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SMi is delighted to announce its 5th Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London 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, cleaning validation, prevention of cross-contamination, strategies for scaling-up, the expanding ADC market beyond oncology.


This year’s event will focus on 4 key themes: best practices for toxicological assessment, innovations in containment and facility design, advances in accelerated ADC production, and environmental considerations for HPAPI manufacture. 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 form leading pharmaceutical and biotechnology companies.

  • EXPLORE best practices in hazard assessment and occupational toxicology
  • UNDERSTAND strategic considerations for planning pilot plants and scaling up manufacturing capabilities for high potency compounds
  • DISCOVER potential for automation and robotics in pharmaceutical manufacture and technologies for protecting operators from hazardous substances
  • DISCUSS the opportunities for effective CDMO relationships and explore methods for strengthening those partnerships
  • DELVE into the expanding ADC market within and beyond oncology
     

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;

FEATURED SPEAKERS

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
Ildiko Ziegler

Ildiko Ziegler

QA Manager, Vanessa Research
Justin Mason-Home

Justin Mason-Home

Director, HPAPI Project Services Limited
Mariann Neverovitch

Mariann Neverovitch

Research Scientist, Bristol-Myers Squibb
Olindo  Lazzaro

Olindo Lazzaro

Director, Global EHS Technical Operations, AbbVie
Raphael Nudelman

Raphael Nudelman

Director of Chemical and Computational Toxicology, Teva Pharmaceuticals Industries
Richard Denk

Richard Denk

Senior Consultant Aseptic Processing & Containment, SKAN AG
Timo Rosvall

Timo Rosvall

Senior Containment Engineer, TKR Teknik

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.
 

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.

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)
 

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).
 

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.

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.
 

VENUE

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London, United Kingdom

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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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