Mittwoch, 20. Februar 2019, RIU PLAZA Berlin, Highly Potent APIs Summit 2019

Von 20. Februar 2019 - 8:00
Bis 21. Februar 2019 - 19:00

RIU PLAZA Berlin

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Our website: Highly Potent APIs Summit 2019
We are honoured invite you to participate at the Highly Potent APIs Summit 2019, happening in 20-21 February, 2019.
Venue: Hotel RIU PLAZA Berlin, Martin-Luther-Straße 1, 10777 Berlin, Germany.
Joining companies: Lonza AG, ILC Dover, Bristol Myers Squibb, De Montfort University, HPAPI Project Services Limited, MSD International, Leeds Beckett University, Novartis, Regeneron Pharmaceuticals, Inc, Gedeon Richter, Teva Pharmaceuticals, Patheon, part of Thermo Fisher Scientific, Bayer AG, Skan AG, ChargePoint Technology Ltd, Praevena AG, Affygility Solutions, Biocon, Pliva Croatia Ltd, Piramal Pharma Solutions, MSD, Lonza have all confirmed their participation.
 
CONFERENCE OVERVIEW:
The increasing incidence of cancer and the ever-rising demand for anticancer drugs results in significant growth for the highly potent active pharmaceutical ingredients (HPAPIs) market. The highly toxic properties of HPAPIs, however, present manufacturing and handling challenges.
Our meeting facilitates hands-on experience sharing with focus on early process development and scale up, occupational health regulations and safety standards, cross-contamination risk assessment and control, aseptic facilities and equipment maintenance and cleaning, outsourcing and technology transfer strategies.
 
SPONSORS

Silver - ILC Dover
Bronze - Hebeler Process Solutions, LLC - Buflovak & PK
Speaking - Lonza AG


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SPEAKERS BOARD:

Ester Lovsin Barle, PhD, MScTox, ERT | Head Corporate Toxicology | Lonza AG, CH
Scott Patterson | Vice President Commercial Sales | ILC Dover, USA
Mariann Neverovitch | Research Scientist | Bristol Myers Squibb, USA
Prof. Geoff Smith | Professor of Pharmaceutical Process Analytical Technology | De Montfort University, UK
Jeremy Justin Mason-Home, BSc (Hons), FRSC | Director | HPAPI Project Services Limited, UK
Tim Briggs, MA CFIOSH | Course Director Health Safety and Environmental Management | Leeds Beckett University, UK
Anthony Cannon | Regional Director, ExM, Global Tech Ops, Sterile | MSD International, CH
Andreas Schreiner | Director of Validation, Manufacturing Science and Technology | Novartis, CH
Orla McGarvey | Principal Group Leader, Drug Product Process Development | Lonza AG, CH
Toral Mehta,CIH, CSP | Head Industrial Hygiene and Containment, Health, Safety, Environment | Novartis, AT
Michael B. Whaley | VP Global EHS | Ipsen, USA
Dr. Thomas Nittoli, PhD | Director, R&D Chemistry Therapeutic Proteins | Regeneron Pharmaceuticals, Inc, USA
Dr. Ildiko Ziegler | Distinguished validation expert | Gedeon Richter, HU
Enrico Bettetini | R&D Technology & Pilot Manager | Teva Pharmaceuticals, IT
Anil Kane, Ph.D., MBA | Executive Director, Global Head of Technical & Scientific Affairs Pharma Services | Patheon, part of Thermo Fisher Scientific, CA
Michel Crevoisier | Consultant | Formerly Novartis Senior QA and GMP Expert, CH
Kees Hommes | Global Occupational Hygiene and Safety Manager | Bayer AG, DE
Richard Denk | Head of Sales Containment | Skan AG, CH
Michael Avraam | Global Product Manager for ChargePoint PharmaSafe | ChargePoint Technology Ltd, UK
Silke Buechl | Deputy Managing Director, Occupational Hygienist | Praevena AG, CH
Dean Calhoun, CIH | President/CEO | Affygility Solutions, USA

 
CONFERENCE PROGRAMME:
 
Day 1st | Wednesday, 20 February 2019
 
07:30 - Registration and Welcome Coffee
08:15 - Opening Address from the Chairman
PART #1: REGULATORY LANDSCAPE
08:25 - GMP and Occupational Safety Requirements for highly potent aseptic processing.

How does GMP and Occupational Safety fit together?
What are Cross Contamination requirements in shared facilities?
Cleaning requirements and limits for non-product contact surfaces

Richard Denk Head of Sales Containment - Skan AG, CH
09:00 - Speed ​​Networking
PART #2: PROCESS ROBUSTNESS, SAFETY & EFFICIENCY
09:40 - Practical Delivery of HPAPI Projects.

Demystifying potent compound project elements
Connecting hazard and control via risk assessment
Facility and equipment design – getting the big stuff right
Understanding and managing uncertainty
Practical steps for protecting workers and products

Jeremy Justin Mason-Home, BSc (Hons), FRSC Director - HPAPI Project Services Limited, UK
10:15 - An Ipsen Case Study in Potent Compound Handling.

This session will describe the efforts undertaken by Ipsen to plan, design, implement and manage a highly potent compound employed in product manufacturing.

Michael B. Whaley VP Global EHS - Ipsen, USA
10:50 - Morning coffee and networking break
11:20 - Risk-based handling of highly potent APIs: cross-contamination and transportation parameters.

Guidelines regarding Quality Risk Management
Case study 1: technical aspects and complexity in cross contamination risk analysis
Case study 2: temperature deviation during transportation

Dr. Ildiko Ziegler Distinguished validation expert - Gedeon Richter, HU
11:55 - Giving Employees Their Voice Leads to Better Risk Assessment.
Risk assessment is a statutory process that has many benefits. Research shows that involving employees in job based risk assessment has many benefits for any business, not least leading to improved organisational and employee knowledge. In todays brain based economy can organisations afford not to develop the knowledge of their employees?
This session highlights the unseen benefits of listening and involving your employees.
Tim Briggs MA CFIOSH Course Director Health Safety and Environmental Management Courses, Past President IOSH - Leeds Beckett University, UK
12:30 - Single Use Flexible Isolators reduces cleaning and cross contamination risk.

Introduction of single use flexible isolators and containment performance Ergonomic benefits when using flexible isolators and other single use technology Disposal of the single use vs. cleaning - risk reduction Disposal of the single use vs. cleaning - cost reduction.
Using a single use flexible isolator provides cost savings and reduces risk of cross contamination from retention. This is very important with HPAPI and cleaning limits being reduced

Scott Patterson Vice President Commercial Sales - ILC Dover, USA
13:05 - Business lunch
14:05 - SESSION RESERVED.
To Be Announced
14:40 - Novel Antibody Drug Conjugate Manufacturing - Synthesis, Conjugation, and Coordination.

Synthesis and conjugation:

Technology transfer
Scale-up
Qualification
ADC Toxicology lot
ADC GMP lot



Dr. Thomas Nittoli, PhD Director, R&D Chemistry Therapeutic Proteins - Regeneron Pharmaceuticals, Inc., USA
PART #3: CLEANING VALIDATION
15:15 - Cleaning Validation as one driver to prevent cross-contamination.

Introduction to health based exposure limits
Regulatory requirements and audit experience
Case study

Andreas Schreiner Director of Validation, Manufacturing Science and Technology - Novartis, CH
15:50 - Afternoon coffee and networking break
16:20 - Cleaning Validation for API: Reaching a Steady State.

Understanding Cleaning Validation as Process Validation
Using HBEL for a cleaning risk assessment
Setting a single residue limit for all the equipment
How to focus cleaning validation activities on high risk situations

Michel Crevoisier Consultant - Formerly Novartis Senior QA and GMP Expert, CH
16:55 - Analytical Approach for Implementation of Visual Inspection.
Visual inspection following equipment cleaning is a mandatory step in the cleaning verification workflow for pharmaceutical equipment. Equipment must pass visual inspection before swab sampling for analysis can be performed. However, since a significant number of low risk compounds are visible well below established safety levels, it is possible to justify equipment as “visually clean” without performing swabbing analysis. Internal studies performed at BMS showed that over 90% of participants could identify residual product at a level of ~2 ppm without preliminary training. The implementation of a robust visual inspection qualification program and clear “Visually Clean” inspection parameters can enable visual inspection to be used to qualify equipment in lieu of swab analysis for low risk products.
Mariann Neverovitch Research Scientist - Bristol Myers Squibb, USA
17:30 - Roundtable Discussions
18:00 - Chairman's closing remarks and end of day one
19:00 - Business dinner
 
Day 2nd | Thursday, 21 February 2019
08:00 - Registration and Welcome Coffee
08:40 - Opening Address from the Chairman
PART #4: OCCUPATIONAL TOXICOLOGY & INDUSTRIAL HYGIENE
08:50 - WORKSHOP - How to identify high potency and high toxicity and what to do with it.

Data mining: Key information that determines toxicity and potency
Data interpretation: What should you ask yourself to interpret toxicity and potency correctly
Limit setting: How to set Health Based Exposure Limit
Using the limit: How to use the OEL and PDE in the risk assessments

Ester Lovsin Barle, PhD, MScTox, ERT Head Corporate Toxicology - Lonza AG, CH
09:50 - Exposure Monitoring at the workplace - challenges due to workplaces and the new EN689.

Defining monitoring strategy for exposure monitoring
Exposure monitoring from planning to execution
Challenges during exposure Monitoring in the daily life
Changes in exposure Monitoring due to EN689

Silke Buechl Deputy Managing Director, Occupational hygienist - Praevena AG, CH
10:25 - Morning coffee and networking break
10:55 - Understand, evaluate and mitigate Risks of occupational Exposures .

Explore classic occupational hygiene approach vs. innovative risk evaluation approach
Hazard based approach vs. risk based approach
PPE dependency vs. containment dependency
Over engineering vs. adequate containment

Toral Mehta CIH, CSP, Head Industrial Hygiene and Containment - Novartis, AT
11:30 - Chemical Exposure Assessment and Control; the Bayer HPAPI approach.

Occupational Health & Safety Risk Assessment
Exposure Modelling & Monitoring
Controlling exposures to HPAPI’s
Validation of a banding approach

Kees Hommes Global Occupational Hygiene and Safety Manager - Bayer AG, DE
PART #5: FACILITY DESIGN, CONTAINMENT TECHNOLOGIES & PROCESS EQUIPMENT
12:05 - SESSION - RESERVED.
To Be Announced
12:40 - Business lunch
13:40 - Analysis of containment testing.

Growth in HPAPI processing and how containment requirements are being influenced
Analysis of SMEPAC assessments – the general requirements and the irregularities in how tests are performed
Interpretation of results and comparing like for like
Review of swab analysis
Laboratory testing vs real world

Michael Avraam Global Product Manager for ChargePoint PharmaSafe - ChargePoint Technology Ltd, UK
14:15 - Top ten audit findings from HPAPI facilities.
In order to have an effective potent compound safety program, auditing must be performed on a periodic basis. In this session, Dean Calhoun will share the top ten audit findings based decades of professional auditing experience throughout the world.
Dean Calhoun CEO - Affygility Solutions, USA
PART #6: CMO STRATEGIES & OUTSOURCING
14:50 - SESSION - RESERVED.
To Be Announced
15:25 - Afternoon coffee and networking break
15:55 - Development & Manufacturing Considerations of High Potent Drug Products – a CDMO’s perspective.

Trends of High Potent API’s and a CDMO view on the future of supporting high potent drug product manufacturing
Regulatory considerations in handling special category of compounds in a segregated infrastructure
Case studies and containment solutions in handling potent API’s in drug product manufacturing
CDMO view on strategizing supporting high potent API and DP manufacturing support to the pharmaceutical industry

Anil Kane, Ph.D., MBA Executive Director, Global Head of Technical & Scientific Affairs Pharma Services - Patheon, part of Thermo Fisher Scientific, CA
16:20 - OUTSOURCING 4.0: Pharma towards the innovative CMOs network.

New frontiers: sterile respiratory and modified-release drugs
Research & developing of CMOs
Relationships & Quality without compromise
Assessing results at production scale

Enrico Bettetini R&D Technology & Pilot Manager - Teva Pharmaceuticals, IT
16:55 - Roundtable Discussions
17:25 - Chairman's closing remarks and end of summit
 
CANCELLATION & SUBSTITUTION POLICY:
You may substitute a delegate at any time and at no extra cost.
Cancellations must be in a written notice.
Cancellations made 14 days or more before the event start date will be refunded less than 50% of the registration fee.
Cancellations made less than 14 days before the event start date will receive no refund. If you cannot attend an event due to illness or other unforeseen circumstances, you may transfer your delegate pass to another upcoming event within one year from original event start date.

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