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State of Pharma

STATE OF PHARMA

Quality | Regulatory | Clinical | Pharmacovigilance

State of Pharma brings together speakers with a wealth of expertise and experience across a number of different aspects important to the pharmaceutical industry, focusing on key areas that includes quality assurance, regulatory compliance, clinical research and pharmacovigilance.

As the global pharmaceutical industry continues to move forward at a rapid pace, the tools, skills and knowledge of experts and organisational leaders are needed for the industry to thrive. You will hear from these experts and our exclusive speaker lineup of highly sought-after industry professionals.

The conference provides a premier interdisciplinary platform for researchers, practitioners, and representatives from governing bodies to present and discuss the most recent innovations, trends, concerns and practical challenges impacting the pharmaceutical industry at this very moment and will provide details on how to overcome these challenges as it relates to the drug development and manufacturing sectors.

DATE:

May 11, 2023

TIME:

9AM – 5PM EST

GENERAL ADMISSION FEE:​

$99+Taxes

DATE:

EARLY BIRD AND GROUP DISCOUNTS AVAILABLE

REGISTER NOW

EVENT FEATURES

  • In-depth discussions on a wide range of topics related to the pharmaceutical industry
  • Technical knowledge and expertise from industry leaders and representatives from regulatory bodies addressing currently challenges and potential solutions
  • Virtual conference that can be accessed anywhere in the world
  • Two-track approach allowing flexible attendance for only the speakers and talks you want to see

EXPERT SPEAKERS

Our expert panelists consist of regulatory specialists, scientists, and business leaders
providing diverse perspectives on the pharmaceutical industry. Our aim is to deliver valuable educational content and networking opportunities for all attendees.
Laleh Bighash

AAPS

President and Dean of Scientific Affairs

Amanda McFarland

ValSource, Inc

Senior Consultant

Heather Longden

Milford

Consultant

Kenneth Christie

VTS Consultants, Inc.

Chief Operating Officer

Varun Venkatachalam

Consultant

NSF international

Martti Ahtola

Tepsivo

The chief Operating Officer

Adam Brown

ClinArk

Chief Executive Officer

Kim McDonald-Taylor

McDonald-Taylor Consulting

Consultant

Manar Hammood

Zenith PV Solutions Inc.

Founder & Director of PV Operations

SCHEDULE

MAY 11th 2023

  • 9:00 – 9:15 AM

Welcome Remarks

  • 9:15 – 10:00 AM

Developing a Tool Kit and Quality Mindset for Successful Quality Risk Management

Quality Risk Management (QRM) is a systematic process for the assessment, control, and communication and review of risks to quality of the drug product across the product lifecycle. Risk-based compliance is expected by regulatory agencies and strongly recommended by industry to balance compliance efforts and costs vs. product quality and patient safety. Amanda McFarland, a QRM and Microbiology Senior Consultant with ValSource, Inc., will discuss how to apply QRM principles and risk-based decision making consistently, how to use the suite of tools available to manage risk effectively, and how to ensure all levels of management buy-in to the program.

  • 10:00 – 10:45 AM

Utilization of a Quality Risk Management Approach

Quality management maturity is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. While metrics and inspections / audits have been the mainstay for assessing a quality system’s effectiveness and maturity, these are probabilistic and atomistic in practice. A Quality Management Maturity assessment holistically assesses the health of a quality system and provides deep insights into the prevailing quality culture. This session will also discuss the recent efforts by the U.S. Food and Drug Administration (FDA) to secure drug supply chains with the piloting of CDERs QMM program.

  • 10:45 – 11:30 AM

Strategies on Current Challenges in Data Integrity and Identifying Ways to Mitigate Risk

Data integrity is of the utmost importance in pharmaceutical manufacturing. Companies are expected to not only identify risk factors but also mitigate them. What tools do we have at our disposal? What technologies can help to improve our data quality? How often should we be performing maintenance on our system? This session will look specifically at how to maintain data integrity within a laboratory environment and discuss the best ways for organizations to stay ahead and identify, understand, and remediate concerns about paper or electronic forms, spreadsheets or documents used to record GMP data.

  • 11:30 – 12:15 PM

Human Error: Effectively Resolving the Most Common Cause of Quality Failures

Analysis of investigation reports reveal that human error is one of the top root causes for deviations, discrepancies, and quality incidents in pharmaceutical manufacturing. This session will discuss regulatory requirements for detecting, correcting, and preventing human errors in manufacturing and laboratory environments as well as developing a competent, effective corrective and preventive action system. You will learn why human error is often designated as the root cause of deviations and discrepancies, identify why your CAPA’s are less effective than you hoped, understand why human error as opposed to deviations causes deficiencies and learn how to probe further to identify the causes or contributing factors that really cause the problems you are seeing.

  • 12:15 – 1:00 PM

Lunch Break

  • 1:00 – 1:45 PM

Key Considerations for establishing and maintaining compliant PV system and its role in post-market surveillance

Join Manar Hammood, the Founder & Director of PV Operations at Zenith PV Solutions Inc., as she discusses the key considerations for establishing and maintaining a compliant Pharmacovigilance (PV) system and its role in post-market surveillance.

In this session, key elements to be considered in the set-up and maintenance of a compliant PV system in accordance with Health Canada GVP guidelines will be discussed. Additionally, important aspects of post-market surveillance PV activities will be covered. Manar will share her insights and experiences gained from working in Senior Medical and Operations roles in the pharmaceutical industry. She will provide guidance on meeting Health Canada and other global regulatory compliance standards, as well as share best practices for setting up and maintaining a compliant PV system.

  • 1:45 – 2:30 PM

Global Considerations for Periodic Reports, Benefit Risk Management and Risk Minimization and the Lifecycle Implications

Periodic reports, benefit risk management and risk minimization are essential components of pharmacovigilance that require careful planning and execution throughout. In this session, you will learn from Martti Ahtola, COO at Tepsivo, who will discuss the challenges and opportunities of working with different regulatory authorities, data sources and stakeholders across the lifecycle of a medicinal product.

Some of the topics that will be covered in this session include:

  • How to prepare and submit periodic reports (PSURs, PBRERs, DSURs) to different regulatory authorities and what are the common pitfalls to avoid
  • How to conduct benefit risk assessments and communicate them effectively to internal and external stakeholders
  • How to design and implement risk minimization measures (RMMs) that are tailored to different regions and populations
  • How to leverage data analytics, automation and artificial intelligence to streamline and optimize pharmacovigilance processes
  • How to collaborate with other functions (e.g., clinical development, medical affairs, marketing) and external partners (e.g., health authorities, patient groups, healthcare professionals) in a global setting
  • Martti will also present some examples of how Tepsivo uses innovative solutions to streamline and optimize these processes. He will share their best practices, tips and tricks, and innovative solutions to help you optimize your pharmacovigilance activities and ensure compliance with regulatory requirements.
  • 2:30 – 3:15 PM

Clinical Research in a Post-Pandemic World

As the world continues to navigate the ongoing pandemic, it has become clear that the clinical research landscape has undergone rapid and unprecedented changes. To explore these changes and discuss the latest trends and advances in clinical research, we invite you to join us for an insightful session on clinical research in a post-pandemic world.

Our expert speaker, Kim McDonald-Taylor, MSc, CRPC, is an industry leader with extensive experience in project management, SOP creation/review, medical writing, teaching, meeting facilitation, and strategic planning. Kim will share her expertise in these areas and discuss how these practices have evolved in the new normal, including the use of decentralized CTs, remote monitoring, and Zoom meetings.

  • 3:15 – 4:00 PM

Clinical Trial Design and Alternative Data Sources (e.g. Diversity, real-world data, precision medicine and patient-focused drug development

Clinical trials are essential for advancing medical knowledge and improving health outcomes. However, designing and conducting clinical trials can be challenging, especially when dealing with rare diseases, diverse populations, real-world data, precision medicine and patient-focused drug development. How can researchers overcome these challenges and optimize their trial design using alternative data sources? Join Adam Brown, Founder and CEO at ClinArk, as well as a researcher and community advocate with extensive experience in community-based participatory research approaches, as he shares his insights and best practices on this topic.

Adam will discuss:

  • How to leverage different types of source documents.
  • How to use hybrid trial methodology that combines traditional randomized controlled trials (RCTs) and observational study designs.
  • How to apply alternative designs such as cross-over and n-of-1 trials, enriched enrollment, randomized withdrawal design, and adaptive designs.

Whether you are a novice or an expert in clinical trial design, you will benefit from this session that will help you enhance your evidence-based practice using real-world data.

  • 4:00 – 4:15 PM

Closing Remarks

* Agenda and speakers are subject to change

OUR SPONSORS

More to come

If you are interested in sponsorship opportunities at the State of Pharma conference, contact us today!

SPONSOR STATE OF PHARMA

AAPS is the Canadian premier Life Sciences training college. The school was established in 2003 to address the growing demands for better prepared and more practically trained applicants. In tailored response, AAPS was designed and made operational by a team of highly experienced industry experts with one mission in mind; to create professional skill development programs that would exceed industry-training standards”. Employing only leading industry professionals with decades of experience, AAPS is setting the standard for pharmaceutical, food and healthcare, and Cannabis training and career advancement. These experts continually develop and update the diploma and certificate programs and certificates courses at AAPS to meet the rigorous demands of the industry.

STATE OF PHARMA POWERED BY AAPS
Laleh Bighash​

AAPS

President and Dean of Scientific Affairs​

Ms. Bighash has a Bachelor of Pharmacy, and a Bachelor degree in Pharmacology and Toxicology from University of Toronto, Canada. She also obtained her Masters degree in Business Administration (MBA) from Schulich School of Business. She is a recipient of 2019 UC-University of Toronto alumni of influence award and has been nominated for the Canadian Women Entrepreneur Award. In her current role as the President of AAPS, a post-graduate private college focusing on pharmaceutical and food higher education, she oversees the strategic, educational and training direction of AAPS. She has over 27 years of experience working for a number of multinational pharmaceutical companies such as Genpharm Inc., Bayer Corp. and Eli Lilly & Company. Laleh has also worked with a number of Food and Cannabis organizations in various capacities such as Research and Development, Quality Control, Quality Assurance, Regulatory and Compliance, Strategic Planning, and Business development.

Ms. Bighash has lectured extensively and has been an invited speaker at many global and Canadian academic and industry events focusing on pharma, food and cannabis-related topics such as regulatory, compliance and efficient operations. She has worked closely with the industry players and stakeholders in formulating efficient operating systems, ensuring regulatory compliance and certification.

Amanda McFarland

ValSource, Inc

Senior Consultant

Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and a member of the Kilmer Regulatory Innovation team. She has a B.S. in entomology and an M.S. in mycology, both from the University of Florida. She can be contacted at amcfarland@valsource.com.
Heather Longden

Milford

Consultant

Heather Longden is an independent regulatory compliance consultant to the pharmaceutical industry. Heather specialises in data integrity, regulatory compliance, data management, GLP and GMP and computer system validation. She acts as an advisor to various regulatory groups, specifically as a leader at GAMP® Americas steering committee and serves on the the ISPE Boston Area Chapter Board and Education Program Committee (EPC).
Kenneth Christie

VTS Consultants, Inc.

Chief Operating Officer

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, supplier qualification, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Accomplishments include working on consent decree remediation issues for aseptically produced products, assisting clients in Japan, Dubai, Spain, China, and India by addressing audit observations and corrective actions dealing with sterilization. Performs PAI’s (pre-approval inspections) against current standards as found in the FDA’s ‘Pre-Approval Inspection Compliance Program #7346.832.

Mr. Christie is a speaker and trainer for several professional organizations and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
Varun Venkatachalam

Consultant

NSF international

Varun is passionate about Quality Management Maturity and Human Performance in the Lifesciences Manufacturing sector. With over 12 years of experience across Industry and Management Consulting, Varun is a multifaceted professional with commercial (Due Diligence, Strategy and Operational excellence) and technical (Regulatory, Quality and Manufacturing Systems) expertise across the Life Sciences sector.

Varun started out his career in the consulting industry, advising life sciences clients on technology adoption and process improvements. He then moved to Pfizer, working in multiple roles across Operations, Manufacturing and Quality. Subsequently, he took up roles in management and strategic consulting for the Life Sciences sector at PwC and EY. He is currently a Principal consultant for the Pharma & Biotech industry at NSF international, based out of Toronto.

Varun has an undergraduate engineering degree in Biotechnology and a master’s in biotechnology. He is currently pursuing his Global Executive MBA in Healthcare/Life Sciences at the Rotman School of Management, UofT.
Martti Ahtola

Tepsivo

The chief Operating Officer

Martti is a pharmacist from Finland and I have graduated from the University of Helsinki. His professional background is in the different areas of the international pharmaceutical industry but has also worked in the largest community pharmacy in Finland and one of the main hospital pharmacies in the country. Currently, Martti act as the chief operating officer at Tepsivo and as a co-founder / operations of RemedyBytes. Tepsivo is a service and product provider for the pharmaceutical industry specialized in the areas of pharmacovigilance, regulatory affairs and clinical data management. RemebyBytes provides services related to healthcare data management and data requests to the registries and databases.

His current role contains a wide range of responsibilities related to process development and management for drug safety and related areas, acting as a product owner for database and automation products, managing teams and a global network of experts, authoring documentation etc. The main driver for Martti is the urge to push things forward in all areas within Tepsivo and RemedyBytes but also in the industry in general.
Adam Brown

ClinArk

Chief Executive Officer

Adam Brown is a researcher and community advocate. He attended Wittenberg University in Springfield, Ohio, with a bachelor’s degree in biology. Throughout Adam’s professional career, he has been a senior research associate, global analyst, executive, and board member. Adam was listed on Venue Magazine’s 40 under 40 lists in 2021 and featured on the Cincinnati Business Journal cover for his work. As an executive, he founded ClinArk to help small and large life science companies with community engagement by implementing community-based participatory research approaches to build awareness around community health. In addition to this experience, Adam previously served as a board member at The Conscious Connect Community Development Corporation (CDC), where he helped develop strategies to help advanced equitable access to the park and green spaces for residents in southwest Ohio. Adam is passionate about helping improve research and communities in ways that will enhance and address the quality of life and health outcomes for communities
Kim McDonald-Taylor

McDonald-Taylor Consulting

Consultant

Kim McDonald-Taylor, MSc, CRPC operates a clinical consultancy, McDonald-Taylor Consulting, where her passion for her clients’ projects results in exceeded expectations for her training, project management, SOP creation/review, medical writing, teaching, meeting facilitation and strategic planning. Kim has worked in the clinical trials area for 35 years, including her 12-year tenure with Endpoint Research holding positions such as VP Operations and Managing Director of Canada. She has worked in virtually every therapeutic area. Kim received the Excellence in Clinical Research award in 2018 at the Canada Talks Pharma conference. Kim has volunteered with the Clinical Research Association of Canada (CRAC) ™ for the past 22 years. In her various roles, including President, Kim has provided leadership as CRAC went online, helped develop a certification program (CRPC) and continues to recommend quality speakers for the membership on topics of importance in Canadian clinical research. She volunteered on the Board of Directors for Brain Injury Canada as secretary from 2013-2019 and was named Volunteer of the Year for 2016. Kim earned her MSc in toxicology from the Ontario Veterinary College at the University of Guelph. She has presented and co-chaired sessions at DIA, DIA Canada, ACRP and other meetings over the past 25 years. In her spare time, Kim enjoys photography, birding, genealogy, music and downhill skiing. You can follow her on Twitter @kimmcdt.
Manar Hammood

Zenith PV Solutions Inc.

Founder & Director of PV Operations

Manar Hammood is the Founder & Director of PV Operations at Zenith PV Solutions Inc. Zenith specializes in providing the pharmaceutical industry, guidance and support in ensuring that all medications used in Canada meet strict drug safety reporting standards established by Health Canada. Zenith is a fast-growing company with a talented team, supporting large and midsized pharmaceutical companies and hospitals across Canada. After spending some time in Senior Medical and Operations roles in the pharmaceutical industry, now as a spirited and enterprising entrepreneur, Manar has helped several firms meet Health Canada and other global regulatory compliance standards.