Key Learning Outcomes
- Assess global and regional biosimilars pipeline and growth markets
- Understand what biosimilars sponsors are looking for
- Guidelines, approvals and current regulatory challenges in ASEAN
- Strategic consideration for success in the biosimilars market in Asia
- Product portfolio and product life cycle analyses
- Clinical & non-clinical study considerations
- Biosimilar manufacturing considerations
- Regulatory approach, pricing and market access case studies
- Biosimilar project risk management strategies
Who Should Attend
This course is of practical importance for those involved in product portfolio development, clinical and non-clinical strategies, regulatory affairs, bioanalytics & biomanufacturing, drug safety, risk management & commercialisation
- Commercial Leaders
- Regulations & Compliance, RA, QA, QC
- Clinical Strategy, Senior Research Scientists & Clinical Project Managers
- Product Portfolio
- Drugs Approval
- Medical Manager
- Patient safety and Patient affairs
- Supply chain
- Technical Services
- Therapeutic product developer
- Regulatory agency
Director, Challand Biosimilar Consulting Ltd
Rodeina has over 30 years’ experience across pharmaceutical, CRO sectors. She is experienced in overall biosimilar development and project management, from study design, regulatory considerations, CMC, to product launch and post-marketing evaluation.
Her expertise includes:
- Developed over 15 molecules including filgrastims, heparins,ninsulins, LMWH, growth hormones, monoclonal antibodies,nbiosimilar orphan drugs, Hospira’s GCSF & Retacrit
- Range of therapeutic expertise: oncology, nephrology,nanaemia, radiationnchemistry, hematology, rheumatology,ninfectious disease, immunology, cystic fibrosis, femalenhealth, contraception & HRT, orphan drug, dermatology, andnoptahlmology
- Conducts meetings with global regulatory agencies (EMA,nFDA, MENA, GCC, Australia, Singapore, India, Japan, South Korea) on biosimilars licensing requirements, clinical trial regulations and investigator education.
- Portfolio gap analyses, due diligence & feasibility studies
- Overall project management plan: Risk management, Global clinical trial projects, CRO selection, Budget Management ($300+ million)
- Setting and managing Scientific Advisory Boards with internal personnel and external KOLs
- Director of Clinical Projects and Head of Clinical Operations in the EU (Hospira Inc).
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
Upon completion of this training course, participants will earn a digital badge.
Earners of Biosimilars Certificate have acquired practical understanding of the commercial, regulatory environment in the Biosimilars market essential for analysing global and regional outlooks. They have practical knowledge in the Biosimimlar investment market, regulatory development with in-depth focus in Asia (e.g. GMP, regulatory audit, pharmacovigilance, naming & labelling); pricing & market access strategies; as well as non-clinical and clinical criteria in biosimilar drugs development.
Biosimilars, drug development, GMP, regulatory affairs, pharma pricing, market access, clinical studies, non-clinical studies, pharmacovigilance, manufacturing considerations, ROI, investment outlooks, portfolio management.
Attend and participate in the 2 full days of training course duration, led by the designated training expert
- GLOBAL & REGIONAL BIOSIMILAR
- Introduction: biologics, biosimilars and others
- Value of biologics and biosimilars
- Biosimilars – Global markets’ uptake to date:
- Drivers for rapid uptake
- Impacts on Health Care seen so far – global perspectives
- BIOSIMILAR PIPELINE
- Patent expiration- what next?
- Company profiles
- Financing for biosimilars – key considerations
- Investment and drug development partnerships
- GLOBAL REGULATORY OUTLOOK
- Global regulations and guidelines
- EU, US, LA, MENA, GCC, ROW
- ASEAN Markets Deep Dive – Guidelines, Approvals and Other Regulatory Matters
- Time frames, registration pathways, procedures and challenges
- Dossier requirements
- Similarities and differences with other reference agencies
- SCIENTIFIC ADVICE – CLINICAL TRIALS & DRUG DEVELOPMENTS
- The process: EU, US, Local EU countries, ASEAN, LA, MENA, GCC
- The timings & the importance
- The cost
- Clinical pharmacology (Comparative PK/PD Studies)
- How to maximise the benefit for you?
- CMC REGULATORY REQUIREMENTS AND STRATEGIES
- Choice of Reference product
- Target product profile
- Critical quality attribute
- Non-clinical comparability
- Supply chain considerations
- Risk minimisation strategies
- GMP compliance
- Labs & Manufacturing facilities
- DRUG CLINICAL & NON-CLINICAL TRIALS – KEY CONSIDERATIONS
- Animal Studies
- Safety & efficacy assessment
- SWITCHING, SUBSTITUTION & INTERCHANGEABILITY
- Current regulatory landscape
- Country-specific discussions
- Switch studies
- Real World evidence data
- Case Studies
- Safety evaluation
- Immunogenicity assays, safety & immunogenicity data
- Post-approval safety and PV systems
- Risk management plan
- Pharmacovigilance plan
- Post-marketing studies
- Real-world evidence data
- CASE STUDIES – PRICING & MARKET ACCESS STRATEGIES
- Market Access – regulators’ & payers’ considerations in ASEAN
- Case study with data from real-world dossier will be provided to participants
- BUDGET AND COST CONTROL – CASE STUDIES & EXERCISE
- Clinical & non-clinical studies
- Marketing and Market access
- NAMING & LABELLING STRATEGIES
- Propriety names
- FDA guidance on labelling and prescribing information
- Labelling rules
- Biosimilarity statement
- Administration, preparation, storage and safety information
- KEY SUCCESS FACTORS FOR BIOSIMILAR MARKET UPTAKE
- Success in the EU- why?
- Failure in the US- why?
- ROW- catching up but slowly- why?
- STRATEGIC CONSIDERATION FOR SUCCESSFUL UPTAKE IN ASIA
- Product knowledge and use- know your market
- Disease prevalence and current standard of care
- Education: biologics and biosimilars
- Legal issues and risk mitigation
- Patent & licensing risks
- Regulatory approval
- Lessons learnt from others
On-site & in-house training
Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?
Talk to us about an on-site/in-house & customised solution.