Day
One
Wednesday
22rd September
| DAY
ONE| DAY TWO|
STRATEGIC SOURCING OF
APIS|
|
Chair:
Ian Senior
Special Advisor
National Economic
Research Associates (NERA), UK |
|
|
| 09.00 |
Registration and coffee |
| 09.30 |
Opening remarks from the Chair |
| 09.40 |
The international healthcare market and the role of
generic drugs
Examining developments in the generics market over
the last ten years
A macro view of pharmaceutical revenues over the next
ten years
Opportunities/imperatives for the generics pharmaceutical
industry
Graham Lewis
Managing Director
IMS Strategic Global Solutions, UK
|
MARKET
REVIEWS
Developing markets for generic products: Assessing
the opportunities offered by low price countries
|
|
|
| 10.20 |
Spain
Conditions imposed on EFGs
The patent system
Generic substitution
Reference product requirements
Reference pricing
Jordi Faus
Faus & Molliner, Spain
|
| 11.00 |
Morning coffee |
| 11.30 |
Italy
Overview of Italian healthcare system
Pricing systems in Italy
Opportunities in the generic medicines market
Strategies for success in the Italian generic market
The future of the market Dr Hilke Baasch Pharmaceutical
Development Manager
Bracco, Italy
|
| 12.10 |
France
Overview of French healthcare system and potential
changes
Assessing the potential of the generics market, identifying
market drivers
Strategies for growth
Evaluating the future direction of the French generic
market
Jean Michel Peny
Vice President
ISO Health Care Group, France
|
| 12.50 |
Lunch |
| Emerging
markets for generic products: Opportunities
for growth |
|
|
| 14.00 |
South Africa Market segmentation and specific
opportunities for generics in the South African market
Demographics
Patent issues
Registration issues
price evolution generic versus originator
value and volume relationships in different segments
Ignatius M Viljoen
Former CEO
Rolab, part of Novartis, South Africa
|
| 14.40 |
India
Evolution of the Indian market
Status of intellectual property laws
Strategy of leading Indian companies
What next for the Indian market?
Brian Tempest
Regional Director, Europe, CIS and Africa
Ranbaxy, UK
|
| 15.20 |
Afternoon tea |
| Established
markets for generic products |
|
|
| 15.50 |
USA Clarifying recent changes to generic registration
in the USA
Individual versus average bioequivalence
Update on FDA initiatives with regard to implication
of ICH
Site specific stability and the Draft Stability Guidance
Draft impurities guidance
SUPAC/BACPAC update
Blend uniformity
Guidance for non absorbed drug dosage forms
Electronic ANDA submissions
Deborah Miran
Miran Consulting Inc, USA
|
| 16.30 |
USA 180 day generic market exclusivity
Current status and strategic implications
Andrew Berdon
Vice President and General Counsel
Purepac Pharmaceutical Company, USA |
| 17.10 |
Canada
Overview of the Canadian generics market - the players,
the market, the payers, the trends
Legal position of the market
Future trends and opportunities
Judy Gold
Director, Purchasing
Novopharm, Canada
|
| 17.50 |
Closing remarks from the Chair |
| 18.00 |
You are invited to join us for a drinks reception where
you will have the opportunity to talk with speakers, fellow
delegates and exhibitors |
| 18.30 |
Close of day one |
|
Day
Two
Thursday
23rd September
| DAY
ONE| DAY TWO|
STRATEGIC SOURCING OF
APIS| |
Chair:
Ian Senior
Special Advisor
National Economic
Research Associates (NERA), UK |
|
|
| 09.00 |
Morning coffee |
| 09.10 |
Opening remarks from the Chair |
|
|
| 09.20 |
Assessing the advantages and disadvantages of entering
into the generics market
Factors involved in the decision making process
Product portfolio: where does the potential for generics
lie?
Requirements and needs of a successful generics business
Identifying the business benefits of opting out
Norbert Bangert
Manager Generics
Bayer AG, Germany
|
| 10.00 |
The legal framework for generic drugs
Single trademark requirement
Packaging and labelling guidelines
Roche Bolar exemption the status in Europe
Stephen Kon
S J Berwin, UK
|
| 10.40 |
Morning coffee |
| 11.10 |
Pricing and reimbursement policies and their influence
on the generics market
Drivers for in-patent, generic and non-prescription
medicines
Role of government, health funds, doctors and patients
Will a 'fourth hurdle' for new research-based medicines
benefit generics?
How could the impact of a Bolar exemption be measured?
Ian Senior
Special Advisor
National Economic Research Associates, NERA, UK
|
|
|
Chair:
Tony Cartright
Senior Director, Regulatory Affairs
Parexel International Ltd, UK |
| 11.50
|
Developing
a strategy to facilitate successful mutual recognition
applications despite the lack of harmonisation
Assessing the future use of the mutual recognition
procedure for generic applications
Opportunities made available by the ECJ ruling
Constraints and opportunities set by the Commission
communication
John McGuire
Parexel International Ltd, UK
|
| 12.30 |
ICH and its impact on the generic pharmaceutical industry
Current status of ICH initiative
Future ICH developments
ICH specifications guidance
The Common Technical Document
Implications for the generic pharmaceutical industry
David Parsons
Head of Group Regulatory Affairs
Stafford Miller Ltd, UK
|
| 13.10 |
Lunch |
| 14.30 |
Speeding up the registration process through effective
bioequivalence studies
Selecting the most appropriate comparator product
Varying European requirements
Bioequivalence for modified/slow release products
Christopher Kirkpatrick
Associate Director, Phase I Research
Chiltern International, UK
|
| 15.10 |
Assessing the progress towards a globally recognised
comparator product
Current national comparator products
Deciding on the selection criteria used in assessment
Working towards an international list of comparator
products
How close are we?
Juhan Idanpaan Heikkila
Special Advisor for Quality Assurance and Safety
of Pharmaceuticals, Health Technology and Drugs
World Health Organisation, Switzerland
|
| 15.50 |
Closing remarks from the chair |
| 16.00 |
Afternoon tea |
| 16.30 |
Close of conference |
|
24th
September 1999 Brussels, Belgium
Strategic
Sourcing of Active Pharmaceutical Ingredients For Competitive
Advantage
| DAY
ONE| DAY TWO|
STRATEGIC SOURCING OF
APIS| |
Chair:
Jean Hoffman
President
Newport Strategies
Inc, USA |
|
|
| 09.00
|
Registration
and coffee |
| 09.20 |
Opening remarks from the Chair |
| 09.30 |
Understanding the driving forces shaping the API industry
and assessing future scenarios for the sourcing of APIs
Assessing the impact of changing pressures from the
brand and generics companies on the API market
What implications does the growth of the Asian API
markets have on the industry?
Implications of increased competition
Increased regulation of APIs
Identifying and capitalising on opportunities in the
changing API market
What does the future hold for the international API
market?
Enrico Polastro
Arthur D Little, Belgium
|
| 10.10 |
Competitive advantage through strategic sourcing of APIs
Which comes first, sourcing or marketing decisions
How product marketing and development choices interconnect
with sourcing
Targeting profitable products through competitive
analysis of APIs
Impact of API availability on generic pricing: Lessons
from Mylan
Future scenarios: Wil
bloodbaths or niche products predominate?
Impact of brand trends on API availability
Jean Hoffman
President
Newport Strategies Inc, USA
|
| 10.50 |
Morning coffee |
| 11.20 |
Auditing potential API suppliers: getting the facts for
the best choice
Identifying potential future suppliers
Thinking strategically to ensure you make the right
choice
Avoiding common pitfalls in the selection of a supplier
Obtaining reliable information, ensuring the right
questions are asked
Managing price over the life cycle of a product
what is a good price?
Tom Buggy
Vice President Quality Operations
Hovione SA, Portugal
|
| 12.00 |
A generic companies perspective on effective sourcing
of APIs
Examining the drivers behind generic companies sourcing
decisions
Identifying potentia
sources
Single versus multiple sourcing
Finding and selecting suitable suppliers
Ongoing audits to ensure standards are maintained
Minimising supply risks
Planning ahead for future demands of the generics
industry
Speaker to be confirmed
|
| 12.40 |
Lunch |
| 14.00 |
Examining the current status of intellectual property
(IP) protection and patent legislation and its implications
for sourcing APIs
Clarifying the current patent laws, the differences
and their implications for APIs and generics in the
US and Europe product, process and formulation
patents
GATT/TRIPS and their impact currently on IP protection
in Asia
Clarifying the use of Supplementary Protection Certificates
and their impact for the sourcing of APIs
Update on the Bolar Amendment and progress in Europe
Ensuring your supplier isn't infringing patents
Morag Macdonald
Bird & Bird, UK
|
| 14.40 |
Maximising the potential of China as a source of APIs
Overview of the Chinese pharmaceutical industry
Trends in the Chinese pharma market
Quality and regulatory compliance
Exploring the potential for alliances and co-operative
agreements
Critical success factors for sourcing from India
Susan Capie
General Manager
PDM Pharmatec Ltd, USA
|
| 15.20 |
Proposed guideline for GMP of APIs and EC Draft Directive
on GMP for starting materials and inspections
Assessing the current proposals for ICH Q7: manufacturing,
processing, packaging and storage of APIs
Examining currently unresolved issues
Estimated timeframe for the completion and implementation
of ICH Q7
Forerunners of the draft directive on GMP for starting
materials and inspections
Implications of the current scope
Timetable for the implementation of the directive
Norman Franklin
Interactive, UK
|
| 16.00 |
Closing remarks from the Chair |
| 16.10 |
Close of conference Afternoon tea will be served |
