment Services

Equipment Suppliers

Job Titles

  • C-LEVEL/PRESIDENT 3% 3%
  • VP/DIRECTOR 53% 53%
  • HEAD OF DEPT 14% 14%
  • CONSULTANTS 13% 13%
  • SENIOR MANAGERS 17% 17%

ADC
API and HPAPI
Aseptic Processing Cleanrooms
CMC
Compounds Manufacturing Containment
Contamination
Drug Safety Evaluation Environmental
Equipment Selection
Facility design
Formulation Development Hazard Assessments
Health & Safety
Industrial Hygiene
Isolation

Laboratory Services Occupational Health
Officers Occupational
Toxicology Outsourcing
Plant & Site Management Plant Management
Process Development
Process Engineering
QC & QA
Regulatory
Research & Development
Risk Assessment, Evaluation & Mitigation
Scale-up Operations Scientists
Toxicology
Validation

Speakers

Dr. Martin Kohan

Senior Occupational Toxicologist
AstraZeneca

Brian Schmidt

Global Head Occupational Hygiene
Takeda

Dr. Ildiko Ziegler

Quality Assurance Manager
Vanessa Research

Georgi Dimchov

EHS&S Director
Teva Pharmaceuticals

Dr. Thomas Adam

Head of QA Chemical
Bayer

David Eherts

Vice President
Allergan

Jay Brown

Director of EHS
Mayne Pharma

Toral Mehta

Industrial Hygienist And Containment Expert
MSD

Request Official Agenda
to see the last updated program

Schedule

Day 1 – Wednesday Sep, 22

10:45 – 11:00 CET

Opening Statements

Event Coordinator

11:00 – 11:30 CET

Identifying HPAPIs
– How much is too much?

Details
  • Understanding Toxicity & Potency to identify HPAPIs
  • Health-Based Exposure Limits (HBELs)
    – How are HBELs established?
    – Why we need HBELs?
  • Case study – A good quality PDE

Dr. Martin Kohan
Senior Occupational Toxicologist
AstraZeneca

11:35 – 12:05 CET

How to handle HPAPIs in chemical
Development (Case Studies)

Details
  • GMP-Compliance and Regulatory Environment
  • Cleaning of Equipment in the Manufacturing of HPAIs
  • Prevention of Cross-Contamination in Shared Facilities

Dr. Thomas Adam
Head of QA Chemical APIs
Bayer

12:05 – 12:35 CET

Networking & Refreshment Break

12:35 – 13:05 CET

Digitalisation in HPAPI

Details
  • Accelerate Improvements in HPAPI
    Production
  • Digital Modelling and Simulation
  • Process Analytical Technology (PAT)
  • Automated Visual Assessment VR And AR
  • Machine Learning and Data Analysis

Senior Representative

13:10 – 13:40 CET

Using the Advanced Reach Tool to enhance Control Banding for the Pharmaceutical Industry

Details

Control banding has been established in the Pharma industry for decades to help determine required engineering controls or containment. Such systems have several drawbacks e.g. overemphasis on hazard compared to exposure risk. Utilizing the modeling engine of the Advanced Reach Tool provides an alternative to identify risk-appropriate exposure control strategies.

Brian Schmidt
Global Head Occupational Hygiene
Takeda

13:45 – 14:15 CET

Global Containment Expertise for HPAPI

Details
  • Designing Single Use Systems
  • How to correctly assess, plan and implement the most cost-effective containment
  • Case Study

Senior Representative

14:15 – 15:30 CET

Networking & Lunch Break

15:30 – 16:00 CET

Best Approaches for Containment HPAPI Handling Processing Strategy

Details
  • Standards for Engineering Controls
  • Equipment and Technology Selection
  • Case Study

Senior Representative

16:05 – 16:35 CET

Environmental Risk Assessment

Details
  • Hazard Assessment in a HPAPI
    Environment
  • Deriving Performance Data for Risk
    Assessments
  • Maintenance Plan to Safeguard the
  • Reliability of the Containment Solution
  • Case Study

Senior Representative

16:35 – 17:05 CET

Networking & Refreshment Break

17:05 – 17:35 CET

Industrial Hygiene Monitoring and Validation of Engineering Controls Effectiveness

Details
  • Industrial Hygiene Monitoring
  • Containment process equipment
  • Administraive measures to reduce operator exposure

Georgi Dimchov
EHS&S Director
Teva Pharmaceuticals

17:40 – 17:50 CET

End of Day One – Closing word from the Chair

Day 2 – Thursday Sep, 23

10:45 – 11:00 CET

Chairperson’s Opening Remarks

11:00 – 11:30 CET

Assessing the manufacturing of different semi-solids in the light of cross contamination risk

Details
  • Guidelines regarding cross contamination and toxicological approach
  • Complexity in risk analysis of cross contamination and some possible measures
  • Case study: ointments for different uses

Dr. Ildiko Ziegler
Quality Assurance Manager
Vanessa Research

11:35 – 12:05 CET

Inhaled HPAPIs

Details
  • Equipment and Analytical Tools that are Most Suitable for Respiratory Containment and Safe Handling
  • Current Trends and Developments

Senior Representative

12:05 – 12:35 CET

Networking & Refreshment Break

12:35 – 13:05 CET

Sustainable Production of Highly Potent APIs (HPAPIs)

Details
  • Specific Precautions for Operator Health and Safety
  • Maintaining Product Quality

Senior Representative

13:10 – 13:40 CET

Next Steps in Pharmaceutical
Manufacturing: Automation and Robots

Details
  • Potential for Automating Production Processes
  • Robotic Assistance to Limit Exposure to Hazardous Substances and Protect Operators
  • Equipment Capable of Integration and Interoperability with Other Equipment in the Supply Chain

Senior Representative

13:45 – 14:15 CET

Isolator Design for Operator Safety

Details
  • Different Technologies
  • Case Studies on Realized Customer
    Projects
  • Summary and Outlook

Senior Representative

14:15 – 15:30 CET

Networking & Lunch Break

15:30 – 16:00 CET

New Techniques for Cleaning and Waste Management

Details
  • Training and Managing Workers with HPAPI Exposure
  • Reduce Waste from Personal Protective Equipment
  • Case Study

Senior Representative

16:05 – 16:35 CET

Operational effectiveness in an HPAPI world – balancing the risks of cross-contamination, occupational exposure, cost, and practicality – there is no ‘one size fits all’ approach

Details
  • Identifying the ‘must haves’ vs the ‘nice to haves’
  • Ensuring safety and acceptable risk without ‘over-engineering’
  • Leveraging HBEL’s to achieve the required standard

Senior Representative

16:35 – 17:05 CET

Networking & Refreshment Break

17:05 – 17:35 CET

Challenges in how EHS should be integrated with product development for maximum business impact

Details
  • Identification and Evaluation of All
    Potential Risks, Definitions and Continuous Review the Levels of Acceptance
  • Cleanroom Requirements to Reflect GMP
  • Standards & EHS
  • Control at the design and planning stage is key

Senior Representative

17:40 – 18:10 CET

Panel Discussion: TBA

 

18:15 – 18:20 CET

End of Day Two – Closing word from the Chair

For Sponsors

Virtually meeting with key decision makers and qualified buyers during our exclusive conference with a great return on your investment. We offer a selection of sponsorship options that will increase the opportunity to develop new relationships during our events. Our sponsorship team can work with you to create an innovative sponsorship package tailored to the exact needs of you and your company which will suit your budget while maximizing your value.

Want to see our sponsorship packages?
Please contact info@virtual-summit.eu for more information.

Certificate of Attendance

Each delegate will receive a Digital Certificate of Attendace
with option to get printed version of certificate.

Registration

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