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25-06-2020 (Live Online)

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Live Online: Generic Drugs

Regulatory, Market Access & Product Development Strategies

25 – 26 June 2020 | Live Online

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REGISTER 2 DELEGATES & THE 3RD COMES FREE!
Early Bird Rate:  Register and Pay on or before 30 April 2020

overview

Key Learning Outcomes

  • Gain global updates on healthcare trends, therapeutic areas, generic drug demand and development pipelines, patents and trademarks
  • Health policies & reimbursement methodologies: US, Europe, Asia and ASEAN
  • Dissect ASEAN generic drug registration requirements
  • Examine course rulings and case law updates on generic market
  • Understand ASEAN regulatory affairs for generic products
  • Best practices for successful generic product’s market access in ASEAN
  • Develop a product strategy, business plan and lifecycle management

Who Should Attend

This course offers global and regional strategic thought leadership for those involved in product portfolio development, clinical and non-clinical strategies, market access, commercial, regulatory affairs, biomanufacturing, compliance:

  • Marketing Management, Product Commercial Management, Sales
  • Reimbursement, Market Access, Health Technology Assessment
  • Clinical Strategy, Research Scientists & Clinical Project Management
  • Product Portfolio
  • Licensing & Intellectual Property
  • Regulatory Affairs, Compliance, QA
  • Brand Management
  • Business Analysts
  • Insurance companies
  • Health providers and pharmacies

pricing

Packages Price
Live Online LearningSGD $2876SGD $2716Early BirdEarly Bird


Early Bird Rate:  Register and Pay on or before 30 April 2020

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate of 2-day main conference package only.
For Group Registrations, email register@informa.com or call +65 6508 2401

 

  • Special Group Discount pricing is applicable to groups of 2 or more delegates from the same organisation registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies – either the early bird rate OR the Special Group Discount.
  • All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.
  • View payment terms and bank transfer details, click here »

Trainer

DI Dr. Salma Michor A Practical Guide to Pharmacovigilance & Contract Manufacturing AgreementsDr. 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

Digital Badge

Upon completion of this training course, participants will earn a digital badge.

Eligibility:
Attend and participate in the 2 full days of training course duration, led by the designated training expert

Available to:
Seminar attendees

Digital Badge FAQ >

Live Online Learning

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.

  • Progress through the course with fellow participants as you would in a classroom
  • Conduct Q&A with course directors in real time
  • Effectively achieve learning objectives with minimal disruption to your busy schedules
  • Maximise cost saving with reduced travel and discounts for online participation
  • Earn your Digital Certification and broadcast your achievements to your peers
  • Deploy new age interactive tools to learn more from fellow participants

Click here to know more >

Agenda

HEALTHCARE TRENDS AND THE GENERICS MARKET

  • Key therapeutic areas and generic drug demand
  • Expiring patents and development pipelines
  • Import and Trade Market
  • Drug development opportunities
  • Trends in generic drugs’ approval across key therapeutic areas

UNDERSTANDING THE GENERICS VS BRANDED SUPPLY CHAIN MODEL

  • Product and money flow
  • Health plan rebates
  • Reimbursement methodologies

COMPARATIVE OVERVIEW ON REGULATORY REQUIREMENTS OF GENERIC PRODUCTS

  • Developments in the US (FDA)
  • Developments in Europe (EMA)
  • Developments in ASEAN Japan, China

CASE STUDY: DISCUSS RECENT COURT RULINGS AND CASE LAW UPDATES FOR GENERIC DRUG MARKET

  • Competition and antitrust law
  • Intellectual Property and trademark

COMPETITION OF GENERIC DRUG REGISTRATION REQUIREMENTS IN ASEAN COUNTRIES

  • ACTD
  • Technical documentation
  • Quality documents
  • Non-clinical
  • Clinical
  • Comparison with EU/US

FOCUS ON ASEAN REGION REGULATORY REQUIREMENTS

  • The Pharmaceutical Inspection Co-operation Scheme
  • Certificate of Pharmaceutical Product (CPPs)
  • ACTD/CTD Acceptability
  • Pharmacopoeias acceptability
  • Minor variation & major variation products
  • Harmonisation of technical guidelines
  • Halal compliance for Muslim patient population
  • Stability

OVERVIEW OF PATENTS AND TRADEMARKS FOR GLOBAL GENERICS: EU/US AND ASEAN

  • Adoption of EU Bolar legislation
  • Exceptions to normal patent law
  • Applications to generics
  • Applications to biosimilars

KEY REQUIREMENTS FOR GLOBAL GENERIC AUTHORISATION

  • Overview of CTD requirements for global generics
  • BE / BA requirements
  • Electronic submission and the CDT

CASE STUDY – MARKET ACCESS FOR BRANDED GENERIC PRODUCTS

  • Reimbursement landscape
  • Prescriptions
  • Dispensing
  • Purchasing traditions
  • Advertising & Promotional authorisation
  • Marketing authorisation
  • Safety labelling requirements for generic drugs

POTENTIAL REGULATORY CHALLENGES FACING BIOSIMILARS / FOLLOW-ON BIOLOGICS MARKET

  • Examining the proposed EU regulatory guidance for the emerging biogenerics market, clarifying bioequivalence and biosimilar data requirements.
  • Comparison with the US approach
  • Comparison with China
  • ASEAN

Case Studies – Regulatory Requirements, Market Access & Pricing LMIC Countries
Exercise: Developing a Business Plan for New Generic Product Launch

POSTMARKETING SURVEILLANCE OF GENERIC DRUGS

  • Post-marketing pharmacovigilance
  • Adverse event reporting
  • Product recall case studies

DISCUSSION – LIFECYCLE MANAGEMENT FOR BRANDED PRODUCTS

when & where

25 - 26 Jun 2020

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.

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