Enhancing Pharmacovigilance

To give oncology products the best possible opportunity

By: Dr Brian Edwards, Principal Consultant, NDA Group 

In this article, Dr Brian Edwards follows on from his very successful webinar, Opportunities to enhance Pharmacovigilance in Oncology, to argue that to maximise the benefits of innovation in our products we need innovative pharmacovigilance.


We are witnessing a tremendous expansion in oncology products with great opportunities that will benefit patients. Regulatory agencies have responded with expedited review pathways and schemes to enable early access. Data sources such as patient reported outcomes and real-world evidence are being adopted, especially once the product is marketed. The products may often be dependent on biomarker kits which have arisen from the exciting progress in genomic and stratified medicine.

Throughout healthcare and the life sciences, technologies such as machine learning or artificial intelligence are being introduced with great expectation about increased cost efficiency and productivity. With this greater importance of pharmacovigilance (PV) within a changing environment, we need to adapt to recognise limitations of certain data so that the quality that can be reasonably expected will differ if we are to strengthen current standards of PV.

However, we put all this progress at risk if we do not respond effectively to warning signs about medical quality, timely follow up and completeness of adverse drug reaction (ADR) case reports that could undermine confidence in novel oncology products by impairing the ability to make informed decisions.

For that reason, in their 2015 Guidance, the FDA urges sponsors not to report all serious adverse events, including those where there is little reason to consider them suspected adverse reactions.* Study investigators agree. There seems to be misinterpretation of what should be sent to sites resulting in examples where all reported adverse events are sent to every site that conducts a trial that uses that agent, regardless of relevance.

The full article was published in Volume 69 Spring 2020 of Pharmafile – Therapeutic areas in focus. 

Click to the full article
 

To learn more about NDA’s Pharmacovigilance services and how we can help you, click here.

*Safety assessment for IND safety reporting guidance for industry, Food and Drug Administration, 2015, https://www.fda.gov/files/drugs/published/Safety-Assessmentfor-IND-Safety-Reporting-Guidance-for-Industry.pdf

Pharmacovigilance Audits and Inspections Summit – November 7, 2018

Shelley Gandhi has been invited to present a session at the Pharmacovigilance Audits and Inspections Summit – November 7, 2018 • Wyndham Philadelphia Historic District • Philadelphia, PA

Her session will cover:
Examine Evolving Global Pharmacovigilance Regulations and the Impact on Audit and Inspection Readiness

As regulations are changing domestically and around the globe, it is important to keep
up to date on the many different regulatory issues (including data integrity regulations)
that affect your audits and inspections. During this session, learn more about current
and pending regulatory developments that affect PV audits and inspections.


LEARNING OBJECTIVES

Align Global Data Collection and Analysis Systems • Ensure Cross -Functional Collaboration and Preparedness • Achieve Accurate and Timely Reporting

  • The volume of audits and inspections is growing rapidly
  • Audits and inspections currently consume an inordinate amount of PV’s time and attention
  • Global PV regulations are incredibly detailed
  • Managing, reviewing and sharing an increasing amount of data is tremendously complex
  • Cross-functional cooperation and seamless collaboration with 3rd parties is critical

ATTENDEE BENEFITS INCLUDE:

  • Understand areas of regulatory focus related to PV audits and inspections
  • Create internal processes and best practices for managing audits and inspections
  • Benchmark with colleagues — Consider ways to work in partnership with regulatory affairs, quality, medical affairs, clinical development and manufacturing
  • Examine ways to efficiently and effectively capture, manage and report on data
  • Consider the future state of PV audits and inspections

Click here to find out more.

 

 

Meet NDA at DIA European Forum for Qualified Person for Pharmacovigilance (QPPV)

Helen Powell, & Brian Edwards, Principal Consultants at NDA Group have been invited to chair two Sessions at DIA European Forum for Qualified Person for Pharmacovigilance (QPPV), London, 10-11 October 2018

“Are You Compliant Enough? – Audits, Inspections And QMS”
Helen Powell, Principal Consultant, NDA Group has been invited to chair session 7

 

 

“Am I Impacted By Brexit?”
Brian Edwards, Principal Consultant, Pharmacovigilance and Drug Safety, NDA Group, will chair session 8

 

 

Overview
This is still the only forum designed for QPPVs by QPPVs. This Forum continues to identify key trends requiring QPPV awareness, input and oversight. This year’s objectives, will build on past successes which have been shaped by valuable feedback provided by the participants of the past eleven meetings, plus many years of QPPV and Regulator interaction at this Forum.

Objectives
• Hear the latest updates and hot topics relating to the role of the QPPV
• Explore long term PV visions, future directions of the ‘PV world’, and potential impact on the role of QPPV
• Network with colleagues and meet regulators
• Learn from and share experience and ideas with like-minded QPPVs in a neutral environment
• Take away practical hints and tips
• Better understand regulatory and inspectorate expectations of the QPPV
• Identify the expanded expectations of the role in the context of the continually evolving regulatory framework
• Examine current areas of real challenge

To find out more about the event click here.

Advanced Workshop in QPPV Toolbox – Your Key to Success

Shelley Gandhi to conduct an Advanced Workshop in QPPV Toolbox – Your Key to Success – in conjunction with DIA Learning

Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group, has been invited to lead the Advanced Workshop in QPPV Toolbox on the 12-13 March 2018 at Adina Apartment Hotel Berlin Checkpoint Charlie, Berlin, Germany.

 


The workshop is designed to include small group interaction and discussions and is based on suggestions from the QPPVs themselves. The workshop will allow you to be more efficient in solving the problems in your daily business, learn the right thinking processes to land at good results and hear from solutions from other in similar situations.

LEARNING OBJECTIVES
At the conclusion of this course, participants will be able to:

• Master the obligations of marketing authorization holder and QPPV – your
responsibilities
• Prepare and go through the audits and inspections without major issues
• Navigate the changes in the QPPV role in a global commercial environment
• Achieve oversight of the PV system
• Set up a complete system: a QPPV Backup and delegating PV activities

KEY TOPICS
• PSMF oversight
• Quality management
• Vendor management
• Delivering a successful inspection
• QPPV in the global environment – European and international considerations

WHO WILL ATTEND
This workshop is intended for QPPVs who are already established in their role and would like to
improve their daily practice.

Click here to find out more

Strategic alliance to support efficient, ethical practices in biopharma industry

Clinton Allen CEO Ethiprax LLC
Fabiana Lacerca-Allen President Ethiprax LLC
Johan Strömquist CEO NDA Group

 

New Collaboration offers broad range of Compliance-and Risk Management Strategies in Europe and US to Life Science Industry


Hayward, CA and Stockholm, Sweden (07-12-2017) – Two leading drug development and regulatory consultancies announced today that they have formed a new strategic collaboration to help life science companies navigate an increasingly complex global environment. Ethiprax Associates LLC – a leading Compliance and Ethics solutions consultancy based in the US – and NDA Group – a world leading integrated regulatory/drug development consultancy are now collaborating to provide the life science industry with truly integrated, trans-Atlantic Compliance-and Risk Management strategies.

Fabiana Lacerca-Allen, President of Ethiprax LLC commented:
“As we are intimately familiar with compliance requirement both in the US and Europe, we are able to help clients develop and maintain effective cultures of compliance. Too often companies hire one firm for US and another for EU and fail to implement a compliance culture across the entire organization. This collaboration offers a single partner who can provide global solutions.”

Johan Strömquist, CEO of NDA Group commented:
“We recognize that life science companies operate in different regulatory environments but fundamentally they all need to implement global best practices to maximize their opportunities for success. This is where we can add tremendous value. Doing the right things right doesn’t just feel good – it is the optimal way to create value.”

Strömquist continues:
“Together with Ethiprax we extend the reach of our services and our geographic foot print on the US west coast – much in line with our growth strategy. This continues to bring the experience biotechs and pharmaceutical companies need closer to where they are.”

The NDA Group and Ethiprax collaboration will focus primarily on the following:

  • Assess regulatory compliance readiness in early stage programs.
  • Provide strategic assessments of emerging compliance needs, review existing programs and provide advice regarding best practices to optimize critical business processes.
  • Align diverse teams to support manufacturing, clinical and product safety reporting requirements to connect the dots in compliance program development and implementation.
  • Offer compliance assurance program design, policies, procedures and program execution.

 


About NDA Group
NDA is an independent consulting group with offices in Stockholm, London, Zürich, Munich, Princeton, Boston and San Francisco. Its mission is to ensure that good medicines reach patients without unnecessary delay. It accomplishes this by providing the pharmaceutical industry with a comprehensive range of professional drug development services focusing on regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team of more than 150 full time professionals is comprised of more than 25% ex-regulators from major EU Agencies, and a specialist Advisory Board consisting of Europe’s leading regulatory and HTA experts. The NDA Advisory Board provides scientific advice to pharmaceutical companies supporting them in gaining fast and constructive assessment of applications from regulatory agencies and HTA bodies.

NDA supported over 40% of the new medicinal products that were approved in the EU over the past four years. http://www.ndareg.com/

About Ethiprax
Ethiprax is a specialized consultancy operating out of Hayward CA in the USA. Ethiprax was formed to help companies manage compliance and ethics risk. Drawing upon extensive experience related to healthcare-related organizations, Ethiprax helps clients develop and maintain effective cultures of compliance. Ethiprax brings industry best practices to the life sciences industry, ensuring that compliance requirements are addressed. http://ethiprax.com/

NDA Media Contact
Anna Perrin anna.perrin@ndareg.com

Ethiprax Media Contact
Allen Clinton clinton.allen@ethiprax.com


Shelley Gandhi Chairs the 2nd Annual Biosimilars Europe Congress

Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group, has been invited to Chair the 2nd Annual Biosimilars Europe Congress Nov 23 – 24, 2017 at Hilton London Olympia, London.

The conference will bring together industry experts to explore the strategies to gain insight into new biosimilar development strategies, different characterization and analysis methods, clinical advancement and successful case studies.

This conference offers a rare opportunity to its participants to understand and learn from top experts in the biosimilars field and to share experiences. The conference will also provide a platform to discuss the current vital issues, regulatory issues, market assessment and commercialization and globalization.

Key themes:

  • Current status of Biosimliars market
  • Monoclonal antibody Biosimilars
  • Challenges faced when moving towards globalization
  • Opportunities in emerging markets
  • IP issues, naming and labelling issues related to biosimilars
  • Partnership, new investment and business models
  • Challenges and opportunities for biobetters and monoclonal antibody biosimilars
  • Clinical trials strategies and new guidelines for biosimilar clinical trials
  • Benefits and concerns of interchangeable and biosubstitutes and post authorization monitoring
  • Bringing biosimilars closer to patients and healthcare professionals
  • New solutions to demonstrate similarity and different characterization methods

To find out more about the event click here.

 

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Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group

Meet NDA at the 11th Annual Forum for Qualified Persons in Pharmacovigilance

NDAs Brian Edwards, Principal Consultant Pharmacovigilance & Drug Safety, is on the programme committee at the 11th Annual Forum for Qualified Persons in Pharmacovigilance, QPPV, at The Crystal, London, UK 4-5 October 2017. Dr Edwards is also chairing session 5 – Insights on Inspections, Audits and Quality Management – on 5th October.

This is the only forum designed for QPPVs by QPPVs, now in its 11th year and ever growing. This year’s objectives build on past successes and have been shaped by valuable feedback provided by participants.

Objectives

  • Build relationships with fellow QPPVs
  • Reconnect with colleagues and meet regulators
  • Hear the latest updates and hot topics relating to the role of the QPPV
  • Explore long term PV visions, future directions of the ‘PV world’, and potential impact on the role of QPPV
  • Learn from and share experience and ideas with like-minded QPPVs in a neutral environment
  • Better understand regulatory and inspectorate expectations of the QPPV
  • Identify the expanded expectations of the role in the context of the new regulatory framework and transparency initiatives

To find out more about the event click here.

 

 

 

 

 

Brian Edwards, Principal Consultant Pharmacovigilance & Drug Safety NDA Group

NDA’s Brian Edwards speaks at the ISoP Latin American Chapter in Mexico

Dr. Brian Edwards, Pharmacovigilance veteran and expert at NDA Group, is the ISoP Chapters Coordinator and will present at the Latin American Chapter 4th symposium, which is being held in Mexico, between 28-29 September.

Dr. Edwards will give presentations about ‘RMP: Trials and tribulation, lessons to be learned’ on September 28th and about ‘Present regulation in biologic therapies’ on September 29th.

The main objective of the Latin American chapter is to develop educational activities with the aim to increase knowledge and to ensure trainings in the field of Pharmacovigilance. This chapter is an independent forum for people working in regulatory agencies, academia, hospitals, and also in pharmaceutical companies.

To read more about ISoP click here, for downloading the agenda click here.

 

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Dr Brian Edwards Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group

 

Have you ever wondered why compliance with regulations is so difficult?

What do we mean when we say ‘safety is everybody’s responsibility’? What is meant by risk-based compliance? What is the basis for an effective safety system?

The reality is that humans will make mistakes so that ultimately safety and quality is all about human performance.

To find out more read the full article that has been published in Quasar written by NDAs Dr. Brian Edwards.

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Dr Brian Edwards

 

 

 

 

Dr Brian Edwards Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group

 

 

Signal Detection and Interpretation in Pharmacovigilance

Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group, has been invited by the Drug safety Research Unit (DSRU) to present a session re. Case Studies during the Pre- conference tutorial on Tuesday 6th June.

This is being held at the 9th Biennial Conference On Signal Detection and Interpretation in Pharmacovigilance at the British Medical Association House, London.

Since its inception in 2001, the DSRU Biennial Conference on Signal Detection has established itself as one of the largest and most important meetings in the pharmacovigilance calendar.

This conference delivers the best available knowledge and new developments, featuring internationally renowned experts in signal detection and pharmacovigilance and has built up a loyal following.

Click here to see the agenda.

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Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group

Global Pharmacovigilance Regulatory Requirements: What’s New?

Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group, has been invited by Drug Safety Research Unit (DSUR) to chair the course ‘Global Pharmacovigilance Regulatory Requirements: What’s New?’ in London 31 May – 1 June.

In our global pharmacovigilance market the legislation requires the Marketing Authorisation Holder (MAH) of medicinal products to have a pharmacovigilance system where all aspects comply with the requirements of the appropriate regulatory authority. As more MAHs work globally it is increasingly important that they understand local differences in requirements for compliance around the world including inspection procedures and legal implications.

This course brings together a panel of international experts from industry, regulatory and legal backgrounds to provide up-to-date information on all aspects of compliance in pharmacovigilance (both pre-marketing and post-marketing) for Europe, the USA, Latin America, Russia, Africa and Japan including inspection and legal implications.

Click here to find out more about the event.

 

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Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group

 

 

 

Dr Edwards presents at the 9th DIA China Annual Meeting

Dr Brian Edwards, Principal Consultant & Pharmacovigilance Expert, has been invited to speak at this year’s DIA China, May 21-24 at Shanghai International Convention Centre, China.

The theme of this meeting, “Drug Innovation Driven by Unmet Medical Needs”, will attract more than 2000 pharmaceutical R&D professionals from different continents and regions, involved at all levels of the health care product development spectrum.

Brian will be presenting at the following sessions:

Monday, 22nd May – Satellite Session:
ISOP China Chapter
Post-authorisation safety studies (PASS): EU experience

Tuesday May 23rd at 08:30- 10:00
Session 0801 Current Development in Pharmacovigilance –
The importance to know What’s going on – “Being Biosimilar means having similar systems to manage risk: But what does that Mean?”

Please click here to read more about this event.

 

Dr Brian Edwards

 

 

 

 

Dr Brian Edwards Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group

 

 

 

 

Pharmacovigilance Europe Congress

Shelley Gandhi, Strategic Advisor, Pharmacovigilance & Drug Safety NDA Group, has been invited as a Key Speaker at the Pharmacovigilance Europe Congress 2017, 24-25 May, at Hilton London Olympia, UK.

Striving towards globalising and strengthening pharmacovigilance, the Pharmacovigilance Europe 2017 conference is a platform to share experiences and knowledge on the many concerns and advancements in the field.

One of the key aims will be to study the current trends of the PV aspect on EU legislations, Signal detection management, PV audit and inspections and role of PV in biologics. As networking is a prime tool for knowledge sharing, the conference will have networking sessions where experts and a mix of professionals can interact and discuss.

Click here to find out more about the event.

 

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Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group

 

 

 

Considerations for Good Pharmacovigilance Outsourcing

Over the last approximately 20 years, the pharmaceutical industry has increasingly outsourced its research and development activities, including pharmacovigilance, with mixed results.

This article, co-authored by Brian Edwards, explains the importance for both clients and service providers to understand and openly discuss each other’s needs to avoid the unrealistic expectations often elicited prior to signing a contract.

 

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Dr Brian Edwards Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group