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)


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.


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).


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

 – 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

 – 11:15

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

Cristina Florescu Moraid

 – 11:30

Research transparency, public involvement and proportionality of ethical review

Naho Yamazaki

 – 11:45

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

Assoc. Prof. Dr. Borislav Borisov

 – 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

 – 12:15

Clinical Trials market & Financial impact – Global overview

Catalina Sarbu

 – 12:30

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

Constantin Mircioiu

 – 13:00


Open discussion with questions and comments from the floor

 – 13:30


Digital, AI and data

Chair: Marius Geanta

 – 13:45

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

Maya Zlatanova

 – 14:00

Using AI to generate Real World Evidence (RWE)

Alex Blakoe

 – 14:15

Patient-centric software powering decentralised trials

Bruce Hellman

 – 14:30

Decentralised clinical trials: moving from nicety to necessity

Elin Haf Davies

 – 14:45

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

Leon Van Wouwe

 – 15:00

Patient First: changing the clinical trials paradigm

Magda Chlebus

 – 15:10


Questions and comments from the floor

 – 15:20


Research and patients

Chair: Borislav Borisov

 – 15:35

NIHR Clinical Research Network: the delivery arm of the NHS

Sarah Cooper

 – 15:50

How to embed research in a national health service

David Rowbotham

 – 16:05

Clinical Trials in Bulgaria – Key Challenges

Kamen Doxev

 – 16:20

Sleep disorders and clinical trials: new challenges and perspectives

Prof. Dr. Ivan Staikov
Nikolay Mihnev

 – 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

 – 16:50

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

Cristian Sas

 – 17:00


 – 17:10

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

Prof. Dr. Doina Draganescu

 – 17:25

Improved adverse event/medical error reporting

Dolores Cahill

 – 17:45


Open discussion with questions and comments from the floor

 – 18:00

Conclusions and closure


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.

Alex Blakoe

United Kingdom

Alex Blakoe

Chief Operating Office
Magda Chlebus


Magda Chlebus

Executive Director Science policy & Regulatory affairs
Sarah Cooper

United Kingdom

Sarah Cooper

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


Kamen Doxev, MD

Country Manager/Regional Director for Bulgaria, Greece, Turkey and Israel
Dr. Marius Geanta


Dr. Marius Geanta

Co-Founder & President
InnoMed center for Innovation in Medicine
Constantin Mircioiu


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
David Rowbotham

United Kingdom

Prof David Rowbotham

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


Dr Catalina Sarbu

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


Cristian Sas

Sfanta Maria Clinics & Laboratory’s, MedLife Group
Prof. Ivan Staikov


Prof. Ivan Staikov

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

United Kingdom

Naho Yamazaki

Director of Policy and Engagement
Health Research Authority
Maya Zlatanova


Maya Zlatanova

CEO of FindMeCure
Product Master Mind @ TrialHub at FindMeCure


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!

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