Key Learning Outcomes
- Legal aspects underpinning clinical trials (globally and Asian region): Data Privacy and Integrity, Ethical Principles, Financial Transparency and Authorisations
- Important and amended regulations in clinical trials and how they affect study designs & protocol
- Risk-based quality management in clinical trials especially for Asia
- Key considerations in use of technology in clinical trials
- Develop effective study designs for multi-country clinical programmes
- Regulatory risk assessment and mitigation
- Best practices in inspection preparation
- Case studies of protocol deviation, violations and prevention
Who Should Attend
Executives involved in Clinical Trials, Risk Management, Regulatory Affairs & Quality Control from Pharmaceutical Manufacturing, CRO, Consulting companies:
- Medical Affairs
- CRO Management
- Site Management
- Regulatory Affairs
- Budgeting & Outsourcing
- Project Management
- Quality Assurance, Quality Control
- Patient Affairs/Patient Recruitment
- Data Management, Data Operations, Clinical Statistics Management
- Contract, Finance, Purchasing, Project Controller
- Clinical Trials (Oversights, Development, Outsourcing, Monitoring)
Dr. Salma Michor (PhD, MSc, MBA, CMgr, RAC-Treasurer), CEO, Michor Consulting
Salma has advised numerous global clients across Pharmaceutical, Medical and Food industries, including J&J, Novartis, Pfizer and Shire and many more.
She had previously worked for Torrex-Chiesi (Chiesi Farmaceutici S.p.A); Wyeth Whitehall Export, and Croma Pharma GmbH and had been the Director of Global Supporting Operations – Medical Devices and Pharmaceuticals (Ophthalmology & Orthopedics) where she was in-charge of technical and leadership of four departments – including Regulatory Affairs and Compliance; Medical and Vigilance; Change Control and Life Cycle Management; as well as Packaging and Pharmaceutical editing. Her duties included overall leadership & personnel management, budgeting and strategic planning, liaison with external contractors, doctors and customers in 60 countries worldwide. Here she also gained first-hand experience with submission of clinical trials phases: I-III as well as turnaround management of post-Mergers and Acquisitions integration operations.
Her experiences include:
- Post-acquisition phase-out and closedown after M&As
- Managing DCP registrations
- Consolidation of Multi-language labelling texts for pharmaceutical products and medical devices
- Forming clinical and registration strategies for medicinalproducts (combination, generics)
- Labelling compliance for drugs & food supplement
- Authoring CMC sections for drug products or drug/devicecombination products
- Preparing pharmaceutical and medical device companiesfor internal and FDA audits
- Managing large company-wide compliance projects (CAPA, GMP, ISO, etc)
- Preparing companies in 3rd countries for EMA, MHRA and AGES inspections and managing the whole biotech registration and clinical testing in the EU
Upon completion of this training course, participants will earn a digital badge.
Attend and participate in the 2 full days of training course duration, led by the designated training expert
Live Online Learning
Stay Home. Skill Up!
The current Covid-19 pandemic has put strains on various areas of business, especially when it comes to deriving commercial value from new initiatives. During this phase of self-isolation and working from home, we can help you meet your professional development needs and you can still take your professional development plans to the next level.
To support your learning goals we have converted our face-to-face trainings to LIVE Online Sessions. This way you can continue to attend live and interactive training sessions within the virtual classroom space where you can see and speak, with your Subject Matter Expert and other participants.
Benefits of Live Online Learning
Aimed at offering you immediate, high-quality practical information whilst minimising time and expenditure associated with travelling, our digital training platform enables you to interact in real time with course directors and remotely network with your fellow participants.
- Classroom Experience: Progress with fellow participants as you would in an on-site class
- Guaranteed cost-effectiveness: Travel budget saving, plus 20% price advantage for online participation
- Controlled environment with speakers managing the Q&A and discussions and tools for enhanced interactions
- Module-based approach to effectively manage your time and revisions
- Earn your Digital Certification and broadcast your achievements to your peers
- Onboarding: Available for all attendees
- Proven and secure training platform
LEGAL ASPECTS UNDERPINNING CLINICAL TRIALS
- Regulatory obligations of a Private Investigators (PI) – guidelines from GCP, IRB
- PDPA, GDPR and equivalents globally
- Health products (Clinical Trials) Act and
- Medicines (Clinical Trials) Act
- Informed consent/consent requirements.
- Specific issues:
- Consent requirement for minors
- adults lacking capacity
- Subject projection
- Investigational medicinal product (GMP Directive)
OVERVIEW OF THE FRAMEWORK OF CLINICAL TRIAL REGULATIONS
Global, Europe & US
- Understanding the history of clinical trial regulations
- EuradrLex 10 contents explained – Pharmaceutical Clinical Trial legislation
- ICH and its importance
- ICH GCP principles to apply to all clinical trials
- Problems experienced complying with regulations and guidelines for running clinical trials – group discussion to share experiences
- Key FDA requirements which differ from
- EU requirements – what are the key differences?
- Understanding the clinical trial regulations
- Overview of the current requirements
- What have the main problems and challenges? Examples of real scenarios
- Overview of the major new requirements of the Clinical Trial Regulations
- Specific focus in
- China, Hongkong and Taiwan
- Singapore, Thailand and Vietnam
- Indonesia, Malaysia, Philippines
GOING GLOBAL: SIMULTANEOUS DEVELOPMENT IN CHINA, US, AUSTRALIA, EU
- Should You File IND in the US Before/After or Simultaneously Alongside Your China IND?
- What Are the Opportunities and Benefits of Conducting Trials in Australia
- Identify the Best Trial Management Strategies for Running your Clinical Development Programs in the US + China
- Learn from Case Studies from Biotechs Who Have Successfully Received IND Approval from US FDA
Case Study – Develop a global strategy for a new oncology drug trial
ETHICS COMMITTEE (EC) SUBMISSIONS AND APPROVAL
- The role of the sponsor and investigators in completing the Ethics Committee applications (group discussion to share experiences of how to efficiently obtain EC approvals)
- Subject advertising
- Informed consent requirement
- Ethical issues with clinical trials and protocol design
- Ethical considerations for running trials including in countries outside of traditional countries
CLINICAL TRIAL REGULATORY AUTHORISATION AND AMENDMENTS
- The CTA (Clinical Trial Authorisation) application for submission to the regulatory authority
- The CTA and amendments
- Clinical Trial Notification
- Clinical Research Materials
- Substantial amendments/“substantial modifications” and non-substantial amendments – discussion of the differences
- Ongoing and end of study reports
- Regulatory requirements for clinical trials
- Example: US IND & IND
Group Exercise: Ensuring Data Integrity In Your Clinical Trials
OVERVIEW OF RECENT DEVELOPMENT IN CLINICAL TRIAL REGULATIONS
- EU inspection guidelines e.g. inspection of sponsors and CROs
- EMA guideline on requirements for firstin- man clinical trials of potential high-risk medicinal products
- EMA reflection papers including: riskbased quality management of clinical, on data from third countries, electronic Trial Master Files
- Transparency in clinical trials – clinical study reports being available
- FDA guidance risk-based monitoring
- Guidance for Industry– Electronic Source Documentation in Clinical Investigations
- Guidance for IRB continuous review of studies
- Event Reporting- Improving Human Subject Protection
- Financial Transparency in Clinical Trials
- FDA guidance on Financial Disclosure
- Global compliance obligations in transactional reporting
- Centralisation of data and financial activities related to clinical trials
- Post marketing studies and Clinical trials – risk identification & analyses system
Case Study – What risk-based aspects of global clinical trials are relevant for Asia
ACCELERATING CLINICAL TRIALS IN ASIA
- How can clinical trial timelines be accelerated in Asia?
- Where are the opportunities for clinical trials in Asia?
- How do you ensure readiness for FDA inspections in Asia?
- How do you ensure efficient and costeffective trial operations in Asia?
- What is the key to successful global clinical trial conduct in Asia?
- How do you integrate risk-based monitoring for trials in Asia?
Exercise: Regulatory Affairs in Conducting Multi-national Trials
PHARMACOVIGILANCE AND ADVERSE EVENT REPORTING
- Adverse event reporting – requirements and definitions
- Safety reporting requirements
- What are the reporting requirements for SUSARs, DSURS, adverse events and adverse reactions?
CLINICAL TRIAL REGULATORY RISK ASSESSMENT AND MITIGATION
- Structured approach to noncompliance risk assessment and mitigation
- GCP Corrective action and preventive plans in conducting and reporting clinical trials
- Identification and definition of risk factors: CT protocol/study design, asset, operational factors
- How to prepare for inspection
- The latest inspection policies and findings
- What questions do inspectors ask? And tips on how to answer these
COMPLIANCE CONSIDERATIONS REGARDING TECHNOLOGY USE IN CLINICAL TRIALS
- Mobile technologies in data collection, storage, analyses, access and transfer in CT
- Real time data sharing with study participants – decision support tool
- Privacy implications
when & where
30 Jun - 03 Jul 2020
23 – 26 June 2020
Generic Drugs »
29 June – 2 July 2020
Pharma Regulatory Affairs Risk Management »
7 – 10 July 2020
Pharma Pricing »
14 – 17 July 2020
Biosimilars – Regulation, Drug Development & Commercialisation »
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