Future of clinical trials, AI and data

Our Conference on Future of clinical trials, AI and data is coming up and you are kindly invited to book the date in your calendar:

Friday, 25 September 2020

Sofia, Bulgaria (online event)

Summary

We are witnessing a biotechnological revolution and more companies invest huge funds in the biotechnology industry. Biotechnologies are at the heart of cancer and rare diseases therapies and they offer tailored treatment which is more beneficial for the patient. We will be discussing the state of clinical trials in biotechnology in Bulgaria and Romania, regulatory burden, investment, lack of expert personnel, public attitude, other challenges as well as achievements. Machine learning, artificial intelligence (AI), patients’ data processing and its reliable storage will be also considered. Speakers from the UK will showcase the UK experience and best practices. The event will serve as an opportunity to extend already established UK-Bulgarian links in biotechnology towards clinical trials, as well as develop new commercial opportunities in this sector. Romanian partners will be also introduced and thus a sustainable business network between the UK and East Europe will be established.

Topics

UK, Bulgarian and Romanian decision makers, academics and companies will discuss the latest regulations, tendencies and innovative research in clinical trials such as:

  • Importance of developing clinical trials – real benefit for patients and physicians
  • Developments and challenges in Bulgaria and Romania (regulatory, scientific and operational challenges)
  • UK experience and best practices in clinical trials (regulations, research)
  • Patient data handling, GDPR and regulatory compliance
  • Artificial Intelligence (AI) and machine learning in clinical trials
  • European legislation in clinical trials
  • Crisis situations (like Covid19) – calls for new approaches and quick actions

Objectives of the conference

  • to showcase the UK experience and best practices,
  • exchange information and practicalities on the UK, Bulgarian and Romanian legislation in clinical trials,
  • establishing collaborations of the UK with innovative East European opportunities (on business/academic/decision maker side).

Agenda

All times are in Eastern European Summer Time (EEST) / UTC +3

11:00
 – 11:10

Welcome and opening

Lynne Charles, UK Deputy Ambassador to Bulgaria
Emilia Pecheva, SIN officer for Bulgaria and Romania

Setting the scene: Future of clinical trials - what it would be?

Chair: Cristina Florescu Moraid

11:10
 – 11:15

Setting the scene: Future of clinical trials - what it would be?

Chair
Cristina Florescu Moraid

11:15
 – 11:30

Research transparency, public involvement and proportionality of ethical review

Naho Yamazaki

11:30
 – 11:45

Clinical Research Landscape in Bulgaria – From Status Quo toward Status GO!

Assoc. Prof. Dr. Borislav Borisov

11:45
 – 12:00

Activities of the Ethics Committee for Clinical Trials in Bulgaria to meet the challenges of the new regulatory requirements in the EU and to improve the environment for conducting clinical trials in Bulgaria

Boyan Doganov

12:00
 – 12:15

Clinical Trials market & Financial impact – Global overview

Catalina Sarbu

12:15
 – 12:30

Scientific evidence based ethical assessment. Future objectives of national ethics committee.

Constantin Mircioiu

12:30
 – 13:00

Discussion

Open discussion with questions and comments from the floor

13:00
 – 13:30

Break

Digital, AI and data

Chair: Marius Geanta

13:30
 – 13:45

The lack of data as an obstacle to the clinical trials development in CEE

Maya Zlatanova

13:45
 – 14:00

Using AI to generate Real World Evidence (RWE)

Alex Blakoe

14:00
 – 14:15

Patient-centric software powering decentralised trials

Bruce Hellman

14:15
 – 14:30

Decentralised clinical trials: moving from nicety to necessity

Elin Haf Davies

14:30
 – 14:45

High level overview of several digital innovations and technologies that help advance healthcare research and clinical care

Leon Van Wouwe

14:45
 – 15:00

Patient First: changing the clinical trials paradigm

Magda Chlebus

15:00
 – 15:10

Q&A

Questions and comments from the floor

15:10
 – 15:20

Break

Research and patients

Chair: Borislav Borisov

15:20
 – 15:35

NIHR Clinical Research Network: the delivery arm of the NHS

Sarah Cooper

15:35
 – 15:50

How to embed research in a national health service

David Rowbotham

15:50
 – 16:05

Clinical Trials in Bulgaria – Key Challenges

Kamen Doxev

16:05
 – 16:20

Sleep disorders and clinical trials: new challenges and perspectives

Prof. Dr. Ivan Staikov
Nikolay Mihnev

16:20
 – 16:35

At a time of a global pandemic we recognize more than ever the need for clinical research- key note on the importance, benefits and socio-economic impact of clinical trials

Cristina Florescu Moraid

16:35
 – 16:50

Romanian clinical trials market - huge potential suffocated by lack of vision

Cristian Sas

16:50
 – 17:00

Break

17:00
 – 17:10

The importance of clinical research in saving patient’s life - academy point of view

Prof. Dr. Doina Draganescu

17:10
 – 17:25

Improved adverse event/medical error reporting

Dolores Cahill

17:25
 – 17:45

Discussion

Open discussion with questions and comments from the floor

17:45
 – 18:00

Conclusions and closure

Speakers

We expect representatives of the UK NIHR Clinical Research Network, Health Research Authority, The Academy of Medical Sciences, Medical Research Council – Clinical Trials Unit, the Bulgarian Association of Clinical Research and Ethics Committee for Clinical Trials, the Romanian National Agency for Drugs and Medical Devices and Ethics Commission, as well as number of companies, academics and patients from the three countries.

United Kingdom

Alex Blakoe

Chief Operating Office
Cievert

Belgium

Magda Chlebus

Executive Director Science policy & Regulatory affairs
EFPIA

United Kingdom

Sarah Cooper

Business Development Manager (Commercial)
National Institute for Health Research – Clinical Research Network

Bulgaria

Kamen Doxev, MD

Country Manager/Regional Director for Bulgaria, Greece, Turkey and Israel
PSI-CRO

Romania

Dr. Marius Geanta

Co-Founder & President
InnoMed center for Innovation in Medicine

Romania

Acad. Prof. Dr. Constantin Mircioiu

Vice-President of National Commission of Bioethics of Drugs and Medical Devices
President of Pharmaceutical Dept. Academy of Medical Sciences, Romania

United Kingdom

Prof David Rowbotham

Emeritus Professor of Anaesthesia and Pain Management, University of Leicester
Clinical Director, NIHR Clinical Research Network East Midlands

Romania

Dr Catalina Sarbu

Director Clinical Operations, Parexel International Romania
Head of the CRO Association in Romania (ACCSCR)

Romania

Cristian Sas

CEO
Sfanta Maria Clinics & Laboratory’s, MedLife Group

Bulgaria

Prof. Ivan Staikov

Head of the Clinic of Neurology and Sleep Medicine
Acibadem City Clinic Tokuda Hospital

United Kingdom

Naho Yamazaki

Director of Policy and Engagement
Health Research Authority

Bulgaria

Maya Zlatanova

CEO of FindMeCure
Product Master Mind @ TrialHub at FindMeCure

Audience

If you are involved in research, business or regulations of clinical trials, and are interested in participating, please register by 16 September – tick the square next to event “25/09 Future of Clinical Trials”.

The conference will be in English and no translation will be provided. The event is a follow-up of the Biotech Business workshop and the Intellectual Property & Technology Transfer training in Biotech organised by SIN Bulgaria in 2019.

Stay tuned for joining links coming soon!

Organisers
Menu