CRA Akademija
CRA Akademija
“Clinical Trials Management – Challenges & Expectations”, December 12th, Belgrade
12th Regular Conference
“Clinical Trials Management – Challenges & Expectations”, April 14-15th 2022, Termag Hotel, Jahorina (Bosnia and Herzegovina), 1st Conference
„Clinical Trials Challenges“, December 9th 2021, Falkensteiner Hotel, Belgrade
11th Regular Conference
Program
This is the leading schooling program of its kind and the first established in the region. It was done in cooperation with leading pharmaceutical and CRO companies, but also lecturers of professional courses for clinical research.
I semester
Week 1: Introduction – the role of CRA in clinical trials
Week 2: Discovery and development of new pharmaceutical preparations
Week 3: Fundamentals of Clinical Pharmacology
In the first weeks of education, you will get acquainted in detail with the way of conducting clinical studies. You will be introduced to the life cycle of a drug; types of studies.
Week 4: Regulatory Basis of Clinical Research I
Week 5: Regulatory Basis of Clinical Research II
Clinical studies are strictly regulated by law. At the Academy you will learn all about the legal requirements for conducting clinical studies both at the local level and at the EU and US levels.
Week 6: Conducting clinical trials, general remarks
Introduction to general terms used in clinical studies.
Week 7: Ethics and documentation
Adherence to all ethical principles is crucial for conducting a clinical study. At the Academy, you will be introduced to the acts on which the ethics of testing new drugs is based.
Clinical studies require that everything is documented appropriately. Therefore, getting acquainted with the names, types and purpose of each document used during the study is necessary for conscientious and responsible work within the CRO company. After this lecture you will be able to clearly distinguish all the documents and sets of documents that confuse many employees.
Week 8: Good Clinical Practice – basics
Knowledge of ICH GCP is a requirement for every employee in the clinical study industry. GCP is an internacional, scientific and practical standard according to which all clinical studies are conducted.
Week 9: Monitoring I – Feasibility, Evaluation of the center
Week 10: Monitoring II – Initiation of the center, Monitoring of visits
Week 11: Monitoring III – Monitoring of visits, Close out of the center
Week 12: Monitoring IV – Finishing the study, archiving
Particular importance is attached to monitoring the progress of the clinical study and determining that the study is conducted, documented and reported in accordance with the prescribed protocol, standard operating procedures, principles of good clinical practice and legal requirements. This act is called monitoring and the person responsible for this function is the Clinical Research Associate (CRA).
The CRA Academy envisages 4 weeks of lectures related to monitor responsibilities as well as to explain how monitoring takes place. Lectures include preparation, implementation and reporting on monitoring visits. During the lecture you will be informed in detail about what is expected from the monitor.
II Semester
Week 1: Fraud and Misconduct; Audit and Inspection
Prevention, detection and resolution of any (un)intentional error, non-compliance and fraud of any member of the study implementation/ monitoring team is one of the crucial roles of the monitor – CRA. Our lecturers will present you the most common cases from practice as well as advice on how to act in a particular situation. Audit and inspection of the study are an integral part of one study. The auditor and inspector of the study are independent persons in charge of verifying the reliability of the collected data and determining the regularity of the study. The advice of the lecturers, who themselves work as Auditors, will help you prepare for this, for many a stressful process, and avoid all possible potential difficulties and complications.
Week 2: Basics of Project Management I
Week 3: Basics of Project Management II
The position of Project Manager requires previous work experience in the field of clinical studies. During the two – week lecture, the lecturer will instruct you in all the responsibilities and obligations of the person in this position. You will gain insight into the ways of organizing a team for monitoring a clinical study within a CRO company as well as the ways and methods for forming a study budget.
Week 4: Statistics and Data Processing I
Week 5: Statistics and Data Processing II
Statistics are needed to predict the potential number of patients who should participate in the study in order to obtain statistically significant data. Data collected during a clinical study must be subjected to statistical processing in order to be used for further development or registration of the drug. Statisticians also help create a randomization list – a list of assigning therapies to patients, in the case of randomized study.
Week 6: Recruiting patients
Patient enrollment is one of the main problems of any clinical study. Almost 30% of phase III studies are canceled or stopped due to difficulties in involving/recruiting patients. There are several ways to overcome this problem.
Week 7: Pharmacovigilance I
Week 8: Pharmacovigilance II and III
Monitoring of adverse events (AE) and suspected unexpected serious adverse drug reactions (SUSAR) is crucial and mandatory in a clinical study. It is the responsibility and obligation of each project employee to adequately deal with any adverse events during the study, which includes reporting to the sponsor and regulatory authorities to assess the event and determine its possible impact on the further course of the study. A lecturer with many years of experience in this field of clinical studies will present and explain the way pharmacovigilance works in clinical studies.
Week 9: Practical teaching
In order to ensure the safety and well-being of subjects and patients throughout the duration of the clinical trial as well as the validity of the data collected, the trials should be conducted in accordance with national and international standards. Over the past few years, regulations in the field of conducting clinical studies have become increasingly stringent, and that place greater demands on Investigators and investigators teams.
At the end of this education, you will be able to work as a Study Coordinator. The purpose of this education is to acquaint you with your study documentation and procedures, as well as to enable you to successfully perform your daily tasks.
This education is for health professionals acting under the supervision of the Principal Investigator (PI) / or the Sponsor / Clinical Research Organization (CRO) in order to conduct clinical research.
Monitoring is the act of monitoring the progress of a clinical trial and ensuring that it is conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP) and applicable regulatory requirements.
There are numerous tasks that a Monitor (CRA) must perform, which include selection, initiation, routine monitoring as well as closing centers through collaboration with the Principal Investigator and Investigators team, participating in organization and problem solving. There are a large number of regulations and guides that the Monitor (CRA) must follow during the performance of its daily duties.
During the education you will have the opportunity to gain theoretical knowledge that is permeated with practical experiences and tips for overcoming common problems that arise during everyday work. With the knowledge and skills gained during this education, you will meet all the requirements to be met by one Monitor (CRA).
Clinical trials are strictly regulated and must be conducted in accordance with standard ethical guidelines, codes of conduct and national laws, all for the purpose of ensuring patient safety, protecting human rights and privacy, and properly collecting data.
Through this education you will be introduced to key regulatory and guide requirements at both local and European Union level, including the new Clinical Trials Regulation and the existing Directive. You will also be introduced to the specific requirements of the United States.
The lecturers are experts from the Drug Agencies and employees with many years of experience in the CRO industry in regulatory affairs.
The focus of education is regulatory requirements for registered drugs. The Educators are mostly experts from the Drug Agencies and employees with many years of experience in the pharmaceutical industry in regulatory matters.
Pharmacovigilance is a set of activities related to the detection, assessment, understanding, prevention and treatment in case of adverse drug reactions, as well as new knowledge about the harmful effects of drug use.
During the education, you will be introduced to the method of monitoring the safety profile of medicines at the level of our country and countries at the region as well as at the level of the European Union. Reporting of individual adverse reactions, preparation of periodic reports, risk management, and introduction of risk reduction measures are just some of the topics that will be addressed during the education.
Good clinical practice is a framework of principles that ensure the safety of subjects in a clinical trial as well as the integrity and validity of the data collected. During this education you will be introduced to the practical application of these principles during the conduct of a clinical trial.
This education is intended for everyone who plans to start a career in the field of clinical studies, as well as for all employees in this industry in order to refresh their knowledge and be acquainted with the latest news in the field of clinical trials.
The training is based on the International ICH E6 (R2) Good Clinical Practice Guide. Also, this training is on the TransCelerate list, and after successfully completing the training you receive a certified diploma.
There is a Basic Level of Education (Basic GCP) and an Advanced Level of Education (Advanced GCP).
I semester
Week 1: Introduction – the role of CRA in clinical trials
Week 2: Discovery and development of new pharmaceutical preparations
Week 3: Fundamentals of Clinical Pharmacology
In the first weeks of education, you will get acquainted in detail with the way of conducting clinical studies. You will be introduced to the life cycle of a drug; types of studies.
Week 4: Regulatory Basis of Clinical Research I
Week 5: Regulatory Basis of Clinical Research II
Clinical studies are strictly regulated by law. At the Academy you will learn all about the legal requirements for conducting clinical studies both at the local level and at the EU and US levels.
Week 6: Conducting clinical trials, general remarks
Introduction to general terms used in clinical studies.
Week 7: Ethics and documentation
Adherence to all ethical principles is crucial for conducting a clinical study. At the Academy, you will be introduced to the acts on which the ethics of testing new drugs is based.
Clinical studies require that everything is documented appropriately. Therefore, getting acquainted with the names, types and purpose of each document used during the study is necessary for conscientious and responsible work within the CRO company. After this lecture you will be able to clearly distinguish all the documents and sets of documents that confuse many employees.
Week 8: Good Clinical Practice – basics
Knowledge of ICH GCP is a requirement for every employee in the clinical study industry. GCP is an internacional, scientific and practical standard according to which all clinical studies are conducted.
Week 9: Monitoring I – Feasibility, Evaluation of the center
Week 10: Monitoring II – Initiation of the center, Monitoring of visits
Week 11: Monitoring III – Monitoring of visits, Close out of the center
Week 12: Monitoring IV – Finishing the study, archiving
Particular importance is attached to monitoring the progress of the clinical study and determining that the study is conducted, documented and reported in accordance with the prescribed protocol, standard operating procedures, principles of good clinical practice and legal requirements. This act is called monitoring and the person responsible for this function is the Clinical Research Associate (CRA).
The CRA Academy envisages 4 weeks of lectures related to monitor responsibilities as well as to explain how monitoring takes place. Lectures include preparation, implementation and reporting on monitoring visits. During the lecture you will be informed in detail about what is expected from the monitor.
II Semester
Week 1: Fraud and Misconduct; Audit and Inspection
Prevention, detection and resolution of any (un)intentional error, non-compliance and fraud of any member of the study implementation/ monitoring team is one of the crucial roles of the monitor – CRA. Our lecturers will present you the most common cases from practice as well as advice on how to act in a particular situation. Audit and inspection of the study are an integral part of one study. The auditor and inspector of the study are independent persons in charge of verifying the reliability of the collected data and determining the regularity of the study. The advice of the lecturers, who themselves work as Auditors, will help you prepare for this, for many a stressful process, and avoid all possible potential difficulties and complications.
Week 2: Basics of Project Management I
Week 3: Basics of Project Management II
The position of Project Manager requires previous work experience in the field of clinical studies. During the two – week lecture, the lecturer will instruct you in all the responsibilities and obligations of the person in this position. You will gain insight into the ways of organizing a team for monitoring a clinical study within a CRO company as well as the ways and methods for forming a study budget.
Week 4: Statistics and Data Processing I
Week 5: Statistics and Data Processing II
Statistics are needed to predict the potential number of patients who should participate in the study in order to obtain statistically significant data. Data collected during a clinical study must be subjected to statistical processing in order to be used for further development or registration of the drug. Statisticians also help create a randomization list – a list of assigning therapies to patients, in the case of randomized study.
Week 6: Recruiting patients
Patient enrollment is one of the main problems of any clinical study. Almost 30% of phase III studies are canceled or stopped due to difficulties in involving/recruiting patients. There are several ways to overcome this problem.
Week 7: Pharmacovigilance I
Week 8: Pharmacovigilance II and III
Monitoring of adverse events (AE) and suspected unexpected serious adverse drug reactions (SUSAR) is crucial and mandatory in a clinical study. It is the responsibility and obligation of each project employee to adequately deal with any adverse events during the study, which includes reporting to the sponsor and regulatory authorities to assess the event and determine its possible impact on the further course of the study. A lecturer with many years of experience in this field of clinical studies will present and explain the way pharmacovigilance works in clinical studies.
Week 9: Practical teaching
MD PhD
Branislav Gvozdenović is a specialist in internal medicine. He holds a PhD in pulmonology from the University of Belgrade School of Medicine.
Three years of experience as a lecturer at the Department of postgraduate pulmonology studies, School of Medicine, Belgrade. Certified lecturer at CRA Academy in Belgrade.
Works in pharmaceutical and CRO industry since 1994. Serbia and Croatia Country Manager at PPD from 2006 – 2014.
Current position: Medical Director for Respiratory Diseases, since 2014.
Throughout clinical trial program development, Dr. Gvozdenovic provides medical consultation to clients and project team members, including the medical point of view as it relates to business development and marketing applications.
He is a Board-certified physician – specialist and Primarius in Internal Medicine. Acting as an internist-pulmonologist consultant for several private clinics in Belgrade, he takes care about the treatment and management of outpatients with respiratory diseases. He authored numerous scientific articles in the field of respiratory medicine.
Work experience in many different areas of pharmaceutical industry, clinical trials, public relations, translating.
Works in clinical trials since 1997.(Vujaklija CRO, Icon, Parexel, INC Research, PSR Group), pharmaceutical industry (Pfizer) as a CRA, Study Start Up, Medical Director, Managing Director, Medical Writer, GCP Trainer, Compliance Lead, Director Compliance Oversight, Clinical Research Consultant.Since 2004, a consultant for French Research Institute MAPI – linguistic validation of PRO (Patient Reported Outcomes).Graduated at Faculty of Pharmacy, Belgrade.Nostrified degree at La Sapienza Rome University, Italy. Master of Science at Pharmaceutical Medicine of Hibernia College, Dublin, Ireland and School of Government, Harvard University, Cambridge MA, SAD. Postgraduate cosmetology studies at Society of Cosmetic Scientists, Luton, UK. Specialty studies Public Relations at Faculty of Economics, Belgrade. Specialty studies at ICATS, Plymouth University, UK. Currently on specialty studies of Medicinal law at Faculty of Law, “Union” University, Belgrade. Certified expert for Translational medicine (Certified Professional for Translational Medicine CPTM with European Society for Translational Medicine, Vienna, Austria) since 2015.Certified Senior Project Manager (International Project Management Association IPMA).Certified lecturer at CRA Academy Belgrade, Serbia, since 2011.Former head of ACRP Serbian Chapter (2008-2011).Currently deputy of professional organization KLINIS.
Sinisa Radulovic was born in 1953 in Kovin. He graduated at the Medical Faculty, Belgrade, followed by specialty studies in clinical pharmacology. His master study area was pharmacology and doctoral thesis was based on oncology drug development. Member of many international scientific organizations, such as AACR, EACR, ASCO, ESMO, as well as a few Serbia-based societies. Currently working on development of new oncology drugs and early phase clinical trials. Manages a few oncology research projects. Published more than 150 papers internationally, more than 50 locally and about 10 monographs and chapters. Works as a director of Sector for Science and Education, Institute for Oncology and Radiology, Serbia.