NDA authors Mann’s Pharmacovigilance

Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics.

Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field.

Shelley Gandhi and Brian Edwards have written chapter 2 Legal Basis – European Union under the headline The Regulatory Basis of Pharmacovigilance.


Shelley Gandhi
Shelley Gandhi
Brian Edwards
Brian Edwards

Brian Edwards presents at ISoP 2014 Asia

One of NDAs pharmacovigilance experts, Dr. Brian Edwards, is presenting at this years 14th Annual Meeting of International Society of Pharmacovigilance (ISoP 2014) entitled ‘New Ideas to Ancient Cultures: Advancing Pharmacovigilance in Asia’ to be held at the Holiday Inn Tianjin Riverside, Tianjin, China from 19 -22 October 2014.

This meeting, which is being organised by the China Food and drug Administration, will focus on the latest developments in pharmacovigilance and thoughts for future perspectives in China and the Asian-Pacific region. It will address new technologies and treatment concepts, pharmacogenomics and personalized medicine, new methodologies in pharmacovigilance, risk management and outcome measurement, clinical aspects of specific ADRs, pharmacovigilance on herbal medicinal products and ethno-pharmacovigilance, and, ADRs in specific populations and treatments. A special focus will be given to young scientists and healthcare professionals dedicated topharmacovigilance.

Brian will speak on the subject of ‘US and EU Approaches to Risk Management – what have we learnt?’, which takes place on Tuesday, October 21st, 2014.
Brian is also the Chair for that session, in addition to being involved in a roundtable discussion on the topic of ‘New developments in pharmacovigilance and beyond’ that afternoon, at 14.30.

For further information on the event, click here.








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


Analyzing Overall Survival in Randomized Controlled Trials with Crossover and Implications for Economic Evaluation


Offering patients in oncology trials the opportunity to crossover to active treatment at disease progression is a common strategy to address ethical issues associated with placebo controls but may lead to statistical challenges in the analysis of overall survival and cost-effectiveness because crossover leads to information loss and dilution of comparative clinical efficacy.

The article provides an overview of how to address crossover, implications for risk-effect estimates of survival (hazard ratios) and cost-effectiveness, and how this influences decisions of reimbursement agencies. Two case studies using data from two phase III sunitinib oncology trials are used as illustration.






Biotech and NCE Client Seminar in Boston

How confident are you of getting your biologic and new chemical entity drug into the EU market?

FREE seminar for biotech companies

NDA Group, Europe’s leading regulatory, pharmacovigilance and HTA consultancy, is holding a breakfast seminar on Thursday, November 6th, 8.30am – 11.00am, at the MassBio HQ in Boston.

The event is being chaired by NDAs strategy advisor Dr. Thomas Lönngren – former head of the European Medicines Agency (EMA); Member of NDA Regulatory Advisory Board, Dr. Eric Abadie – former chairman of the EMA Committee for Human Medicinal Products (CHMP); and NDA Principal Consultant, Dr. Gopalan Narayanan – former member of the EMA Committee for Advanced Therapies (EMA/CAT) and Gene Therapy Working Party (GTWP).


Dr. Thomas Lönngren
Dr. Thomas Lönngren
Dr. Eric Abadie
Dr. Eric Abadie
Dr. Gopalan Narayanan







The event will cover two key areas:

  1. Unique EU regulatory insights: What a US company needs to know about the regulatory framework for the lifecycle of a medicinal product and the market access requirement for a successful launch of a drug in EU.
  2. The competitive edge: A special US insight into the EU legislation on Advanced Therapies – covering gene therapies, cell-based products, and tissue engineered products and combined advanced therapies.


Enquires about participation, please email: usa@ndareg.com

Breakfast Seminar details

Date: Thursday, November 6th
Time: 8.30am – 11.00am
Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA 02139
Bookings: Email: usa@ndareg.com

Outline Agenda

8.30am –   Arrival / breakfast
8.45am –   Welcome: Challenges and opportunities in Europe
9.00am –   How to manage your EU application for MA – presentation and Q&A
10.00am – Advanced Therapies – what can the USA learn from the EU experience? EU special legislation for advance therapies, gene therapies, tissue engineering and stem cell + Q&A
11.00am –  Round-up and close, individual meetings










The EU regulatory system touches over 500 million people and soon celebrates its 20th anniversary. It is recognised, along with US FDA, as a global leader for performance and scientific excellence in the field of medicines regulation. The complexity in evidence generation for market authorisations and market access is increasing. To navigate a new drug application in the EU landscape relies on local knowledge that many companies are unsure of. In connection with opening a new office in Boston, we invite you to meet some of NDAs ex regulators – all have been involved in shaping and running today’s EU regulatory system.

Dr. Pieter Neels speaks at the 11th TOPRA Annual Symposium

NDA’s Pieter Neels will give a talk on vaccines highlighting why vaccines are important, and very different from other medicinal products. He will also clarify why vaccines are not easy to develop and why regulatory agencies best specialize in a few topics in the European Union and this on top of the generic knowledge of regulatory affairs.

For more information and to register click here.








Dr. Pieter Neels, NDA Group Clinical Expert and Advisory Board member

IMMUNOGENICITY: Understanding the Regulatory Philosophy

NDA Advisory Board’s Scientific Director, Dr Markku Toivonen, and Paul Chamberlain, Biopharmaceuticals and Immunogenicity Specialist, will be joining Dr Pekka Kurki (Finnish Medicines Agency & Expert to BMWP), in a 1.5-day interactive EUCRAF workshop, 13-14 October in Munich, that will address opportunities for optimizing presentation of immunogenicity-related data in regulatory submissions.

This workshop is very timely because it coincides with the revision of the main EU guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins (CHMP/BMWP/42832/2005).

For more information on the workshop please click here.


Markku Toivonen
Paul Chamberlain

Brian Edwards speaks at ISoP Latin America

NDA’s pharmavovigilance expert, Brian Edwards, has been invited to speak at the Latin American chapter of the International Society of Pharmacovigilance ( ISoP) on 2-3rd October. The meeting, which takes place in Buenos Aires, looks at training in PV and the safety of biological products. Dr Edwards is the only international invited speaker and he will give two talks on the challenges of biological safety and good registry practice.

For further information click here.








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


NDA’s Christian Redondo-Müller shortlisted for TOPRA Award

Principal Consultant, Christian Redondo-Müller, has been shortlisted for the ‘Contribution’ Award in this year’s TOPRA Awards for Regulatory Excellence.

The award recognises “regulatory professionals who have made a significant and consistent contribution to a regulatory team, a project, or to a regulatory science or to the profession within the past three years. They can be an internal member of the team or an individual contractor or consultant. They will have a level of expertise and practical knowledge that inspires respect and confidence among their colleagues and external contacts. They will drive forward standards and good practice in regulatory affairs and lead by example by keeping up to date with current legislation and regulatory practice.”

The winners will be announced at the Awards Dinner at the Royal College of Surgeons, London on Tuesday 9 December 2014.








Christian Redondo-Müller, Principal Consultant NDA Group

Dr. Lönngren participates in a reactor panel on patient access to orphan drugs

NDA’s Thomas Lönngren will participate in a reactor panel on patient access to orphan drugs in the US and Europe at the World Congress event, Rare Disease Economics and Orphan Drug Commercialization, that is being held in Boston, MA, 22-23 September.

To read more and to register click here


Dr Thomas Lönngren






Dr. Thomas Lönngren, Strategic Advisor NDA Group 

Adaptive licensing and expedited pathways

By Johan Strömquist

A version of this article by NDA CEO Johan Strömquist on the development of novel regulatory pathways such as the FDA breakthrough designation and the EMA adaptive licensing concept, was published in the May issue of MedNous.

Drug development has become an increasingly timeconsuming and costly exercise. In fact, the cost of new medicines is continuing to escalate just as the public is becoming more aware of the need to have new agents to treat serious diseases. The pressure is therefore on to find new ways to deliver innovation – and to deliver it efficiently.

The drug regulator stands in a pivotal position in this debate. Regulators have a legal responsibility to protect the public health by making sure that new medicines meet rigorous standards of safety and efficacy both before and after market launch. Recently, both the European Medicines Agency and the Food and Drug Administration have been employing some vision to try and facilitate innovation as well. Thus far, the US has been the most pro-active.

In July 2012 the FDA introduced a new regulatory pathway called the ‘breakthrough therapy designation’ that builds on a pre-existing pathway called the ‘fast track designation.’ Both pathways allow the faster review of products with a potential for treating serious or life-threatening conditions. Of the two, the breakthrough designation is clearly targeted at innovation.

In order to obtain breakthrough status, a company must provide preliminary clinical evidence that its drug may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoint, such as showing substantial effects of treatment during clinical development. Similarly fast track designation is intended for drugs that would fill an unmet medical need.

However fast track drugs need only show some advantage over available therapies – not the substantial improvement required for breakthrough designation. This is a subtle but important difference.

Relevant links




Interchangeability. An insurmountable fifth hurdle?

NDA Advisory Board member, Paul Chamberlain, has just had an article, written in collaboration with Dr Hans Ebbers (University of Utrecht, The Netherlands) published in Generics and Biosimilars Initiative Journal (GaBI Journal):

“Interchangeability. An insurmountable fifth hurdle?”

This article questions whether designation of biosimilar products as “interchangeable” is a feasible objective in the sense where this would allow automatic substitution at the pharmacy level. Arguably, the burden of demonstrating continuing biosimilarity in the post-approval setting could outweigh the potential cost benefits to the public healthcare system.









Paul Chamberlain, NDA Group Biopharmaceuticals Expert and NDA Advisory Board member

Making Progress with Biosimilars

NDA Group’s Dr Gopalan Narayanan has published an article in EBR magazine addressing the market for biosimilars as a lower-cost alternative. Biosimilars were originally eyed with suspicion by several stakeholders when introduced in the EU in 2004. Since then, there has been increasing global recognition of their value, with the first monoclonal antibody being approved in 2013 in the EU.

Dr Gopalan Narayanan has over 15 years’ combined experience within the biologics and biotech industry at the MHRA as Head of Biologicals Unit and as an Expert Medical Assessor, and at Chiron as an Associate Medical Director. Gopalan is qualified as a doctor and is a post-graduate in General Internal Medicine and Pharmaceutical Medicine.




Gopalan Narayanan






Gopalan Narayanan, Biologics and Advanced Therapies expert NDA Group

Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway

NDA Advisory Board member, Paul Chamberlain, has just had an article published in Biosimilars magazine. The article is titled:

“Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway’.

The article comprehensively reviews the weight of evidence for EU approval of biosimilar products, including clinical, non-clinical, product quality and bioanalytical aspects. Unresolved questions concerning the limitations of post-marketing data to assure continuing biosimilarity, potential immunogenicity-related risks associated with switching medications, interchangeability and substitution are also discussed.

Read the full article here









Paul Chamberlain, NDA Group Biopharmaceuticals Expert and NDA Advisory Board member

Dr Pieter Neels attends WHO Vaccine Consultations

Dr Pieter Neels, a member of NDAs Regulatory Advisory Board, is attending two World Health Organisation (WHO) Vaccine Consultations in July as a regulatory expert in this field.

The first is on ‘influenza vaccines for pregnant and lactating women: Clinical data requirements for product labelling and labelling rule changes’. It is being held on 15-16 July 2014 at the WHO HQ in Geneva, Switzerland.

The second Consultation is an ‘Update To Guidelines For National Regulatory Agencies and Vaccine Manufacturers on Clinical Evaluation of Vaccines’. This is being held on 17-18 July, also at the WHO HQ.

Dr Neels is an EU regulatory expert on vaccines and he is asked by WHO for his expertise in this field. He is invited on many occasions to attend and provide his viewpoint in their vaccine meetings, in order to try to help them with guidance on how vaccines should be developed and registered in the world. However, having after licensed the vaccine, the implementation might be a problem as not all circumstances are foreseen in the labelling, and so finding the right way forward is part of these discussions.








Dr. Pieter Neels, NDA Group Clinical Expert and Advisory Board member

Rosalind Cox awarded TOPRA fellowship

Rosalind Cox, Scientific Adviser and Principal Consultant NDA Group, has recently been elected ‘Fellow of TOPRA’, in recognition of her commitment and service to the regulatory affairs profession.

Fellowship is awarded to TOPRA members who have at least 10 years’ experience in regulatory affairs, and made a significant contribution throughout their career to the industry. The award is also intended to reinforce the way that senior regulatory professionals can utilise their experience and knowledge in order to influence and guide their colleagues and the profession as a whole.

You can read this news in the May edition of TOPRA-InTouch-Newsletter.







Rosalind Cox, Scientific Adviser and Principal Consultant NDA Group