Robert Kronqvist joins NDA Group as General Manager Nordics

Robert Kronqvist joins NDA Group as General Manager Nordics


 

We are happy to announce and welcome Robert Kronqvist to the NDA team as General Manager for our Nordic affiliate head-quartered in Stockholm, Sweden. Robert brings with him 20 years’ experience from working in the Nordic Life Science Sector.

Working in both large pharma and as the CEO of a smaller biotech has provided Robert with invaluable insights into the industry, allowing him to help NDA’s clients overcome the hurdles of developing and getting novel products to market.

“I am thrilled to join the NDA Group with its strong track record of delivering value to clients” says Robert. “The Nordic innovation and Life Science community is thriving, and I am looking forward not only to supporting our existing clients but also reaching out to new and emerging Biotech companies here in the Nordics and helping them to bring their innovative products to the market with minimal delay.”

As the new General Manager for the Nordics, Robert will be responsible for developing, managing and driving the NDA team and business in the region. With his network and skills NDA’s capabilities will become more available and easier to access to large and small companies alike, than ever before.

“I’m very excited to have Robert join our team” commented Johan Strömquist, CEO of NDA Group. “His sense of focus, pragmatism and long experience from industry will enable us to engage with our clients and their challenges in new and more flexible ways.”

Robert started his career in biochemistry research that he continued at AstraZeneca. There he rapidly took on increased responsibilities and became a trusted leader within CNS & Pain R&D. His main focus was pre-clinical activities and supporting his teams through times of change.

At the close of AstraZeneca’s site in Södertälje Robert stepped in as CEO for BioChromix, one of the companies supported by Karolinska Development.

Since then Robert has both helped the Swedish Police authority develop their processes and practices for DNA analysis for forensics purposes as the head of the biology section and six teams of over 100 staff, and most recently as Director Analytical Development & Head of Quality control at RISE Research Institutes of Sweden.

“Robert’s experience provides us with a great opportunity to expand our reach in the Nordic market and for more clients to discover the many services and options that we have to offer to accelerate their drug development activities” continues Johan Strömquist. “Robert’s background gives our clients the ideal counterpart in NDA, with a thorough understanding of the situation and challenges that they are going through.”

If you would like to know more about our services in the Nordics contact us at info@ndareg.com or  contact Robert direct at  robert.kronqvist@ndareg.com

 

 

 

Passionate about solutions for patients with rare diseases

 

1 in 20 people will live with rare disease at some time in their life*.

Johan Strömquist CEO NDA says: “There are more than 6 000 identified, untreated rare diseases in the world. A lot has been done in recent years to address this by regulators and innovators but for many it is still not enough.”

At NDA much of the work we do go into supporting companies working to address this. We care passionately about this work and about getting treatments to the patients affected. Rare Disease Day is our opportunity to show this to the world and to promote the vital work that is going on in this space by so many passionate patients, physicians and scientists.


What is Rare Disease Day?

Rare Disease Day was first launched by Eurordis and its Council of National Alliances in 2008 with the goal to raise awareness amongst the general public and decision-makers about rare diseases and their impact on patients’ lives. 1 in 20 people will live with rare disease at some time in their life but despite this there is no cure for the majority of rare diseases and many go undiagnosed.

For 20 years the NDA Group has supported pharmaceutical and biotech companies around the world with strategic regulatory guidance across a range of diseases. Increasingly more companies have been trying to solve the puzzles for a diversity of untreated rare diseases. NDA has been there every step of the way.

Laurie Smaldone Alsup, MD, CSO and CMO of NDA says: “I believe we are still at the beginning of addressing rare diseases. With new scientific and technical advances every day we will be turning a corner where many more novel treatments will be discovered to address a range of difficult to treat disorders.”

She continues: “For me Rare disease day is a call to arms to create awareness of the continued need to address serious rare disorders to improve and extend patients’ lives.”

The theme of 2019 – Bridging health and social care

The theme for this 2019 Rare Disease Day is ‘Bridging health and social care’ For most people living with a rare disease, as well as their family members or carers, the reality of daily life can include any combination of the following: collecting and taking medicines, attending appointments, participating in physical therapy, using specialist equipment and accessing various social and community support services and respite care. Managing these care-related tasks alongside their usual daily activities such as work, school and leisure time can be challenging.

In support of patients with rare disease

2018 Rare Disease Day theme, ‘Patient Involvement in Research’, helped to underpin the importance of including patients in the drug development process.

Dr. Markku Toivonen, MD, Scientific Director at NDA, former CHMP member and Chairman of EMA’s Scientific Advice Working Party comments:
“The development of patient advocacy and the involvement of patients in the development and regulatory process has truly been game changing. At NDA we take great pride in helping to empower patient advocates through training in regulatory science and medical research with Eurordis, the European Organisation for Rare Diseases. ”

Markku continues: “Personally, it has been a privilege to participate in Eurordis Summer School for patient experts, advocates and researchers annually over the past 10 years as one of the trainers. Based on the candid feedback Eurordis has received over the years, the enthusiastic and highly motivated participants with varied backgrounds have benefited from the interactions with peers. They have returned home with new tools to help them in their endeavors and to navigate in the maze of science, medicines development, licensing and real-world challenges. It has been a pleasure to meet many of them again over the years, and to see how they have contributed at various levels from new medicinal product development to regulatory authority activities and overcoming the ultimate hurdle: access to treatment.”

* www.rarediseaseday.org

 

 

Seasoned drug development professional Kim Forbes-McKean PhD to lead NDA Group’s US expansion

Kim Forbes-McKean PhD, joins NDA Group from a distinguished career spanning more than 30 years of leading research and development activities for large pharma, as well as small biotech companies.


“Kim brings with her tremendous experience of the challenges facing development companies all over the world,” commented Johan Strömquist, CEO NDA Group.
“I am very happy and proud to have her join the NDA Group management team to further expand our activities in the US and I believe her expertise and experience will be of great value to our clients.”

Prior to joining NDA Kim was responsible for worldwide development of dermatology products at various companies including, Rhône-Poulenc Rorer, Aventis-Sanofi and Aqua Almirall, overseeing seven successful regulatory approvals and product launches.

She co-founded a dermatological development company and has been an executive member of management teams who have successfully raised over $90 million to support business development, licensing objectives and drug development activities which lead to partnering or acquisition opportunities.

Kim has built and led teams across all phases of development to advance global drug and device programs as well as for support and maintenance of commercial products. She has extensive experience and has served as a company representative directly interacting with the FDA throughout the development and approval process.

“In Kim, not only do we have an accomplished scientist and strategic regulatory thinker, but an experienced business professional who has been in our clients’ shoes,” commented Laurie Smaldone-Alsup, CSO/CMO NDA Group. “Kim understands the pressures and priorities of large pharma as well as small biotechs and the trade-offs facing CEOs and drug development executives on a daily basis. I am delighted to welcome her to our team. “


About NDA
NDA is an independent consulting group with offices in Stockholm, London, Zürich, Munich, Paris, 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. www.ndareg.com

NDA media contact:
anna.perrin@ndareg.com

 

 

 

NDA Group further expands their Advisory Board

Dr Patrick Salmon former Senior Medical Assessor at the Irish Medicines Board has joined NDA Advisory Board.


Dr Salmon is an expert in clinical development, strategies and a specialist in pharmaceutical medicine, with almost 25 years regulatory experience at both national and EU level.

His in depth regulatory expertise in rare diseases and other special therapeutic areas such as ophthalmology and the interrelated working of EMA’s committees and the CMDh will be a superb asset to the Advisory Board.

Dr Werner Van den Eynde, Vice President NDA Advisory Board, commented on the appointment:

“I’m very happy to welcome Dr Patrick Salmon on board as our newest Advisory Board Member. His expertise in regulatory affairs, clinical development and orphan medicinal products will be of tremendous value to our clients, enabling us to help them succeed in bringing their new medicinal products to the market”.

His previous roles include: Former Senior Medical Assessor at the Irish Medicines Board, (the Health Products Regulatory Authority), Committee for Human Medicinal Products Member (previously CPMP), Ireland, Committee for Orphan Medicinal Products Member Ireland, chair of CHMP ad hoc SmPC working party, chair of CMD(h) subgroup on SmPC Harmonisation and chair of working Group on Radiopharmaceuticals.

Dr Salmon has joined and is now part of the NDA Advisory Board, a unique team of experts comprising some of the most well-known names in the industry, many of whom have been involved in designing the regulatory and HTA systems in place today. Together, they provide strategic advice and unbiased second opinions to pharmaceutical clients during part of, or the complete end-to-end drug development life cycle. This also includes support and advice during interaction with regulatory agencies, be it at scientific advice, during review of a marketing authorisation application or at any stage post-authorisation

 


NDA media contact: anna.perrin@ndareg.com

About NDA
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. www.ndareg.com

 

 

NDA Group expands presence in Denmark

In time for the European BIO meeting in Copenhagen, global development consultancy, NDA Group, is expanding the physical presence in Denmark. With the appointment of Katja Gustafsson as Senior Consultant the company will be working closely with clients in the region. The news follows several recent announcements of the company’s expansions in Europe and the US.


Katja is joining NDA’s Professor Steffen Thirstrup, Director of NDA’s regulatory Advisory Board in Copenhagen.

Johan Strömquist, CEO of NDA Group commented: “We’re delighted to be joined by Katja in Copenhagen, further reinforcing our commitment to Nordic life science and the incredible development that we see in the Medicon Valley region. Even though the Nordics is the cradle of NDA and we’ve had a strong presence in the market through our Stockholm office, there is nothing like having feet on the ground when it comes to serving our clients.”

Consultant and client interface

In her role as Senior Consultant, Katja will work closely with companies in the Copenhagen / Malmö / Lund region and act as client liaison, in addition to serving the need for professional regulatory development advice. Together with Prof. Thirstrup, Katja will ensure that the region’s clients gain access to the wealth of intelligence, advice and support represented by the capabilities of the NDA Group. Both Katja and Prof. Thirstrup will be available to meet with companies at the BIO Europe meeting in Copenhagen 5th– 7th November.

Prof. Thirstrup commented: “Copenhagen is my home and I’m delighted to see the vibrant activity in the region. With the expansion of NDA’s capabilities in Denmark we will be able to support the region even better in its growth and innovation. This can only be good news for patients.”
Katja joins NDA from Ferring Pharmaceuticals, where she has spent the last 18 years in different roles in Global Regulatory Affairs. Her previous role was as Associate Director in Life Cycle Management and Urology. Katja has been regulatory lead and team member for several development projects and driving global submissions and approvals for various pharmaceutical products. She has a MSc (Pharm) from the Royal Danish School of Pharmacy.

Margareta Busk, General Manager, NDA Nordics commented: ”Katja’s energy, professionalism and long international experience will be a great asset for the NDA team as well as for our clients. We are very much looking forward to continuing our expansion in the Medicon Valley with her support.”


NDA media contact: anna.perrin@ndareg.com

About NDA
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. www.ndareg.com

 

 

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.

Are you ready for new EudraVigilance requirements?

Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group, has been invited to give a training on Signal Detection Management at Ramada Apollo, Amsterdam Centre, 20 – 21 September 2018.

Key topics that Shelley will cover:

  • Signal Detection Methods Qualitative vs. quantitative assessment of ICSRs
  • Finding a balance between efficiency and ensuring no safety signals go unnoticed
  • Signal Prioritisation differences between small, medium and big pharma
  • Regulatory and Industry Requirements and Standards
  • Quality system requirements: ensuring compliance and identifying gaps
  • New EudraVigilance requirements

Reasons to attend:

  • Get a comprehensive understanding of signal detection strategies
  • Improve and maintain your audit trail
  • Learn about current and future trends in signal collection
  • Hands-On case studies from the trainer‘s experience

To find out more about the event click here.


 

The future of Health Technology Assessment in Europe – Free Seminar

On the 24th October NDA Group invites you and your colleagues in the market access department/HEOR to a complimentary seminar on the future of HTA.

The market access environment is getting increasingly challenging. The ability to develop plans and strategies for access, for today as well as tomorrow, is critical to bring new medicines to patients.

With 17 years as Executive Director for NICE, Carole Longson has unparalleled experience in understanding how HTA bodies work and collaborate in the EU. In June 2018 she joined NDA as a HTA Advisor.

This seminar will discuss the past, present and future of HTA and market access. On stage Carole is joined by an esteemed panel comprising Professor Steffen Thirstrup, former Division Head at the Danish Medicines Agency and CHMP member, Dr Fredrik Andersson, Senior Director Global HEOR Ferring, Claes Buxfeldt former Global Director of Pricing and Reimbursement at AstraZeneca and Mark Aalgren, Senior Director Market Access and Public Affairs, ALK.

Date: 24 October 2018

Time: 8:30 – 12:00

Ask the Experts: 12:00 – 14:00 – Book a 20 min slot for a chat directly with our experts by contacting Rachel.stonebridge@ndareg.com.

Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15 , 2300 Ørestad City, Copenhagen, Denmark, Ground floor

SIGN UP


Agenda

8:30
Registration and light breakfast

9:00
Welcome
Claes Buxfeldt, HTA Director, NDA Advisory Services Ltd

Session 1 – Challenges on development programs for new drugs
Professor Steffen Thirstrup, Director, NDA Regulatory Advisory Board (previous Danish Medicines Agency / EMA)

  • Clinical trial guidelines and how to deliver patient centric critical data for regulatory and HTA bodies. Implications and mitigations.

10:15
Coffee break

10:45
Session 2 – HTA alignment in Europe – what does the future of HTA have in store?
Professor Carole Longson, Life Science Policy, Research and Market Access, NDA Advisory Services Ltd (previous executive Director NICE UK)

Conversation leaders at stage:

Claes Buxfeldt, HTA Director, NDA Advisory Services Ltd
Professor Steffen Thirstrup, Director, NDA Regulatory Advisory Board, NDA Advisory Services Ltd
Dr Fredrik Andersson, Senior Dir Global HEOR, Ferring
Mark Aalgren, Senior Director Market Access and Public Affairs, ALK

  • EU clinical effectiveness review (Parliaments proposal), where is it going? Will EU get a ‘super-HTA body’ in the future?
  • EUnetHTA and EMA, directions and implications for future collaborations
  • NICE after Brexit?

12:00
End of meeting – conclusions and take-home messages
Claes Buxfeldt, HTA Director, NDA Advisory Services Ltd

12:00 – 14:00
Ask the experts
Please ask for a 20 min slot for a chat directly with our experts by contacting rachel.stonebridge@ndareg.com

 

Carole Longson
Claes Buxfeldt
Steffen Thirstrup

 

 

 

 

 

 

Looking forward seeing you at the event!

 


 

Mark Goldberger, MD, MPH Infectious Disease Expert has joined the NDA Advisory Board

We are pleased to announced the expansion of the unique NDA Advisory Board with the appointment of Dr Mark Goldberger, Infectious Disease Expert.


Mark brings with him a wealth of experience in and in-depth knowledge of infectious diseases and antimicrobial products as well as extensive FDA expertise. For the clients of the reputable drug development consultancy this means high calibre advice to move such products swiftly through development and to regulatory success.

Dr Goldberger has unparalleled insight in these fields, working at the FDA as an expert within the Center for Drug Evaluation and Research (CDER), for which he held various roles of increasing responsibility, including five years as the Director of the Office of Antimicrobial Products. He also spent one year in the Center for Biologics Evaluation and Research (CBER) as Medical Director for Emerging and Pandemic Threat Preparedness.

Following his time at the FDA, Mark joined Abbott as Divisional Vice President involved in multiple areas of both product and policy development, before becoming VP Regulatory Affairs and Senior Advisor following the AbbVie split, providing both regulatory and scientific input into multiple development programs.

Mark is board certified in internal medicine and infectious disease and is a fellow of the Infectious Diseases Society of America.

Dr Werner Van den Eynde, Vice President NDA Advisory Board, commented on the appointment:
”The NDA Advisory Board is one of a kind – no other professional body comes as close to reflecting the current opinions and practices of the world’s regulatory and reimbursement agencies. I am very excited to welcome Dr. Goldberger on board. With his in-depth knowledge of infectious diseases and antimicrobial products as well as his FDA experience he will be able to add tremendous value to clients in these areas and help them to make new and promising medicines available to patients.”

Dr Goldberger is joining an increasing number of former FDA thought leaders at NDA, who since announcing its expansion into the US in 2016, has grown a team of more than 30 regulatory, drug development and scientific communications specialists in their locations in Boston, Princeton and San Francisco.


NDA media contact: anna.perrin@ndareg.com

About NDA
NDA is an independent consulting group with offices in Stockholm, London, Zürich, Munich, Paris, 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. www.ndareg.com

Paula Salmikangas presents on Regulatory and scientific challenges for global development

Dr Paula Salmikangas, Director for Biopharmaceuticals and ATMPS, NDA Advisory Board, has been invited to present at the World Advanced Therapies and Regenerative Medicine Congress, 16 – 18 May, Business Design Centre, London.

Dr Salmikangas will speak in the Plenary Round Table Discussion Session: Process Development & Manufacturing Focus, with the topic title: Regulatory and scientific challenges for global development.

At this event you will have the opportunity to Research, Develop, Collaborate & Commercialise.

  • Meet 600 industry leaders from the pharma, biotech and research industry
  • Take part in 20 free seminars focusing on human application for stem cells, bioelectronic medicine, investment for AI in Healthcare and more!
  • Discover and experience the latest and most innovative products and solutions in the market showcased by 50 industry leaders
  • Be inspired by industry thought leaders during live interviews conducted on the exhibition floor
  • Discover the companies of the future in our innovation zone

 

Click here to find out more about the event.


 

Professor Carole Longson to join NDA as Scientific Adviser

Carole Longson MBE, former Executive Director and Board member at the National Institute for Health and Care Excellence (NICE), has joined the NDA Advisory Board. Carole will act as an adviser within NDA on matters relating to drug approval, scientific advice and Health Technology Assessments, areas in which she has had great impact in her previous role.


Carole brings tremendous research, academic and pharmaceutical industry experience to the role, including seven years as a Research Lead at GlaxoSmithKline R&D.

She has extensive expertise of directing multidisciplinary life sciences research programmes, managing large scientific departments and collaborating on multinational research grants.

Carole was a past member of the Scientific Advisory Committee for Innovative Medicines Initiative (IMI), the leading pan-European public- private partnership which funds health research and innovation. She also holds non-Executive Director and advisory roles in other scientific organisations in the UK and abroad. These positions give her a unique and extensive perspective on the changing face of industry.

Carole has unparalleled insight into the fast evolving medicines pipeline having spent the past 18 years at NICE where she has pioneered and led the organisation’s technology appraisal programme. Carole is highly respected as a leader in HTA & Market Access, both in the UK and internationally and was formerly President of Health Technology Assessment International.

Throughout her career and role at NICE, Carole has gained valuable understanding of how the public and private sector must continue to collaborate to meet the shared aims of ensuring medical innovation benefits patients in the UK.

Johan Strömquist, CEO NDA Group, commented on the appointment:
“I am delighted to see Carole join us. Not only will she bring a wealth of knowledge and experience to NDA that fits intimately with our strategic direction, her reputation in the industry and among her former Agency peers, also stems from her positive and collaborative personality.”

Werner Van den Eynde, Vice President NDA Advisory Services, commented:
“This appointment is a major step in our continuing aim to broaden our reach and expand HTA and market aspects into our drug development service offerings. It is also a testament to NDAs reputation amongst regulators and HTA bodies – NDA remains the undisputed prime destination for the greatest contributors to our regulatory and assessment systems.”


NDA media contact: anna.perrin@ndareg.com

About NDA
NDA is an independent consulting group with offices in Stockholm, London, Zürich, Munich, Paris, 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. www.ndareg.com

 

 

Free Webinar – Rational EU risk management for oncology medicines: time for a rethink

It is timely to reflect on how we can best implement the revised GVP module (V) concerning risk management in the interests of patients throughout the life-cycle of a medicine.

Join us on Thursday, 24th May to hear NDAs Dr. Bill Richardson, Medical Advisor, discuss factors to consider include:

  • Taking into account the needs of the prescriber and other healthcare professionals
  • Applying the resources of the marketing authorisation holder (MAH) effectively to comply with regulatory expectation
  • Ensuring risk management plans reflect only measures that MAHs can reasonably control while retaining the MAH’s duty of care
  • Remembering risk management during clinical development is intrinsic to Good Clinical Practice
  • Providing precise instructions for minimising risk in the protocol and investigator brochure to form the basis of the EU risk management plan
  • Designing pivotal studies based on the anticipated target group once marketed
  • Defining recommended conditions for safe and effective use of a medicine to minimise risk

Thus, how can we now sensibly apply the revised GVP module for risk management?

Dr. Richardson is an experienced ex-EU regulator who understands the detail by which a typical RMP will be assessed and who will provide practical guidance to help you produce compliant RMPs effectively and efficiently.

Click here to book your place today.


 

Dr. Bill Richardson qualified in medicine in 1980, and subsequently trained as an anaesthetist. He has over 25 years of regulatory affairs and pharmaceutical medicine experience, from clinical development to post-marketing. He joined NDA Group in 2014 after having worked for 11 years as a medical assessor at the UK medicines’ regulator (MHRA). He is an expert in pharmacovigilance and risk management – risk:benefit evaluation, risk management planning and scientific advice in the context of the current EU pharmacovigilance legislation, including the role of the QPPV. He has considerable expertise in the following areas:

  • Clinical development and clinical safety of medicines delivered by inhalation, particularly medicines for asthma and chronic obstructive pulmonary disease.
  • Clinical assessment of drug safety aspects of marketing authorisation applications in a wide range of therapeutic areas particularly: immunosuppressants including TNF inhibitors; epoetins; biosimilar products; oncology products including thalidomide and analogues, protein kinase inhibitors, and vascular endothelial growth factor (VEGF) inhibitors; anaesthetic agents/ICU medicines.
  • Assessment of new drugs, biologics, generics and EU safety referrals and major changes to marketing authorisations.
  • Training in pharmacovigilance particularly risk: benefit evaluation

 

Is a global regulatory and market access strategy the way to go?

Dr. Thomas Lönngren, Strategic Advisor to NDA Group and former Executive Director of the European Medicines Agency (EMA), has been invited to present at the Chief Medical Officer Summit, Omni Parker House, Boston, MA on 7th May.


Thomas will present along with Jeffrey Sherman, CMO, EVP R&D, Horizon Pharmaceuticals, in the session ‘Taking a Strategy Approach to Global Regulatory and Market Access Challenges’, were they will discuss:

  • Is a global regulatory and market access strategy the way to go?
  • Why isn’t EMA approval the same as market access in Europe?
  • What is the difference between EMA and FDA in regulating and approving medicines?
  • When and how to generate evidence that will satisfy regulators and payers
  • What is the best strategy to interact with regulators and payers?
  • Early access schemes in EU and how to qualify
  • How will trends like Real World Evidence influence regulatory decision making?
  • Brexit and its consequences for the EU regulatory system and how will it affect pharmaceutical companies

As well as presenting at the event, NDA Group is ‘Associate Sponsor’ of the CMO Summits, demonstrating its commitment and support towards the CMO community.

Please come by booth #2 and meet us;

  • Dr. Thomas Lönngren, Strategic Advisor to NDA Group and former Executive Director of the EMA
  • Laurie Smaldone-Alsup, MD, COO/CSO
  • Barbara Clendenen, Director, Business Development

The CMO conference is an annual gathering for physicians and scientists in biotech to exchange best practices in the advancement of drug development and business management. Although the program is primarily designed for CMOs of emerging biotech companies, CMOs of large pharma and other R&D decision-makers will also benefit.

To find out more about the event click here.


 

 

Meet us at PEGS Boston


 

NDA Group will be attending PEGS Boston, that takes place in Seaport World Trade Center, Boston April 30 – May 4, 2018

NDA supported over 40% of the new medicinal products that were approved in the EU during 2013 -2017. In 2016 NDA acquired PharmApprove, the market leader in managing critical FDA interactions to help us achieve the same results in the US.

If you are planning to attend this year’s PEGS, we would really like to meet up with you. We will have a few of our experts available at the event at booth 437:

  • Dr Niamh Kinsella, Biologics Expert
  • Dr Jenny Sims, Non Clinical Expert
  • Dr Josefin-Beate Holz, Clinical Strategy Expert

If you would like to arrange a meeting, please contact Niamh Kinsella, who will be happy to assist, niamh.kinsella@ndareg.com

 

Presentations

Three of our experts will present at the event:

Jenny Sims:

Monday 30th April 12.20 pm, Immunogenicity Case Studies and Clinical Management Track.
Title: Early Development Strategy for Bacterial- or Viral-Vectored Gene Therapies: 2 Case Studies

 

 

Josefin-Beate Holz
Monday 30th April and Tuesday 1st May, Poster Session A
Developing an Integrated Summary of Immunogenicity (ISI) to Effectively Manage Regulatory Risks in Product Development

 

 

 

Niamh Kinsella
Wednesday 2nd May and Thursday 3rd May, Poster Session B
Maximising Value in Early Development

 

 

 

 

Click here to find out more about the event.

We look forward to hearing back from you about a meeting and to seeing you at the event!