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overview

SMi is delighted to announce its 5th Annual Highly Potent Active Pharmaceutical Ingredients virtual conference on the 10th-11th May 2021.


The Global High Potency API/HPAPI Market is projected to reach 37 billion USD by 2027, growing at an ever-increasing CAGR of 8.43%. The expanding production of high potency APIs, along with the increase in associated toxicities, are driving requirements for more effective containment solutions and much-needed guidelines to ensure worker safety. The conference will encompass hot topics including: robotics and automation for containment solutions, strategies for scaling-up, successful prevention of cross-contamination, and industry examples in cleaning validation.


This year’s event will focus on 4 key themes: best practices for toxicological assessment, innovations in facility design automation, effective containment and cross-contamination prevention, and industry approaches to cleaning validation. Key case studies will be highlighted throughout these themes, revealing the key challenges for current HPAPI manufacture, and insights into the latest technological and regulatory advances in this increasingly potent environment.
 

This two-day agenda offers you peer-to-peer networking with industry experts including heads and directors of EHS, Occupational Hygiene, Quality Assurance and more. Expand your community and explore the latest developments in the industry at this two-day event, including key regulatory updates, and leading case studies from leading pharmaceutical and biotechnology companies.

  • EXPLORE best practices in hazard assessment and occupational toxicology
  • DISCUSS future trends in technologies for protecting operators from hazardous substances
  • DISCOVER emerging possibilities for automation and robotics in pharmaceutical manufacture
  • DELVE into leading case studies on cleaning validation and visual inspection
  • UNDERSTAND strategic considerations for planning pilot plants and scaling up manufacturing capabilities for high potency compounds 
  •  

 

 The SMi Virtual Conference Platform will deliver the following benefits:

  • Live and On Demand speaker content: Get access to the latest strategies and case studies from your market place online!
  • Network with all the event attendees: Connect, see who’s attending, chat and share contact details with all online delegates, speakers and sponsors
  • Exhibit a Virtual Booth: You can pack your customized booth full of documents, videos and even show who is manning the booth during the event and hosting meetings
  • Host & Join Meetings & Socials: Join preferred speaking sessions, host you own meetings and even a virtual Networking social, with in built Zoom functionality

 

Key job titles include:

  • Head of Occupational hygiene
  • Head of Industrial hygiene
  • Head of Containment
  • Head of Corporate Toxicology
  • Head of Validation
  • Director of Operation Quality
  • Director of EHS
  • Director of Drug Safety Evaluation
  • Industrial Engineer
  • Validation Expert
  • Manufacturing Specialist
  • QA Specialist/Manager
  • Scale-up Operations Manager

AstraZeneca; Bayer AG; BSP Pharmaceuticals S.p.A.; CIEHF; Corporate Health Ireland ; Dec Group; DSTL; GSK; Heriot-Watt University; HPAPI Project Services Limited; Human Reliability Ltd; Lonza; Pharmadagio Limited; SKAN AG; Teva Api Div;

Conference programme

9:00 Chair's Opening Remarks

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Project Services Limited
View Bio

9:10 PPE in COVID-19 vs Engineering Controls in Pharma

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Project Services Limited
View Bio

• SARS-Cov-2 and Potent APIs - Similarities and Differences
• Can pharma engineering controls be used to protect healthcare workers during COVID-19?
• ‘PPE’ perspectives in COVID-19 compared to PPE in pharma
• Governments, Regulators, Expert Bodies and others, will we be prepared for next time?
 

9:50 HPAPI – the dose makes the poison

Ester Lovsin-Barle

Ester Lovsin-Barle, Head Product Stewardship and Health, Takeda Pharmaceutical Company Limited
View Bio

• What is HPAPI
• What are Health Based Exposure Limits (HBELs)
• Regulatory application of HBELs in HPAPI manufacturing
 

10:30 Morning Break and Virtual Exhibit Hall Open

11:00 Process equipment design for HPAPI containment system integration

Stefano Butti

Stefano Butti, Head of Sales Group, F.P.S. Food and Pharma Systems Srl
View Bio

• Are all standard Process Equipment suitable to safe handle HPAPI?
• Process Equipment critical analysis for high containment system integration
• Case studies
• Conclusions and new challenges
 

11:40 Risk assessments of impurities in potent drug substances (APIs)

Raphael Nudelman

Raphael Nudelman, Director of Chemical and Computational Toxicology, Teva Pharmaceuticals Industries
View Bio

• An introduction into mutagenic impurities
• Toxicological qualification of impurities in potent APIs
• Regulatory requirements and considerations
• Available guidelines and advice for toxicological assessments
 

12:20 Hazard identification and assessment in a HPAPI environment

Olindo  Lazzaro

Olindo Lazzaro, Director, Global EHS Technical Operations, AbbVie
View Bio

• Identifying potential routes of exposure to highly potent APIs
• OH exposure risk assessment and improvement projects
• PIE – Manufacturing Effluent Management
• Translating hazard assessments into appropriate engineering controls
• Strategies for effective containment improvement
 

13:00 Networking Break and Virtual Exhibit Hall Open

14:00 Containment Verification Testing for Pharmaceutical Equipment Performance

George Petroka

George Petroka, Principal, Director BioPharma/EHS Services , IES Engineers
View Bio

• Overview of ISPE Guide - Assessing the Particulate Containment Performance of Pharmaceutical Equipment (APCPPE)
• Applying the APCPPE Guide to various pharmaceutical equipment and containment systems
• Several Case Studies
 

14:40 Turning auditing on its head

Doreen Parrish

Doreen Parrish, Head of Corporate EHS Audit, Takeda Pharmaceutical Company Limited
View Bio

• Introduction to T’DA auditing
• Why do we audit?
• Back to basics
- Set clear objectives and expectations
- Become part of your companies’ brand; integrate with business
- Focus on priorities
- Audit is not the end all be all
• Quick word on VirMote (Virtual / Remote) Auditing
• Auditing Skills Development – Ready to have some fun?
 

15:20 A strategy in high potent compounds EHS and quality aspects

Reinhold Maeck

Reinhold Maeck, Head of Corporation EH&S Regulatory Intelligence, Boehringer Ingelheim Pharmaceuticals Incorporated

15:50 Afternoon Break and Virtual Exhibit Hall Open

16:30 Automation and robotics shaping the future of pharmaceutical manufacture

Richard Denk

Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
View Bio

• Opportunities for automating manufacturing processes and controlling processing safely
• Innovations in robotic technologies to limit interactions with hazardous substances and protect operators
• Machinery capable of integration and collaboration with other equipment in the supply chain
• Predictions towards the future of HPAPI manufacture
 

17:10 Design of high potent plants

Timo Rosvall

Timo Rosvall, Senior Containment Engineer, TKR Teknik
View Bio

• Small-scale high potent plants
• Upgrade dispensing from PPE to Glove bags
• Containment with Big bags in API plants
 

17:50 Chair’s Closing Remarks and Close of Day One

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Project Services Limited
View Bio

9:00 Chair's Opening Remarks

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Project Services Limited
View Bio

9:10 Assessing cross contamination risk in an ointment plant – a case study

Ildiko Ziegler

Ildiko Ziegler, QA Manager, Vanessa Research
View Bio

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

9:50 Path to HPAPI analytical laboratory to respirator free!

Toral Mehta

Toral Mehta, SME, Industrial Hygiene, Global EHS, MSD Animal Health

• Upgrade of the laboratory facilities and containments
• Control at the design and planning stage is key
• Critical role IH/EHS plays in Project Team
• Risk based decision and communication
 

10:30 Morning Break and Virtual Exhibit Hall Open

11:00 Calculation of Health-Based Exposure Limits - The Importance of a Qualified Expert

Martin Kohan

Martin Kohan, Senior Occupational Toxicologist, AstraZeneca
View Bio

• A Qualified Expert: The Right Person for the Job
       - Industry and Regulatory Expectations
       - Profile
• Lack of Adequate Expertise
       - What Can Go Wrong?: Examples
       - Implications
 

11:40 Introduction of biologics with high potency into shared facilities

Florian Grundmann

Florian Grundmann, MSAT Team Leader Cleaning Validation, Roche
View Bio

• Cleaning validation principles
• Protein inactivation
• ADC challenges
 

12:20 Networking Break and Virtual Exhibit Hall Open

13:20 Session Reserved for Catalent

14:00 Approaches to cleaning validation for potent APIs

Fred Ohsiek

Fred Ohsiek, Senior Specialist, Cleaning Validation, Novo Nordisk
View Bio

• An overview of regulatory guidelines and requirements for cleaning validation cleaning limits
• Approaches for effective evaluation of cleaning validation and monitoring
• Setting appropriate residue limits for equipment
• Case study on determining suitable validation methods for potent API manufacturing
 

14:40 Afternoon Break and Virtual Exhibit Hall Open

15:10 Analytical Approach for Implementation of Visual Inspection

Mariann Neverovitch

Mariann Neverovitch, Research Scientist, Bristol-Myers Squibb
View Bio

• 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.
 

15:50 Unique scale-up challenges with HPAPIs

Jack D. Brown

Jack D. Brown, Consultant, Formerly of Boehringer Ingelheim Pharmaceuticals
View Bio

• Planning a pilot plant, guidelines and best practices in HPAPI production
• Typical challenges with HPAPIs
• Things to consider prior to scale-up
• Safety in a HPAPI environment
 

16:30 Strategic considerations in the development of a HPAPI facility

Winston Nilumol

Winston Nilumol, Scale-Up Operations Manager, Genentech

• Design and construction overview in the newly commissioned HPAPI facility at Genentech SSF Site
• Implementation of training program
• Integration of the HPAPI facility in a multi-drug product facility
• Key considerations for manufacturing for the future
 

17:10 Chair’s Closing Remarks and Close of Day Two

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Project Services Limited
View Bio

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FEATURED SPEAKERS

Doreen Parrish

Doreen Parrish

Head of Corporate EHS Audit, Takeda Pharmaceutical Company Limited
Ester Lovsin-Barle

Ester Lovsin-Barle

Head Product Stewardship and Health, Takeda Pharmaceutical Company Limited
Florian Grundmann

Florian Grundmann

MSAT Team Leader Cleaning Validation, Roche
Fred Ohsiek

Fred Ohsiek

Senior Specialist, Cleaning Validation, Novo Nordisk
George Petroka

George Petroka

Principal, Director BioPharma/EHS Services , IES Engineers
Ildiko Ziegler

Ildiko Ziegler

QA Manager, Vanessa Research
Jack D. Brown

Jack D. Brown

Consultant, Formerly of Boehringer Ingelheim Pharmaceuticals
Justin Mason-Home

Justin Mason-Home

Director, HPAPI Project Services Limited
Mariann Neverovitch

Mariann Neverovitch

Research Scientist, Bristol-Myers Squibb
Martin Kohan

Martin Kohan

Senior Occupational Toxicologist, AstraZeneca
Olindo  Lazzaro

Olindo Lazzaro

Director, Global EHS Technical Operations, AbbVie
Raphael Nudelman

Raphael Nudelman

Director of Chemical and Computational Toxicology, Teva Pharmaceuticals Industries
Reinhold Maeck

Reinhold Maeck

Head of Corporation EH&S Regulatory Intelligence, Boehringer Ingelheim Pharmaceuticals Incorporated
Richard Denk

Richard Denk

Senior Consultant Aseptic Processing & Containment, SKAN AG
Stefano Butti

Stefano Butti

Head of Sales Group, F.P.S. Food and Pharma Systems Srl
Timo Rosvall

Timo Rosvall

Senior Containment Engineer, TKR Teknik
Toral Mehta

Toral Mehta

SME, Industrial Hygiene, Global EHS, MSD Animal Health
Winston Nilumol

Winston Nilumol

Scale-Up Operations Manager, Genentech

Doreen Parrish

Head of Corporate EHS Audit, Takeda Pharmaceutical Company Limited
Doreen Parrish

Doreen is the Head of Corporate EHS Audit since November 2016. Prior to joining Takeda via Shire, Doreen was the Global Pharma EHS Audit Head with Novartis and Corporate EHS Audit Program Head for Amgen. Her life before EHS/corporate function included Pharma as a R&D chemist, divisional chemical purchasing agent, product manager and project manager for device and hazardous waste operations in chemical. She has spent 28 years (6 companies Abbott, Hospira, Amgen, Novartis, Shire and now Takeda) in Pharma and 2 years working for a Growing media/dirt company.

Doreen holds a degree in Organic Chemistry from Aurora University in IL, USA and two certifications; CPEA (IIA/BEAC) for Auditing and IHMM for Hazardous Material Management.

Doreen was born & raised in Oak Lawn (Chicago), IL. Attended Aurora University in Aurora, IL (famous for the movie Wayne’s World) for undergraduate degree. Lived in 3 US states; IL, GA and RI and overseas; Switzerland. Partner of 23 years with a special needs’ fury child. Her partner works for Roche and has enabled Doreen’s career to physically move and grow.

In her spare time, she enjoys Switzerland’s national past time of hiking / walking with Michele and Jack Jack, pottery and volunteering for in-need organizations. The most important learning in her career was to experience and learn from all people / cultures which makes her successful with her career passion of Audit, specifically T’DA!!
 

Ester Lovsin-Barle

Head Product Stewardship and Health, Takeda Pharmaceutical Company Limited
Ester Lovsin-Barle

Ester Lovsin Barle, DVM, MSc, PhD, MScTox is the Head of Product Stewardship and Health at Takeda. She lives in Zurich, Switzerland. Her responsibilities include Safety Data Sheet process, maintaining article and material regulatory compliance and scientific development and cross-organizational implementation of health based exposure limits (HBEL) in support of research and manufacturing in Takeda globally, global implementation of occupational hygiene and product stewardship sustainability activities. Previously she has held corporate positions at Lonza and Novartis. She received her PhD in veterinary sciences from University of Ljubljana, Slovenia and a second masters degree in toxicology and risk assessment from Medical University in Vienna.
 

Florian Grundmann

MSAT Team Leader Cleaning Validation, Roche
Florian Grundmann

Dr. Florian Grundmann is currently Group Lead Cleaning Validation, Manufacturing Science and Technology at the Roche Kaiseraugst Sterile Production.
Dr. Grundmann studied Pharmacy and earned his Ph.D in molecular biotechnology from Frankfurt University in Germany. He started in the production department of Novartis Pharma Stein AG where he obtained his Lean Six Sigma Green Belt with the technical stabilization of a prototype capsule filler (MG2 Multiflexa) for new inhalation drugs. At Roche in Basel he continued in small molecules drug product Manufacturing Science and Technology with focus on transfers, cleaning validation, cleaning process development and the implementation of continued process verification. After a global assignment where he was responsible, to improve DMS and CAPA performance at the Roche small molecules manufacturing network he worked in the biologics drug substance quality department responsible for the quality oversight for validations.
 

In his latest position as Group Lead Cleaning Validation for steriles manufacturing (biologics and small molecules drug product) he and his team are responsible for cleaning validation oversight & execution from conception to implementation to realization to documentation to life cycle management as well as ensuring compliance to cGMP, PQS and Health authority requirements. As secondmend he is working on the new global process for planned events (change records and CAPAs).
 

Fred Ohsiek

Senior Specialist, Cleaning Validation, Novo Nordisk
Fred Ohsiek

Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability. He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process.  He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.
 

George Petroka

Principal, Director BioPharma/EHS Services , IES Engineers
George Petroka

Principal - George S. Petroka, CIH, CSP

Mr. Petroka has more than 40 years of experience in environmental, safety and health, industrial hygiene, and process safety working within process industries including Sanofi, Sterling Winthrop, Sunoco and Pennsylvania Manufacturers Insurance Company (PMA).
He has extensive experience in the Pharmaceutical Industry having managed Environmental, Health, and Safety (EHS) for Sanofi and Sterling Winthrop. At IES George is a Principal responsible for Biopharma business development and executing and managing BioPharma and EHS Services. An ISPE member for over thirty years as a current member and co-chair for the Containment COP. He has contributed on multiple ISPE Guides including Good Practice Guides: Assessing the Particulate Containment Performance of Pharmaceutical Equipment aka SMEPAC and Decommissioning of Pharmaceutical Equipment and Facilities and Baseline Guide for New and Renovated Facilities - Volume 2 Oral Solid Dosage Forms and Good Practice Guide. Petroka holds an MS in Environmental Science and Engineering from Drexel University, and a BS in Safety Management and a BA in Biology from Indiana University of Pennsylvania. He is both a Certified Industrial Hygienist and Certified Safety Professional.
 

Ildiko Ziegler

QA Manager, Vanessa Research
Ildiko Ziegler

Dr. Ildiko Ziegler has been a professional for more than 15 years in the pharmaceutical industry, has extensive experience in QA, fulfills the QA manager role at Vanessa Research. She has been a validation and quality risk expert for almost 10 years. Ildiko obtained M.Sc. in chemical engineering at the Budapest University of Technology and Economics (BUTE) in 1996. She recieved licentiate degree at the Luleå University of Technology (Sweden) in 2000. She defended Ph. D. at the BUTE in 2000 and obtained the Géza Schay Award for the achievments in the field of physical and theoretical chemistry.

Jack D. Brown

Consultant, Formerly of Boehringer Ingelheim Pharmaceuticals
Jack D. Brown

Raised in Idaho and earned a BS and Ph.D.in Chemistry at Utah State University in Logan, Utah. Continued studies under the direction of Professor Albert I. Meyers at Colorado State University Fort Collins, Colorado. Started professional career at Syntex Chemicals, as a Principle Scientist followed by working for Hoffmann La Roche, until 2002 and rose to the rank of Distinguished Scientist while working on multiple projects, such as Naproxen®, Saquinavir®, Tamiflu®. In 2002 moved to Boehringer Ingelheim Chemicals in Petersburg, Virginia as the Manager of Process Chemistry and stayed there until 2014. Between 2014 to 2019 worked at Boehringer Ingelheim Pharmaceuticals in Ridgefield Connecticut as a Principle Research Scientist and retired in September 2019 as a Senior Research Fellow.

Justin Mason-Home

Director, HPAPI Project Services Limited
Justin Mason-Home

Justin Mason-Home is an organic chemist with extensive health, safety, environmental and chemical engineering experience in senior technical, legal and commercial aspects of the biopharmaceutical, industries. He has held senior positions and worked globally in potent biopharmaceutical occupational health and safety global environmental consulting, board level positions in a biotechnology company and corporate environmental management. Mr Mason-Home specialises in technical complex and strategic projects, including unique experience in managing sensitive highly potent and toxic biopharmaceutical compound matters.

Mariann Neverovitch

Research Scientist, Bristol-Myers Squibb
Mariann Neverovitch

Cleaning Validation Subject Matter Expert with over 15 years of experience in cleaning verification method development and support. Leading cleaning verification program in Support of Clinical Supply Operations for the ten years. Presented a number of papers on Cleaning Validation Lifecycle management and co-authored number of papers along with the international team of industry experts on Cleaning Validation in the 21st Century.

Co-Author of ASTM Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation (E3106-17), Standard Guide for Derivation of Health-Based Exposure Limits (HBELs) (E3219-20), and Standard Practice of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for residues (E3263-20).

Member of the task force team for PDA TR 29.
Member of Eastern Analytical Symposium Governing Board
Member of USP Expert Committee (2015-2020 and 2020-2025 cycles)
 

Martin Kohan

Senior Occupational Toxicologist, AstraZeneca
Martin Kohan

Martin Kohan PhD, ERT, DABT
Position: Senior Occupational Toxicologist, AstraZeneca UK.
BSc/MSc in Biochemistry from La Plata National University, Argentina; MSc in Pharmacology and PhD in Medical Sciences both from the Hebrew University of Jerusalem, Israel. Over 10 years of industry experience in the field of Toxicology conducting and managing over 1000 hazard and risk assessments, including calculation of exposure limits and/or determination of exposure control bands for drug substances and isolated intermediates and quality deviations (impurities and extractables & leachables) for Teva (2010 to 2018) and AstraZeneca (2018 to present). Diplomate of the American Board of Toxicology (DABT), European Registered Toxicologist (ERT), and Member of the UK Register of Toxicologists and of the British Toxicology Society.
 

Olindo Lazzaro

Director, Global EHS Technical Operations, AbbVie
Olindo  Lazzaro

Olindo Lazzaro, is Director Global EHS Technical Operations at AbbVie, responsible for EHS Technical Centers of Excellence supporting both R&D and Manufacturing at Global Level. His key areas of focus are: Process Safety Management, Loss Prevention and Fire Protection, Serious Injury and Fatality (SIF) Prevention, OH/Containment, Pharmaceuticals In the Environment (PiE), Environmental Best Available Techniques (BAT)/Ecoefficiency, EHS Technical Transfer Process, Positive Safety Culture, EHS Management Systems (ISO 14001, ISO 45001, EMAS) and EHS Audit, EHS Business Integration and EHS Performance Improvement.

Previously he has been the Director, EHS, Global Manufacturing & TPMs at Abbott then AbbVie, with Direct accountability for Environment, Health, Safety & Energy (EHS&E) performance and compliance throughout AbbVie’s manufacturing sites and TPMs Globally.
Olindo has 25 years of experience in EHS and Pharmaceutical & Chemical Operations, including international experience in EHS management, Technical Transfer, network optimization and post M&A EHS integration.

His core expertise are:
• Major Hazard identification, Risk Assessment and Control, Process Safety Management (PSM)/Auditing of PSM systems. Fire Protection Engineering, Fire Safety Strategy,
• Occupational Hygiene/Containment, Potent Drugs & Antibody Drug Conjugates (ADCs)
• Pollution Prevention (PP) Environmental Best Available Techniques (BAT) assessment, Eco Management and Audit. Pharmaceuticals In the Environment (PiE) Effluent Management from Manufacturing.
• Positive Safety Culture. EHS Business Integration and EHS Performance Improvement. EHS Management Systems (ISO 14001, EMAS, ISO 45001, ISO 50001).
• Emergency Planning & Response; Crisis Management and Business Continuity

Olindo holds a Master Degree with honors in Environmental Engineering from the Faculty of Engineering, University of Rome “La Sapienza”, a Specialization in Process Safety and Major Hazard Control from the School of Industrial Safety and Protection, University of Rome “La Sapienza” and an EMBA in Pharmaceutical Administration from LUISS University Business School, Rome, Italy.
He is registered as Professional Engineer and Fire Protection Expert in Italy. He is a Certified Occupational Health and Safety Manager, a Certified Energy Manager and he is qualified as Evaluator of Environment Management Systems according to ISO14000 and EMAS rules and as Internal Auditor for the Health and Safety Management System according to OHSAS 18001/ISO 45001 and UNI 10617.
Olindo is member of ISPE (International Society for Pharmaceutical Engineering) Containment Community of Practice (CoP) Steering Committee and of “AESGP, EFPIA and Medicines for Europe –Inter Associations Initiative (IAI)” - Pharmaceuticals in the Environment (PiE) Task Force.
 

Raphael Nudelman

Director of Chemical and Computational Toxicology, Teva Pharmaceuticals Industries
Raphael Nudelman

Raphael has close to 20 years of pharmaceutical industry experience. He attained a M.Sc. degree in Pharmaceutical Sciences from the Hebrew University in Jerusalem, Israel, and a Ph.D. in organic chemistry from the Weizmann Institute of Science in Israel. After completing two postdoctoral positions in the US Air Force Research Lab in Aberdeen Proving Ground, Maryland, and in Duke University Medical Center, North Carolina, and performing molecular modeling in a startup biotech company, in 2003 Raphael joined the Medicinal Chemistry department at Teva Pharmaceuticals and in 2010 he established the Chemical & Computational Toxicology group which he currently heads. Raphael's main topics of expertise are impurity and excipient qualification in drug substances and drug products.
From 2011 to 2016, Raphael was the President of the Medicinal Chemistry Section of the Israel Chemical Society, and was as a Council member of the European Federation of Medicinal Chemistry (EFMC). From 2012 to 2020 he was a member of the Advisory Council of High School Chemistry Education in the Israel Ministry of Education. Raphael is a member of the Advisory Editorial Boards of Elsevier’s journal Drug Discovery Today: Technologies, and of Trends in Medicine and Health (TMH).
 

Reinhold Maeck

Head of Corporation EH&S Regulatory Intelligence, Boehringer Ingelheim Pharmaceuticals Incorporated
Reinhold Maeck

Richard Denk

Senior Consultant Aseptic Processing & Containment, SKAN AG
Richard Denk

Richard Denk is working at the company SKAN AG, headquartered in Allschwil Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard is member of the PDA Isolator Expert Group, ISPE Sterile Product Processing Group, Chair of the ISPE Containment DACH, the ISPE SIG Robotic and Co-Chair ISPE SIG Bio on Innovations and Technology. Furthermore, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group.

Stefano Butti

Head of Sales Group, F.P.S. Food and Pharma Systems Srl
Stefano Butti

Stefano Butti
Head of Sales Group
F.P.S. , Italy

Stefano Butti has studied Mechanical Enineering at university of Milan and graduated in 2000. ISPE member since 2002 he partecipated as speaker to different congress and seminar on Containment and Micronisation topic both for HPAPI and Sterile application as well as published different articles on technical newspaper.
He worked as project and process manager in the Chemical and Pharmaceutical business following Containment and Micronisation system installation worldwide. He also took direct role in the definition of containment system upgrade and optimisation for the handling of products with OEL down to ng level with successful results. Also few projects where combination of sterile and toxic compound handling were succesfully coordinated during the nearly 19 years spent in this business.
He Joined FPS company in 2008 starting as Technical Sales Manager and he is now head of the Sales group for the company Containment and Micronisation system provided worldwide.
 

Timo Rosvall

Senior Containment Engineer, TKR Teknik
Timo Rosvall

Timo Rosvall is an experienced containment engineer with 25 years of experience in pharmaceutical industry and served several companies in Scandinavian and Europe. He has been responsible for a number of containment projects in API , R&D and formulation. Timo is currently working as a consultant for a major Swedish pharmaceutical company.
 

Toral Mehta

SME, Industrial Hygiene, Global EHS, MSD Animal Health
Toral Mehta

Winston Nilumol

Scale-Up Operations Manager, Genentech
Winston Nilumol

Winston Nilumol

Senior Scientific Supervisor, Genentech
Winston Nilumol

Sponsors

Official Media Partner

Supporters

VENUE

Online Virtual Event

Online Virtual Event , Online Virtual Event , United Kingdom

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
HOTEL BOOKING FORM

Speaker Interview with Jack D. Brown, Consultant

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Speaker Interview - Ester Lovsin-Barle, Takeda

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Chair Interview - Jason Mason-Home, HPAPI Project Services Limited

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HPAPi 2021 - 2-day Conference Programme

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HPAPi 2021 Brochure

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HPAPi 2020 Past Attendee List

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Past Speaker Presentation - HPAPI Project Services Limited

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Past Speaker Presentation - SKAN AG

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Past Speaker Presentation - TEVA APi

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Past Speaker Presentation - AstraZeneca - Peter Marshall

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Past Speaker Presentation - Bayer

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Past Speaker Presentation - Pharmadagio Limited

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Past Speaker Presentation - GSK

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Past Speaker Presentation - AstraZeneca

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Sponsors


Catalent

Sponsors
http://www.catalent.com

Catalent Pharma Solutions is a leading, global provider of advanced technologies as well as development, manufacturing and packaging services for pharmaceutical and biotechnological companies. Catalent offers analytical, bioanalytical and immunogenicity testing in addition to mammalian cell gene expression (GPEx®), protein manufacturing, method validation, stability studies, formulation development and regulatory consulting.


FPS

Sponsors
https://www.fps-pharma.com/

FPS is an Italian company specialized in the design and manufacture of containment & isolation systems (toxix and sterile) and micronization solutions for the handling and production of active and sterile pharmaceutical ingredients; it is mainly addressed to pharmaceutical, chemical and cosmetic companies all over the world. Eighteen years after its foundation, FPS today has three sites: head quarter with sales and administrative office in Como, a production plant in Fiorenzuola d'Arda and a commercial office in Philadelphia (US).

With almost 100 employees, more than 1,300 systems in operation worldwide for handling pharmaceutical substances, FPS presents itself on the market as an international company, extremely flexible and able to adapt to different customer's needs.


Media Partners


Speciality Chemicals Online

Official Media Partner
https://www.specchemonline.com/

Published continuously since 1981, Speciality Chemicals Magazine is the leading monthly magazine dedicated to covering business, markets and technology in the fine and speciality chemicals industries world-wide. We have over 50,000 readers and a calendar of features covering the full gamut of applications, including pharmaceuticals, agrochemicals, cosmetics and personal care, biobased chemicals, surfactants, biocides and much more.

Media Partners


International Pharmaceutical Industry

Supporters
http://www.ipimediaworld.com

IPI gives you an insight into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. IPI provides a proven supportive means of communication to the Pharmaceutical, Bio Pharmaceutical, Nutraceutical and Medical Devices industry, incorporating the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies.


Pharmaceutical Outsourcing

Supporters
http://www.pharmoutsourcing.com

Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


Labcompare

Supporters
http://www.labcompare.com

Labcompare is a product of American Laboratory, and is already included in the AL logo on your website. I have attached the standalone Labcompare logo and info is below, but if you do add this one separately, could you exchange the American Lab logo with the one attached? For laboratory managers and researcher scientists across analytical chemistry and applied sciences who need to find product solutions, advice, and access scientific tools. Labcompare provides an industry-leading, comprehensive, online resource of product information to support the laboratory’s needs. Labcompare supports every step of the buying journey by focusing on core and new product technology, supplies, tips, and buyer’s guides.


ASD MEDIA

Supporters
http://www.asd-network.com

Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
  • Be informed on the latest market developments; www.asd-network.com
  • Find the latest business news; www.asd-network.com
  • Find the upcoming events; www.asd-network.com
  • Find companies and organizations; www.asdsource.com
  • Distribute news globally. www.asdwire.com
The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

For more detailed information please contact with: ASD MEDIA
Stefan.koopman@asdmedia.nl


Hospital & Healthcare Management

Supporters
https://www.hhmglobal.com/media-pack



pharmaphorum

Supporters
http://www.pharmaphorum.com

pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


American Pharmaceutical Review

Supporters
http://www.americanpharmaceuticalreview.com

Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


Pharmalicensing

Supporters
http://www.pharmalicensing.com

Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


Gate2Biotech

Supporters
http://www.gate2biotech.com

Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


Drug Discovery Today

Supporters
http://www.drugdiscoverytoday.com/

Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


pharmanews hq

Supporters
http://http://pharmanewshq.com

MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


Mednous

Supporters
http://www.MedNous.com

MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


Pharma network magazine

Supporters
https://www.pharmanetwork.digital

PHARMAnetwork is a company specialized in publishing for the pharmaceutical industry. PHARMAnetwork has developed publications for CMO, CDMO and professionals working in the life sciences. PHARMAnetwork designs specialized studies for pharmaceutical companies, contract service providers and investment firms. PHARMAnetwork magazine covers, every aspect of pharmaceutical value chain, the change and developments in the intersection between pharmaceutical industry and outsourcing industry. We perform interviews and write articles whose thematic strategies, organizations, mergers and acquisitions, regulatory, innovation in the pharmaceutical development and contract manufacturing. https://www.pharmanetwork.digital


Pharmavision

Supporters
http://www.pharmavision.co.uk

PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


Pharma Manufacturing

Supporters
https://www.pharmamanufacturing.com/

Pharmaceutical Manufacturing, is the only publication devoted to serving the informational needs of pharma and biopharma professionals in manufacturing and operations, QA and QC, regulatory affairs, engineering and project management, packaging and corporate management. Pharma Manufacturing magazine and PharmaManufacturing.com are dedicated to being key catalysts for improving the pharmaceutical industry’s: • Manufacturing risk scenarios • Manufacturing and operational efficiencies • Quality control/quality assurance programs • Drug development • Speed to market initiatives • Process development • Compliance/validation programs. www.pharmamanufacturing.com


Pharmaceutical Manufacturing and Packing Sourcer (PMPS)

Supporters
http://www.samedanltd.com/magazine/15

Pharmaceutical Manufacturing and Packing Sourcer (PMPS) is a specialist magazine for the pharmaceutical manufacturing, packaging and supply chain sectors. Every quarterly edition features articles written by key opinion leaders, ranging from pharmaceutical sponsors and key services providers, to industry associations and regulatory authorities. PMPS combines technological, operational and corporate perspectives on this growing sector, along with industry interviews, event previews and book reviews. Now you can also read PMPS on the go with the new Samedan app. Click here to download it now for your iPhone or iPad: http://bit.ly/IJECug


Technology Networks

Supporters
http://go.technologynetworks.com/subscribe-to-newsletters

Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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