| 2010
19 July Syndey, Australia
|
| AusBiotech Bioprocourse |
| Advancing from Concept to Clinic and Beyond |
Dr. Dianne Jackson-Matthews (speaker) |
|
| 2010
21 - 23 June Barcelona, Spain
|
| Phacilitate Vaccines/Immunotherapies |
| Workshop: EMEA regulatory update: Clarifying recent and novel guidelines, and delivering the keys to successful and efficient navigation (June 23rd: 1.40-2pm) |
Dr. David Kirke (speaker) |
|
| 2010
14 - 18 June Manchester, UK
|
| Recombinant Antibodies Informa 2010 |
| Workshop: Biosimilar Antibodies – A Global Regulatory Perspective (17th June) |
Dr. Chris Holloway and Dr. Gavin Edwards (speaker) |
|
| 2010
27 - 28 May Sydney, Australia
|
| ARCS 2010 Congress |
| Diligence in Early-phase Biotech Development: Preclinical, Regulatory and Clinical Strategies |
Dr. Dianne Jackson-Matthews (speaker) |
|
| 2010
4 - 6 May Philadelphia, USA
|
| Biomarker World Congress |
| |
| Dr. Patricia Hurley (Head of Project Management) will be available for meetings at our exhibition stand.
|
|
| 2010
21 April Adelaine, Australia
|
| Ausbiotech Bioprocourse |
| Advancing from Concept to Clinic and Beyond |
Dr. Dianne Jackson-Matthews (speaker) |
| |
| For more information on this event and how to register please
click here |
|
| 2010
20 April Melbourne, Australia
|
| Ausbiotech Bioprocourse |
| Advancing from Concept to Clinic and Beyond |
Dr. Dianne Jackson-Matthews (speaker) |
| |
| For more information on this event and how to register please
click here |
|
| 2010
12 - 14 April Korea
|
| IBC’s Biomanufacturing and single-use Systems Summit |
| Comparability: Developing Strategies for Scaling up and other process changes |
Dr. Dianne Jackson-Matthews (speaker) |
|
| 2010
25 March New Zealand
|
| ARCS Training Course |
| Regulation of Pharmaceuticals in the USA |
Dr. Dianne Jackson-Matthews (speaker) |
|
| 2010
23 - 24 March London, UK
|
| Biomakers Triconference |
| Integrating your Biomarker into Drug Development: The Importance of the EMEA/FDA Qualification Procedures |
Dr. Patricia Hurley (speaker) |
|
| 2010
22 - 24 March Auckland, New Zealand
|
| NZ Bio 2010 |
|
| Dr. Dianne Jackson-Matthews (Deputy Group Director of Regulatory Affairs) will be available for partnering meetings. |
|
| 2010
8 - 10 March Barcelona, Spain
|
| BioEurope Spring 2010 |
|
| Dr. Chris Holloway (Group Director
of Regulatory Affairs) and Mr. Paul Cronin (Business Development Manager) will be available for partnering meetings. |
|
| 2010
25 - 26 February Manchester, UK
|
| 5th Annual Biomarkers Congress |
| Opportunities in the regulatory framework to support biomarker development: Comparing and contrasting Europe and the USA |
Dr Patricia Hurley (chair of panel discussion) |
| |
| Dr. Chris Holloway (Group Director
of Regulatory Affairs) will be available for partnering meetings. |
|
| 2010
23 - 25 February New York, USA
|
| 9th Annual Bio Windhover 2010 |
|
| Mr. Paul Cronin (Business Development Manager) will be available for partnering meetings. |
|
| 2010
23 - 24 February London, UK
|
| Informa Life Sciences: 11th Annual Phase I Clinical Trials |
| Advanced Therapy Phase I trials |
Dr Robert Blakie (speaker) |
|
| 2010
23 February Sydney, Australia
|
| ARCS Training Course |
| Regulation of Pharmaceuticals in the USA |
Dr Dianne Jackson-Matthews (speaker) |
|
| 2010
4 - 5 February Korea
|
| KoNECT and Asian Medical Center Symposium |
| Regulatory updates in the USA |
Dr Dianne Jackson-Matthews (speaker) |
|
| 2010
1 - 2 February Geneva, Switzerland
|
| Biosquare 2010 |
| |
| Mr. Paul Cronin (Business Development Manager) will be available for partnering meetings. |
|
| 2010
24 - 26 January Washington DC, USA
|
| Phacilitate: Cell & Gene Therapy Forum 2010 |
| Workshop: ‘Regulatory Surgeries’ |
| Dr. Chris Holloway (speaker) |
| |
| Dr. Patricia Hurley (Head of Project Management) will be available at our exhibition booth |
|
| 2010
24 - 26 January Vancouver, Canada
|
| Biopartnering North America |
Mr. Paul Cronin (Business Development Manager) will be available for partnering meetings. |
|
| 2010
21 January
|
| Audio conference through FX Conferences |
| Topic: Opportunities in the regulatory framework to support biomarker development: Comparing and contrasting Europe and the USA |
| Dr.
Patricia Hurley (speaker) |
|
| 2009
10 - 11 December
London,
UK |
| Genesis 2009 |
| Comparing the FDA and EMEA approaches to approval for biomarkers |
| Dr. Patricia Hurley
(speaker) |
| |
| Mr. Paul Cronin (Business Development
Manager) and Dr. Kirsten Messmer (Assistant Manager Business Development and Client Services) will be available for meetings at our exhibition stand. |
|
| 2009
7 - 8 December
London,
UK |
| Visiongain Vaccine Research & Development |
| Current regulatory concerns regarding long-term safety of vaccines |
| Dr.
David Kirke (speaker) |
|
| 2009
16 - 18 November
Brussels,
Belgium |
| Informa Vaccines Europe |
| Workshop: A Practical Approach to Comparability Studies for Vaccines |
| Dr.
David Kirke (speaker) |
|
| 2009
9 - 11 November
Boston,
USA |
| Oncology Leaders Forum |
| Avoiding regulatory pitfalls associated with novel platforms in oncology |
| Dr. Chris Holloway (speaker) |
|
| 2009
5 - 6 November
Barcelona,
Spain |
| European Biomarkers
Summit |
| Biomarker Qualification: Europe is
ready, are you? |
| Dr. Patricia Hurley
(speaker) |
| |
| Mr. Paul Cronin (Business Development
Manager) and Dr. Patricia Hurley (Head of Project
Management) will be available for meetings at our
exhibition stand. |
|
| 2009
5 November
Beijing, China
|
| SFDA Biosimilars workshop |
| Importance of Molecular Similarity - Ensuring the quality and comparability of biosimilar products |
|
| 2009
2 - 4 November
Vienna, Austria |
| BIO-Europe 2009 |
| Mr.
Robert Blakie (Director of Regulatory Affairs)
and Mr. Paul Cronin (Business Development Manager)
will be available for partnering meetings. |
|
| 2009
27 - 30 October
Melbourne,
Australia |
| AusBiotech |
| Product
Development and Regulatory Aspects in Asia-Pacific
Region. |
| Dr. Chris Holloway (chairperson) |
| |
| Dr. Chris Holloway (Group Director
of Regulatory Affairs), Dr Dianne Jackson-Matthews
(Deputy Group Director of Regulatory Affairs) and
Mr. Tristan Elliott (Business and Operations, Australasia)
will be available for partnering meetings. |
|
| 2009
22 October
Brisbane,
Australia |
| QCTN: Stem Cell Symposium |
| Stem
cell products and regulations. |
| Dr. Chris Holloway (speaker) |
|
2009 22 October
Munich,
Germany |
| Medical BioDefense Conference |
Regulatory Approaches to Biodefence Products in Europe and USA - Compare and Contrast |
Mr Robert Blakie (speaker)
|
|
| 2009
11 - 14 October
London, UK |
| BioPartnering Europe
and BioPartnering China |
|
Mr Paul Cronin (Business Development Manager)
and Mr. Tristan Elliott (Business and Operations,
Australasia) will be available for partnering
meetings. |
|
2010
5 - 8 October
Lyon, France |
| World Vaccines Congress |
| Vaccine
Regulatory Framework Day |
| Dr.
David Kirke (speaker and chair) |
|
2009 30 September - 2 October
Brisbane,
Australia |
| Bioprocessing Network Conference 2009 |
Process Specifications in Biomanufacturing: Case Studies |
Dr. Dianne Jackson-Matthews (speaker)
|
|
| 2009
23 - 25 September
Lille, France |
| EuroBiO 2009 |
| Regulatory
Workshop: Opportunities and Challenges for Biosimilars
in the Global Market |
| Mr.
Robert Blakie (speaker and chair) |
|
| 2009
16 - 18 September
San Francisco,
USA |
| BioPharma America 2009 |
| Dr.
Chris Holloway (Group Director of Regulatory Affairs)
and Mr Paul Cronin (Business Development Manager)
will be available for partnering meetings. |
|
| 2009
16 - 18 September
Seoul, Korea |
| BIO Korea |
| Early
Phase Product Development: Helping Korean Companies
to Access Western Market |
| Dr.
Dianne Jackson-Matthews (speaker) |
|
2009
15 September
San Francisco,
USA
Educational
Division of the ERA Consulting Group |
| intERActions Seminar |
| Including Europe in your strategy to add value
to early stage biotech product development |
Dr.
Chris Holloway (speaker) |
| |
| For more information on this event
and how to register please click
here |
|
2009
14 September
San Francisco,
USA
Educational
Division of the ERA Consulting Group |
| intERActions Seminar |
| The regulation of 'Advanced Therapy Medicinal
Products' (cell therapy, gene therapy and tissue
engineered products) in Europe, from the clinic
to approval |
Dr.
Chris Holloway (speaker) |
| |
| For more information on this event
and how to register please click
here |
|
| 2009
17 - 20 August
Bogota, Columbia |
International
Seminar on Biotechnology:
Current
Status of Biopharmaceuticals in Columbia and the
World |
Bioequivalence
and the Immunogenicity of Biopharmaceuticals:
clinical consequences. |
| Case
studies of biopharmaceuticals comparability: changes
made to the original product; biosimilars.
|
| Clinical
evaluation of the efficacy and security of biologics
(Regulation*). |
| Dr. Chris Holloway (speaker) |
|
| 2009
29 June - 1 July
Barcelona,
Spain |
| Euro-Biotech Forum 2009 |
| Mr
Paul Cronin (Business Development Manager) and
Dr Patricia Hurley (Head of Project Management)
will be available for partnering meetings |
|
| 2009
25 June
London, UK |
| EPIC |
|
Mr Robert Blakie (Director of Regulatory Affairs
and General Manager, UK), Dr Patricia Hurley (Head
of Project Management) and Mr Paul Cronin (Business
Development Manager) will be available for partnering
meetings. We will also be available at our exhibition
booth |
|
| 2009
22 - 24 June
Barcelona,
Spain |
| Phacilitate Active Immunotherapeutics/Vaccine
Forum 2009 |
| Workshop:
Optimising the value of preclinical R&D to
increase the potential of success in the clinic.
Regulatory Perspective: What is the safety package
required to progress first-in-man trials with
an active immunotherapeutic, and what types of
data can support your animal model work? |
| Dr.
Deirdre McIntosh (speaker) |
| |
| Workshop:
Influenza vaccines: Is industry supplying what government
and public health demand? |
| Dr. David Kirke (moderator) |
| |
| Plenary
Session: Bringing novel adjuvants to market: Gaining
clarity on regulatory pathways and clinical data
requirements upon which to build the business model |
| Dr. David Kirke (panelist) |
|
| 2009
21 - 25 June
San Diego,
USA |
| DIA 2009 |
| Adding
value to early stage biotech product development |
| Dr.
Chris Holloway (chair) |
|
| 2009
15 - 19 June
Cologne, Germany |
| Informa Recombinant
Antibodies 2009 |
| European regulatory expectations applicable
to early development of recombinant antibodies:
The legacy of Tegenero (TGN 1412) 3 years on |
| Dr
Gavin Edwards (speaker) |
|
| 2009
18 June
London, UK |
| Regenerative Medicine:
A Forum For Clinical Need |
| Dr
Christopher Bravery (scientific panel and
speaker) |
|
| 2009
15 - 17 June
Tel Aviv,
Israel |
| ILSI-BIOMED ISRAEL 2009 |
| Mr
Robert Blakie (Director of Regulatory Affairs
and General Manager, UK) and Ms Caroline Tolley
(Assistant Manager, Business Development) will
be available for partnering meetings |
|
| 2009
14 - 16 June
San Diego,
USA |
| CALAsia |
| Workshop: Let's discuss innovation
in the Asia-Pacific region: It's happening everywhere.
Where are the hubs of activity? What are the assets?
Can you access these resources? |
| Dr.
Chris Holloway (speaker) |
|
| 2009
12 June
Sydney, Australia |
| AusBiotech Professional
Development Workshop 2009 |
| Advancing from concept to clinic and
beyond: Understand and engage US and European regulators
and achieve your approvals faster. |
| Dr.
Dianne Jackson-Matthews (speaker) |
| |
| For more information on this event
and how to register please click
here |
|
| 2009
10 June
Melbourne,
Australia |
| AusBiotech Professional
Development Workshop 2009 |
| Advancing from concept to clinic and
beyond: Understand and engage US and European regulators
and achieve your approvals faster. |
| Dr.
Dianne Jackson-Matthews (speaker) |
| |
| For more information on this event
and how to register please click
here |
|
| 2009
9 June
Brisbane,
Australia |
| AusBiotech Professional
Development Workshop 2009 |
| Advancing from concept to clinic and
beyond: Understand and engage US and European regulators
and achieve your approvals faster. |
| Dr.
Dianne Jackson-Matthews (speaker) |
| |
| For more information on this event
and how to register please click
here |
|
| 2009
18 - 21 May
Atlanta, USA |
| BIO2009 |
| Dr
Chris Holloway (Group Director of Regulatory Affairs)
and Mr Paul Cronin (Business Development Manager)
will be available for partnering meetings. We
will also be available at our exhibition booth
|
|
| 2009
3 - 6 May
San Diego,
USA |
| ISCT's 15th Annual Meeting |
|
Preparation and maintenance of quality and manufacturing
regulatory submissions (CMC) |
| Dr.
Christopher Bravery (panelist and speaker) |
|
| 2009
13 - 15 April
New York,
USA |
| BioWindhover 2009 |
|
Dr Chris Holloway (Group Director of Regulatory
Affairs) and Mr Paul Cronin (Business Development
Manager) will be available for partnering meetings |
|
| 2009
8 April
Rockville,
USA |
| Hopkins Biotech Network |
| Similar
Biological Medicinal Products and their regulation:
Europe versus the US |
| Dr.
Chris Holloway (speaker) |
|
| 2009
18 March
London, UK |
| London Biotech Network:
BioWednesday |
| Early
phase clinical trials: Opportunities for UK biotech
companies from the regulatory perspective |
| Dr.
Chris Holloway (speaker) |
|
| 2009
16 - 18 March
Milan, Italy |
| BioEurope Spring 2009 |
|
Dr Chris Holloway (Group Director of Regulatory
Affairs) and Ms Caroline Tolley (Assistant Manager
Business Development) will be available for partnering
meetings |
|
| 2009
9 - 11 March
Lyon, France |
| BioSquare 2009 and BioVision
Life Sciences Forum |
|
Mr Paul Cronin (Business Development Manager)
and Ms Caroline Tolley (Assistant Manager Business
Development) will be available for partnering
meetings |
|
| 2009
9 - 11 March
Auckland,
New Zealand |
| NZBio 2009 |
| Biotech
product in early development? Manage regulatory
risks! |
| Dr.
Dianne Jackson-Matthews (speaker) |
|
| 2009
2 - 6 March
Berlin, Germany |
| Informa Cell Line Development
and Engineering |
| Regulatory
considerations in cell line development |
| Dr.
Deirdre McIntosh (speaker) |
|
| 2009
8 - 10 February
Vancouver,
Canada |
| Biopartnering North
America |
| Dr
Chris Holloway (Group Director of Regulatory Affairs)
and Mr Paul Cronin (Business Development Manager)
will be available for partnering meetings |
|
| 2009
26 - 29 January
Washington
DC, USA |
| Phacilitate Vaccine/Cell
& Gene Therapy Forum 2009 |
| Deciding when to take the national
and when to take the centralized route in Europe:
Reaping the benefits of making the right strategic
choice |
| Dr.
David Kirke (speaker) |
| |
| The EU regulatory framework for Advanced
Therapy Medicinal Products: Practical case studies
illustrating the realities of its implementation
and the differences between member states' interpretation |
| Dr. Christopher Bravery
(speaker) |
|
| 2008
9 - 10 December
London, UK |
| Genesis 2008 |
| Adding
value to biotech product development from the
regulatory perspective |
| Dr.
Chris Holloway (speaker) |
|
| 2008
2 - 3 December
Brussels,
Belgium |
| Informa Vaccine Scale-up
and Manufacturing |
| Scale-up
in manufacturing and the development of a commercial
process:
The
regulatory implications |
| Dr.
David Kirke (speaker) |
|
| 2008
26 -29 October
Melbourne,
Australia |
| AusBiotech 2008 |
| Investing in Cell Therapies in Australia
- From Benchtop to Patient |
| Dr.
Dianne Jackson-Matthews (speaker) |
|
| 2008
20 - 22 October
Mumbai, India |
| IBC's BioProcess International,
Asia Pacific |
| Pre-conference Summit: "Developing
Your Biosimilar Strategy for the International Market" |
| Dr.
Dianne Jackson-Matthews (chairperson) |
| |
| Biosimilar Medicines, Science and
Regulation for Development and Approval |
| Dr.
Dianne Jackson-Matthews (speaker) |
|
| 2008
14 -15 October
Brussels,
Belgium |
| Informa Biological Assays |
| Bioassay development from the regulatory
perspective |
| Dr.
Deirdre McIntosh (speaker) |
|
| 2008
9 October
Tokyo, Japan |
| World Courier Global
Clinical Trial Management and Logistics |
| Biotechnology companies and the FDA
- getting your trials up and running in the US |
| Dr.
Dianne Jackson-Matthews (speaker) |
|
| 2008
7 - 9 October
Paris, France |
| EuroBiO 2008 |
| Regulatory
session
'Agency
Interactions in Europe: Best Practice' |
| Dr.
Chris Holloway (chair and speaker) |
|
| 2008
6 - 8 October
Budapest,
Hungary |
| TOPRA 5th Annual Symposium
2008 |
| Regulating Novel Technologies |
| Dr.
Christopher Bravery (speaker) |
|
2008
22 - 24 September
Bethesda,
USA |
| ISCT 8th Annual Somatic
Cell Therapy Symposium |
Challenges
of international studies from the regulatory and
business perspectives:
A regulatory
overview highlighting the regulatory frameworks
in the US, Europe and Asia |
| Dr.
Christopher Bravery (Panelist and speaker) |
|
| 2008
7 - 9 August
Brisbane,
Australia |
| Clinical Research Excellence
2008 |
| Research, Education & Ethics |
| Dr.
Dianne Jackson-Matthews (chair) |
| |
| Strategy & Regulations: Preparing
for Clinical Trials |
| Dr. Dianne Jackson-Matthews
(speaker) |
|
| 2008
22 - 26 June
Boston, USA |
| DIA 2008 |
| Comparability of Biopharmaceuticals |
| Dr.
Chris Holloway (speaker) |
|
| 2008
17 - 21 June
San Diego,
USA |
| BIO 2008 |
| QTCN Session: Regulatory challenges
and solutions in Asia-Pacific |
| Dr.
Chris Holloway (speaker) |
|
| 2008
21 - 24 April
Vienna, Austria |
| Informa BPI 2008 |
| Regulatory comparability safety strategy
for biosimilars and for change implementation |
| Dr.
Chris Holloway (co-speaker) |
|
| 2008
07- 10 April
Barcelona,
Spain |
| 6th World Meeting on
Pharmaceutics, Biopharmaceutics and Pharmaceutical
Technology |
| The regulatory landscape for similar
biological medicinal products in the EU and US:
comparisons, contrasts and challenges |
| Dr.
Chris Holloway (speaker) |
|
| 2008
28 - 30 January
Washington
DC, USA |
| Phacilitate Vaccine/C&G
Forum 2008 |
| What are the key trends in the ongoing
evolution of the global regulatory environment for
cell and gene therapies? |
| Dr.
Chris Holloway (chair) |
| |
| Impact and consequences of the evolving
regulatory framework for cell and gene therapy products
from the industry perspective |
| Dr. Chris Holloway (speaker) |
|
| 2007
29 November -01 December
Margaret River,
Australia |
| ABTRF |
| Update on the Regulation of Advanced
Therapies in Europe |
| Dr.
Dianne Jackson-Matthews (speaker) |
|
| 2007
13 - 14 November
Prague, Czech
Republic |
| Informa's Stability
Testing for Biologics |
| EU Regulation of Medicinal Products:
Product Stability Issues and Post-approval Commitments |
| Dr.
Niamh Kinsella (speaker) |
|
| 2007
05 - 07 November
Lyon, France |
| European Antibody 2007 |
| Nonclinical safety Assessment for
Antibodies |
| Dr.
Patrizia Nestby (speaker) |
|
2007
29-30 October
Melbourne,
Australia
Educational
Division of the ERA Consulting Group |
| intERActions Seminar |
| The Regulatory Procedures for Pharmaceuticals
in the United States and Europe: Introductory Course
with Special Emphasis on Biopharmaceuticals |
Dr.
Chris Holloway
Dr.
Dianne Jackson-Matthews |
| |
| For more information on this event
and how to register please click
here |
|
| 2007
21 - 24 October
Brisbane,
Australia |
| AusBiotech 2007 |
| Regulatory Issues in Drug Discovery"
session. His presentation: "Optimising the
value of early-stage drug discovery and development
for the global market - from the regulatory perspective" |
| Dr.
Chris Holloway (speaker) |
|
| 2007
10- 11 October
Hamburg, Germany |
| IBC's Early Development
Of Therapeutics |
| Adding value to the development of
biotechnology-derived medicinal products from the
European regulatory perspective |
| Dr.
Chris Holloway (speaker) |
|
| 2007
30 September -04 October
Boston, USA |
| BPI 2007 |
| Overcoming the Regulatory Challenges
in Development of Biosimilar Medicines |
| Dr.
Dianne Jackson-Matthews (speaker) |
|
| 2007
25 - 28 September
Lille, France |
| EuroBio 2007 |
| Adding value to the development of
biotechnology-derived medicinal products from the
European regulatory perspective |
| Dr.
Chris Holloway (speaker) |
|
| 2007
24 - 26 September
Singapore |
| BioPharm Asia 2007 |
| Pre-conference Masterclasses: "Overcoming
the Regulatory Challenges in Development of Biosimilar
Medicines" |
| Dr.
Dianne Jackson-Matthews (speaker) |
| |
| Conference 2: Biosimilars: Taking
Follow-on Biologics to Market |
| Dr.
Dianne Jackson-Matthews (chairperson) |
|
| 2007
19 - 20 September
London, UK |
| SMi's Biologics Conference |
| Adding Value to Biotech Product Development
from the EU Regulatory Perspective |
| Dr.
Niamh Kinsella (speaker) |
|
| 2007
11 - 13 September
Geneva, Switzerland |
| Terrapin's BioPharm
Scale-up |
| Demonstrating Comparability Following
Scale-up: A Focus on Therapeutic Antibody Products |
| Dr.
Richard Turner (speaker) |
|
2007
18 - 20 July
Washington,
DC. USA
Educational
Division of the ERA Consulting Group |
| intERActions Seminar |
| The Basics of Regulatory Affairs in the Context
of Product Development with Special Emphasis on
Biopharmaceuticals and Advanced Therapy Medicinal
Products |
Dr.
Chris Holloway
Dr.
Dianne Jackson-Matthews |
| |
| For more information on this event
and how to register please click
here |
|
| 2007
17 - 21 June
Atlanta, USA |
| DIA 2007 |
| Legal and regulatory status of similar/comparable
biological medicinal products in Europe and the
United States: Key similarities/differences |
| Dr.
Chris Holloway (chair and speaker) |
| |
| Pitfall of process changes during
biotech product development from the CMC perspective |
| Dr.
Chris Holloway (speaker) |
|
2007
04 - 06 June
Syndey, Australia |
| ARCS 2007 Annual Scientific
Congress |
| Demystifying the European and US
Regulatory Markets |
| Dr.
Dianne Jackson-Matthews (speaker) |
| |
| Regulation of Biopharmaceuticals
in Australia |
| Dr.
Dianne Jackson-Matthews (speaker) |
|
2007
31 May - 01 June
Munich, Germany |
| Phacilitate Vaccine Forum
Munich 2007 |
| Regulatory perspective: Clarifying
approaches to Marketing Authorisation in the EU
of vaccines derived from novel manufacturing technologies |
| Dr.
Chris Holloway (speaker) |
|
2007
24 - 26 April
Paris, France |
| BioProcess International
2007 |
| Recent developments relating to the
regulation of 'comparable biological products' in
the United States |
| Dr.
Chris Holloway (speaker) |
| |
| Workshop on 'Managing Biopharmaceutical
CMC Changes from the Regulatory Perspective' |
| Dr.
Chris Holloway (speaker) |
|
2007
16 - 18 April
London, UK |
| Life Science World Alliance
2007 |
| Adding value to biotech product development
from the European regulatory perspective |
| Dr.
Chris Holloway (chair and speaker) |
|
2007
26- 28 March
Vienna, Austria |
| DIA Euromeeting 2007 |
| Regulatory workshop: Comparability
of BioPharmaceuticals |
| Dr.
Richard Turner (speaker) |
|
2007
22 March
Melbourne,
Australia |
| BioMelbourne Workshop |
| Understanding Regulatory Afairs in
the Austrlian, US and European Markets |
| Dr.
Dianne Jackson-Matthews (invited speaker) |
|
2007
08 - 09 March
Brussels,
Belgium |
| CMC Strategy Forum Europe
2007 |
| Action Limits and their application
in the context of Process Specifications |
| Dr.
Chris Holloway (chair and speaker) |
|
2007
22 - 24 January
Baltimore,
USA |
| Phacilitate Cell &
Gene Therapy Forum 2007 |
| Opportunities within the new European
regulatory framework for Advanced Therapy Products |
| Dr.
Chris Holloway (speaker) |
| |
| Regulatory workshop: Navigating the
European regulatory mechanisms for Advanced Therapy
Products |
| Dr.
Chris Holloway (speaker) |
| Dr. Richard Turner (speaker) |
|
2006
04 - 06 December
Lyon, France |
| European Antibody congress |
| CMC Challenges During Clinical Development
of Human Antibodies |
| Dr.
Richard Turner (invited speaker) |
|
2006
23 - 24 November
Singapore |
| Generics - Asia |
| Biosimilar Medicines: A Trivial Pursuit,
or more? |
| Dr.
Dianne Jackson-Matthews (invited speaker) |
|
2006
07 - 08 November
Basel, Switzerland |
| IBC's Post-Translational
Modifications |
| Regulatory Perspective on Post-Translational
Modifications |
| Dr.
Richard Turner (invited speaker) |
|
2006
23 - 25 October
Brisbane,
Australia |
| Australian Clinical Research |
| Australian Clinical Research and the
FDA |
| Dr.
Dianne Jackson-Matthews (invited speaker) |
|
2006
20 October
Melbourne,
Australia |
| World Courier Conference |
| 1Biotech and the FDA: Getting Clinical
Trials Going in the US |
| Dr.
Dianne Jackson-Matthews (invited speaker) |
|
2006
09 - 11 October
Lyon, France |
| World Vaccine Congress
2006 |
| Regulatory and Product Development
Issues Associated with DNA Vaccines: Development
to Marketing Approval |
| Dr.
Niamh Kinsella (invited speaker) |
|
2006
03 - 05 October
London, UK |
| Cancer Vaccine Development
2006 |
| Pre-conference Workshop: Regulatory
Considerations in the Development of Cancer Vaccines |
| Dr.
Niamh Kinsella (Chair) |
| Dr. Allison Wyndham
(Speaker) |
|
2006
28 September
London, UK |
| Seminar at the London
Bioscience Innovation Centre |
| Adding Value to Early Stage Biotech
Product Development from the Regulatory Perspective |
| Dr.
Chris Holloway (speaker) |
| Dr. Richard Turner (speaker) |
| Dr. Niamh Kinsella (speaker) |
|
2006
13 - 14 September
London, UK |
| PABORD 2006 |
| New opportunities for small biotech
enterprises from the regulatory perspective |
| Dr.
Chris Holloway (speaker) |
|
| 2006
30 June
Zurich, Switzerland |
| IBC’s Congress
on Recombinant Antibodies Forum 2006 |
| Regulations in the Global Antibody
Market |
| Dr.
Chris Holloway (speaker) |
|
| 2006
29-30 June
Zurich, Switzerland |
| IBC’s Follow On
Biologics |
| General Regulatory and Legal Environment |
| Dr.
Chris Holloway (chair and speaker) |
|
2006
27-28 June
Zurich, Switzerland |
| IBC’s Comparability
for Biologics |
| Impact of scale-up, post-translational
modification, and process change on product characteristics
and on safety, efficacy and stability |
| Dr.
Chris Holloway (speaker) |
|
2006
19 - 22 June
Amsterdam,
the Netherlands |
| bioLOGIC Europe 2006 |
| Manufacturing issues: Practicability |
| Dr.
Richard Turner (invited speaker)
|
| |
| Adding value to early stage clinical
development of biologics within the framework of
the Directive |
| Dr. Niamh Kinsella (invited
speaker) |
|
2006
18 - 22 June
Philadelphia,
PA, USA |
| DIA 2006 |
| Understanding the Regulation of Advanced
Therapy Medicinal Products in Europe |
| Dr.
Chris Holloway (Chair) |
| |
| Practical Application of Scientific
Advice in the Development of Biologics |
| Dr. Chris Holloway (Chair)
|
| |
| Requesting and Obtaining Scientific
Advice in the European Union from Member State Agencies |
| Dr. Dianne Jackson-Matthews
(invited speaker) |
|
2006
05 - 07 June
Sydney, Australia |
| ARCS 2006 Annual Scientific
Congress |
| Regulatory Intelligence |
| Dr.
Dianne Jackson-Matthews (invited speaker) |
|
2006
16 - 17 May
Vienna, Austria |
| DIA - European Regulatory
CMC workshop |
| European Regulatory CMC - An Overview |
| Dr.
Richard Turner (speaker) |
|
2006
04-07 May
Berlin, Germany |
| ISCT 2006 |
| Regulatory Strategies for Early-Stage
Development of Cell Therapy Products |
| Dr.
Chris Holloway (keynote speaker) |
|
| 2006
26 - 27 April
Anaheim, CA,
USA |
| PDA 2006 Process Validation
|
| European viewpoint on process validation
comparability |
| Dr.
Chris Holloway (invited speaker) |
|
| 2006
05 - 07 April
Cambridge,
UK |
| IBC Biopharmaceutical
Spring School |
| Preclinical and Clinical Development |
| Dr.
Richard Turner (invited speaker) |
|
2006
24 March
Heidelberg,
Germany |
| DIEVINI Spring meeting |
| Adding Value to Early-Stage Biotech
Product Development from the European Regulatory
Perspective |
| Dr.
Chris Holloway (speaker) |
|
2006
20 - 23 March
Washington,
DC. USA |
| World Vaccine Congress
2006 |
| Regulatory pitfalls in early stage
development of therapeutic vaccines |
| Dr.
Niamh Kinsella (invited speaker) |
|
| 2006
06 - 08 March
Paris, France |
| EuroDIA 2006 |
| Workshop on "Similar Biological Medicinal Products"
|
Dr.
Chris Holloway (workshop chair) |
| |
| Comparability - Evaluating and Making Manufacturing
Changes for Biotech Products. |
| Dr. Chris Holloway (invited
speaker ) |
|
| 2006
23 February
Basel, Switzerland |
| ECPM Workshop |
| Workshop on " The Latest on Biologicals and Biosimilars"
|
Dr.
Chris Holloway (invited speaker) |
|
| 2006
30 January - 01 February
Baltimore,
MD, USA |
| Phacilitate Vaccine / Cell and Gene
Therapy Forum |
| Addressing the latest regulatory challenges for
cell and gene therapies in North America and Europe.
|
Dr.
Chris Holloway (Chair) |
| |
| Update on the European regulation of cell therapy
and gene therapy medicinal products |
| Dr Chris Holloway (Co-Moderator) |
|
| 2005
08 - 09 December
Goettingen,
Germany |
| Plenary ACTIP Meeting |
| The Global View of Similar Biological Medicinal
Products - Scientific and Legal Issues |
Dr. Chris
Holloway (invitied speaker) |
|
2005
24 - 26 November
Margaret River,
Australia |
| Second Australian Biotherapeutics
and Tissue Regeneration |
| Regulatory Renovations in the US and Europe:
Making space for cell/gene/tissue therapies |
Dr.
Dianne Jackson-Matthews (invited speaker) |
|
2005
21 - 23 November
Perth, Australia |
| AusBiotech 2005 Annual Conference
and Exhibition |
| Regulatory Harmonisation in Europe - opportunities
and challenges for the biotech industry |
Dr.
Chris Holloway |
|
2005
16 November
Brisbane, Australia
Educational
Division of the ERA Consulting Group |
| intERActions Seminar |
| EU Regulatory Update |
Dr.
Chris Holloway
Dr.
Dianne Jackson-Matthews |
| |
| For more information of these events
and how to register please click
here |
|
2005
15 November
Sydney, Australia
Educational
Division of the ERA Consulting Group |
| intERActions Seminar |
| EU Regulatory Update |
Dr.
Chris Holloway
Dr.
Dianne Jackson-Matthews |
| |
| For more information of these events
and how to register please click
here |
|
2005
14 November
Melbourne,
Australia
Educational
Division of the ERA Consulting Group |
| intERActions Seminar |
| EU Regulatory Update |
Dr.
Chris Holloway
Dr.
Dianne Jackson-Matthews |
| |
| For more information of these events
and how to register please click
here |
|
2005
24-27 October
Amsterdam, The Netherlands |
| BioProduction 2005 |
| Validating the clearance of product- and process-related
impurities |
| Dr. Chris Holloway (invited
speaker |
|
2005
17-19 October
Baltimore,
MD, USA |
| RAPS 2005 |
| Seeking Scientific Advice: Experiences in the
US And Europe |
| Dr. Dianne Jackson-Matthews (session
chairperson ) |
| Dr. Chris Holloway (invited
speaker) |
| |
| Comparability exercises for biologics in pre-
and post-approval scenarios from the European perspective |
| Dr. Chris Holloway ( invited
speaker) |
|
2005
14-15 September
London, UK |
| PABORD 2005 |
| Adding Value to Early Stage Biotech Product Development
from the Regulatory Perspective |
| Dr. Chris Holloway ( invited
speaker) |
|
2005
08 September
Zurich, Switzerland |
| PFC Regulatory Forum on Biosimilar
Medicinal Products |
| Case studies in comparability of biological medicinal
products: Consequences for products claimed to be
similar to another one already marketed |
| Dr. Chris Holloway ( invited
speaker) |
|
2005
18-19 July
New York City,
USA |
| IIR CMC EU Clinical Trials CTD Conference |
| Overcoming CTD Content Conversion Challenges |
| Dr. Dianne Jackson-Matthews (invited
workshop speaker) |
| |
| The EU Clinical Trials Directive- the New CMC
Submission Requirements |
| Dr. Dianne Jackson-Matthews (invited
workshop speaker) |
|
2005
26-30 June
Washington,
DC, USA |
| DIA 2005 |
| Case studies in comparability of biological medicinal
products: Consequences for products claimed to be
similar to another one already marketed |
| Dr. Chris Holloway (invited
speaker) |
|
2005
01-03 June
London, UK |
| IIR Follow-on Biologics |
| Challenges in comparability: from innovator to
follow-on biologic |
| Dr. Chris Holloway (invited
workshop speaker) |
|
2005
24-25 May
London, UK |
| IIR Scientific Advice 2005 |
| Preparations for Scientific Advice |
| Dr. Allison Wyndham (invited
speaker) |
|
2005
23-26 May
Geneva, Switzerland |
| bioLOGIC 2005 |
| Adding value to early stage clinical development
of biologics within the framework of the Directive |
| Dr. Chris Holloway (invited
speaker) |
|
2005
19 May
London, UK |
| BIA BioBusiness Exchange 2005 |
| Adding value to early stage biotech product development
|
| |
| Constructive regulatory affairs strategies for
biotech product development |
| |
| Regulatory intelligence in the light of rapidly
evolving regulatory requirements |
| |
| Route map to regulatory success in the development
of a biotech product |
| |
| Dr. Chris Holloway (invited
speaker) |
|
2005
01-02 March
Brussels,
Belgium |
| IBC Follow-on Biologics Conference |
| Follow-on biologics: an unrecognised minefield |
| Dr. Chris Holloway (invited
speaker) |
| |
| Risk-analysis of follow-on biologic: factors to
consider |
| Dr. Chris Holloway (invited
panellist) |
|
2005
24-26 January
Washington, DC, USA |
| Phacilitate Gene Forum |
| Cell therapy and tissue engineering regulation
in North America and Europe |
| Dr. Chris Holloway (invited
speaker) |
| |
| Cell and tissue therapy product development and
manufacture |
| Dr. Chris Holloway (invited
speaker) |
|
2004
6-7 December
Reston, VA, USA |
| IBC Global Follow-On Biologics Conference |
| Issues in the Globalization of Follow-On Biologics |
| Dr. Chris Holloway (invited
speaker) |
|
2004
17-19 November
Singapore |
| bioLOGIC Asia 2004 |
| Current Regulatory Approaches to Biogeneric Products
in the US and Europe and Consequences from Products
Developed in Asia |
| Dr. Dianne Jackson-Matthews (invited
speaker) |
| |
| The Current Status of European Regulations and
Directives Relating to Biologics |
Dr.
Dianne Jackson-Matthews (invited workshop
speaker)
Dr. Chris
Holloway (invited workshop speaker)
Dr.
Allison Wyndham (invited workshop speaker) |
|
2004
16 November
Melbourne,
Australia
Educational
Division of the ERA Consulting Group |
| ARCS/AusBiotech Co-sponsored Seminar
|
| The current status of European regulations and
directives relating to biotech/biologics |
Dr.
Dianne Jackson-Matthews
Dr.
Allison Wyndham
Ms
Cathy Cropp, Senior Consultant, SeerPharma Pty
Ltd |
| |
| Click
here for registration forms |
|
2004
15 November
Sydney, Australia
Educational
Division of the ERA Consulting Group |
| ARCS/AusBiotech Co-sponsored Seminar
|
| The current status of European regulations and
directives relating to biotech/biologics |
| Dr.
Dianne Jackson-Matthews
Dr.
Allison Wyndham
Dr
Steve Williams, Director, SeerPharma Pty Ltd |
| |
| Click
here for registration forms |
|
2004
7-10 November
Brisbane,
Australia |
| AusBiotech 2004 Annual Conference
and Exhibition |
| Rational Approaches to the Preclinical Phase of
Biotech Product Development |
| Dr. Chris Holloway (invited
speaker) |
| |
| Secrets of a Successful IND Meeting: What Can
Go Wrong in a pre-IND/IND Process |
| Dr. Dianne Jackson-Matthews (invited
speaker) |
|
2004
2-5 November
Cambridge,
MA, USA
Educational
Division of the ERA Consulting Group |
| Phacilitate Fall Conference |
| Preparing Your Organisation for Clinical Development
on a Global Scale |
Dr.
Chris Holloway (invited workshop speaker)
Dr.
Allison Wyndham (invited workshop speaker) |
|
2004
27-28 October
London, UK |
| IIR Conference "Comparability
Testing" |
| An Overview of the Current FDA Guidelines for
Biocomparability Issues - a US Perspective |
| Dr. Chris Holloway (invited
speaker) |
|
2004
10-13 October
Washington,
DC, USA |
| RAPS 2004
Annual Conference and Exhibition |
| The Changed Regulatory Environment for Biologics
in the EU |
Dr.
Chris Holloway (invited speaker) |
|
| 2004
14-15 September
Rockville,
MD, USA |
| FDA Public
Workshop: Scientific Considerations Related to Developing
Follow-on Protein Products |
| Comparability Exercises: Limitations for Follow-on
Biologics (FBOs) - The European Perspective |
| Dr. Chris Holloway (invited
speaker) |
|
| 2004
8-10 September
Philadelphia,
PA, USA |
| Barnett
Biopharmaceutical Comparability Conference |
| Comparability in the European Union: Regulatory
and Scientific Approaches |
| Dr. Dianne Jackson-Matthews (invited
speaker) |
| |
| Developments in the European Union on Biosimilar
Medicinal Products: Defining the Genre |
Dr.
Dianne Jackson-Matthews (invited speaker) |
|
2004 22-24
June
Geneva, Switzerland |
| bioLOGIC Conference 2004 |
| Meeting the Regulatory Challenge of Releasing
Clinical Trial Material into Europe in Light of
the New EU Clinical Trials Directive. |
| Ms. Philippa Whiteside (invited
speaker) |
|
2004 8-9
June
Berlin, Germany |
| IBC Conference “Comparability and
Immunogenicity of Biologicals” |
| Regulatory Viewpoint in the US on Comparability
and Immunogenicity |
| Dr. Dianne Jackson-Matthews (invited
speaker) |
|
2004 10-13
May
Amsterdam, The Netherlands |
| Phacilitate Spring Vaccine Forum |
| Chair person's intro: Vaccines within the Context
of Biological Medicinal Products: Regulatory Developments
in the European Union |
| Dr. Chris Holloway (invited
chair) |
| |
Workshop: Understanding and Complying with the
EU Clinical Trial
Directive: A Practical Guide for Vaccine Companies |
Dr. Chris Holloway (invited
workshop moderator)
Dr. Allison Wyndham (invited workshop moderator) |
|
2004 15-17
March
La Jolla, CA |
| IBC Conference “Manufacturing Off-Patent
Biologics” |
| Off-Patent Biologics Product Comparability: How
Similar Is Similar Enough? |
| Dr. Dianne Jackson-Matthews (invited
speaker) |
| |
| Keynote address: The European View on Similar
Biological Products: Scientific and Regulatory Considerations |
| Dr. Chris Holloway (invited
speaker) |
| |
Panel Discussion: Divining a Regulatory Framework
for Off-Patent Biologics |
Dr. Dianne Jackson-Matthews (invited
moderator)
Dr. Chris Holloway (invited participant) |
|
2004 9-12
March
Prague, Czech Republic |
| DIA EuroMeeting 2004 |
| CMC Challenges in Early Preclinical and Clinical
Development |
| Dr. Chris Holloway (invited
speaker) |
|
2004 26-27
February
Philadelphia, PA , USA |
| IIR Seminar “EU Clinical Trials Directive” |
| Determining the Implications of the EU Clinical
Trials Directive for Biotech and Biological Product
Development and Research |
| Dr. Dianne Jackson-Matthews (invited
speaker) |
|
2004 23-24
February
San Diego, CA, USA |
| IBC Conference ”Process Validation
for Biologicals” |
| Europe: Review of the European Approach to Comparability |
| Dr. Dianne Jackson-Matthews (invited
speaker) |
|
2003 2-4
December
Vienna, Austria |
| CORDIA EuropaBio Convention 2003 |
| Interacting with Regulators in Europe & the
United States – Comparing the “Scientific Advice”
Systems for Biotech Products |
| Dr. Chris Holloway (speaker) |
|
2003 10-12
November
Washington, DC, USA |
| IIR International Clinical Trials
Conference |
| Introduction to the EU Clinical Trials Directive
and how it Impacts Clinical Trials Processes workshop |
| Dr. Dianne Jackson-Matthews (invited
workshop leader) |
|
2003 22-23
October
Reston, VA, USA |
Strategic Research Institute
Generic Biopharmaceuticals conference |
| Biogenerics in Europe: The Ultimate Fata Morgana |
| Dr. Chris Holloway (invited
speaker) |
| |
| Biogeneric Products in Europe: Resolving the Mirage? |
| Dr. Dianne Jackson-Matthews (invited
speaker) |
|
2003 19-22
October
Baltimore, MD, USA |
| RAPS 2003 Annual Conference and Exhibition |
| Session: Understanding the Clinical Trials Directive |
Dr. Chris Holloway (invited
speaker)
Dr. Dianne Jackson-Matthews (invited speaker
and chairperson) |
| |
| Session: Challenges in Medicinal Product Approval
in Europe: Case Studies for Biotech Products |
Dr. Chris Holloway (invited
speaker and chairperson)
Dr. Dianne Jackson-Matthews (invited speaker) |
| |
|
2003 30 September
– 1 October Amsterdam,
The Netherlands |
| IIR Conference "Immunogenicity
of Protein-based Therapeutics" |
| Regulatory considerations - US viewpoint |
| Dr. Dianne Jackson-Matthews (invited
speaker) |
|
2003 29 -
30 September
Lyon, France |
| World Vaccine Congress 2003 |
| Easing the Regulatory Process |
| Ms. Philippa Whiteside (invited
moderator) |
| |
| Strategies for Implementing Compliant Solutions
for CTD and eCTD Submissions |
| Ms. Philippa Whiteside (invited
speaker) |
|
2003 1 September
Sydney, Australia
Educational Division of the ERA Consulting Group
|
| ARCS sponsored seminar |
| Update and Trends in the Regulation of Biopharmaceutical
Products in Europe |
| Dr. Chris Holloway (invited seminar
instructor) |
|
2003 22
August
Brisbane, Australia
Educational Division of the ERA Consulting Group
|
| AusBiotech/ARCS sponsored seminar
|
| Adding Value to Early Stage Biotech Product Development |
Dr. Chris Holloway (invited
seminar instructor)
Dr. Dianne Jackson-Matthews (invited seminar
instructor)
Dr. Allison Wyndham (invited seminar instructor) |
| |
| Overview of Importance of Early Stage Planning
– Issues in CMC Development |
| Dr. Chris Holloway |
| |
| Issues in pre-Clinical Development |
| Dr. Allison Wyndham |
| |
| Issues Relating to Clinical Development |
| Dr. Dianne Jackson-Matthews |
| |
| Case Studies and Summary |
Dr. Chris Holloway
Dr. Dianne Jackson-Matthews |
|
2003
20 August
Melbourne, Australia
& 21 August
Brisbane, Australia
Educational Division of the ERA Consulting Group
|
| AusBiotech/ARCS sponsored seminar |
| Cell therapy products - concepts for their development
and regulation |
Dr. Chris Holloway (invited
seminar instructor)
Dr. Dianne Jackson-Matthews (invited seminar
instructor)
Dr. Allison Wyndham (invited seminar instructor) |
| |
| Advanced Cell and Tissue Therapy Products in Europe
and the USA: Legislation and Oversight |
| Dr. Allison Wyndham |
| |
| Advanced Cell and Tissue Therapy Products in Europe
and the USA: Regulatory Procedures |
| Dr. Dianne Jackson-Matthews |
| |
| Product Development Issues Relating to Quality
and Safety |
| Dr. Chris Holloway |
| |
| Case Studies in Cell and Tissue Product Development |
Dr. Chris Holloway
Dr. Dianne Jackson-Matthews |
|
2003 16-19
August
Adelaide, Australia |
| AusBiotech 2003 Annual Conference
and Exhibition |
| Developing Successful Manufacturing Strategies
for Biopharmaceutical Products |
| Dr. Chris Holloway (invited
speaker) |
| |
| Case Studies in Outsourcing – A Critical View
of Experience in the USA and Europe |
| Dr. Dianne Jackson-Matthews (invited
speaker) |
|
2003 4-6
June
Geneva, Switzerland |
| bioLOGIC Conference 2003 |
| Achieving Regulatory Compliance |
| Dr. Chris Holloway (moderator) |
| |
| Enhancing the Development of Cutting Edge Biological
Products Using Regulatory Intelligence |
| Ms. Philippa Whiteside (speaker) |
|
2003 19-22
May
Amsterdam,
The Netherlands |
| Phacilitate Spring Vaccine Forum |
| Pre-conference workshop: Adapting the CTD for
a Vaccine |
Dr. Chris Holloway (workshop
leader and speaker)
Ms. Philippa Whiteside (speaker) |
|
2003 8-9
May
Bethesda, MD, USA |
| IBC Well Characterized Biologicals
conference |
| The European Perspective on Comparability for
Biologics |
| Dr. Dianne Jackson-Matthews (invited
speaker) |
| |
| The Role of Comparability Studies in Risk Assessment
of Biological Products |
| Dr. Chris Holloway (invited
speaker) |
|
2003 29-30
April
London, UK |
| IPQC Preparing for Compliance with
the EU Clinical Trials Directive |
| Analysing and Interpreting the Provisions in the
Directive Relating to Biotechnology Product Development
and Research |
| Ms. Philippa Whiteside (invited
speaker) |
|
2003 20-21
March
London, UK |
| RAPS Discussion Forum: Development
and Regulation of Cell-Based Therapies |
| Dr. Chris Holloway (program
co-chair) |
|
2003 5-7
March
Rome, Italy |
| DIA EuroMeeting 2003 |
| Concepts and Limitations of Comparability for
post-Patent Biopharmaceutical Products |
| Dr. Chris Holloway (invited
speaker) |
|
2003 25-26
February
London, UK |
| IBC EU Clinical Trials Directive
Conference |
| Implementation workshop: Audience participation
– Exchanging Directive Problems that have been Encountered |
| Dr. Dianne Jackson-Matthews (workshop
leader) |
|
2002
11-12 Dec
Washington, DC, USA
Educational Division of the ERA Consulting Group
|
| IBC Professional Development Course |
| Understanding the European Regulation of Biological
Medicinal Products |
Dr. Chris Holloway (course instructor)
Dr. Dianne Jackson-Matthews (course instructor) |
|
2002 9 December
Bethesda, MD, USA |
| IBC Multi-Source Biologics Conference |
| Interactive pre-conference symposium (half day) |
Dr. Chris Holloway (invited
workshop leader)
Dr. Dianne Jackson-Matthews (invited workshop
leader) |
| |
| Characterization: When can it be used to demonstrate
comparability? Pros and Cons |
| Dr. Dianne Jackson-Matthews (chairperson) |
| |
| Comparability and multisource biotech products
from the European perspective |
| Dr. Chris Holloway (speaker) |
| |
| Characterization and Comparability – panel discussion |
Dr. Dianne Jackson-Matthews (panellist)
Dr. Chris Holloway (panellist) |
|
2002 6-9
October
Washington, DC, USA |
| RAPS Annual Conference and Exhibition |
| Pre-conference workshop (organised by ERA Consulting
Group): Transatlantic Biotech Products: The challenges
in creating the quality section of the CTD |
Dr. Chris Holloway (session
leader)
Dr. Dianne Jackson-Matthews (speaker)
Ms. Philippa Whiteside (speaker) |
|
2002
30 September –
2 October
Lyon, France |
| World Vaccine Congress |
| US and European regulation harmonisation: Avoiding
the production bottlenecks |
| Dr. Chris Holloway (speaker) |
| |
| Panel Session: Global vaccine regulation – the
future for vaccine regulation and co-operation |
| Dr. Chris Holloway (invited
panellist) |
|
2002 22 August
Melbourne, Australia
& 23 August
Sydney, Australia |
| AusBiotech 2002 |
| Regulatory Affairs Symposium |
| |
| Current international regulatory expectations
for the development of biotechnology-derived pharmaceutical
products |
Dr. Chris Holloway (chairperson
and speaker)
Dr. Dianne Jackson-Matthews (speaker) |
| |
| Overview of Regulatory Procedures for medicinal
products in the European Union – The present and
the future |
| Dr. Chris Holloway (speaker) |
| |
| Overview of regulatory procedures for medicinal
products in the USA: Biotech and beyond |
| Dr. Dianne Jackson-Matthews (speaker) |
| |
| Points to Consider in early-stage development
of biotech and biological products |
| Dr. Chris Holloway (speaker) |
| |
| Issues of Comparability during early stage development
of biologic/biotech products: Regulatory consequences |
| Dr. Dianne Jackson-Matthews (speaker) |
| |
| Adding Value to early-stage biotech drug development
with regard to regulatory considerations |
| Dr. Chris Holloway (speaker) |
| |
Regulatory Approaches to clinical trials in the
USA and Europe:
Impact of the new European clinical trials Directive |
| Dr. Dianne Jackson-Matthews (speaker) |
|
2002 5-7
June
Geneva, Switzerland |
| bioLOGIC Conference 2002 |
| Biotech manufacturing – convergence of biotech
and pharma? Panel Discussion |
| Dr. Chris Holloway (invited
panellist) |
| |
| Advanced therapy medicinal products: New regulatory
perspectives in Europe |
| Dr. Chris Holloway (invited
speaker) |
|
2002 13-16
May
Paris, France |
| Phacilitate Spring Vaccine Forum |
| Roundtable Discussion: “Key regulatory challenges
involved in variations and clinical trials and identifying
potential solutions” |
| Dr. Chris Holloway (invited
moderator) |
| |
| Regulatory Aspects of cancer vaccines |
| Dr. Chris Holloway (invited
speaker) |
|
2002 7-10
May
Budapest, Hungary |
| EuroRAPS 2002 |
| Compiling the Quality sections of a Common Technical
Document for a biotech or biological product |
Dr Chris Holloway (session leader
and speaker)
Ms. Philippa Whiteside (speaker) |
| |
| Update on regulatory expectations for TSE matters |
| Dr. Chris Holloway (speaker) |
| |
| European regulatory framework |
| Dr. Chris Holloway (invited
speaker) |
| |
| Compiling the quality sections of a Common Technical
Document for a biotech or biological product |
Dr Chris Holloway (session leader
and speaker)
Ms. Philippa Whiteside (speaker) |
| |
| Future of biomedicine and regulation – Plenary
session |
| Dr. Chris Holloway (invited
speaker) |
|
2002 6-8
May
Las Vegas, USA |
| IBC TIDES 2002 |
| European regulatory expectations |
| Dr. Dianne Jackson-Matthews (invited
speaker) |
| |
| Co-moderation of Focus group |
| Dr. Dianne Jackson-Matthews (invited,
with Dr. Chien-Hua Niu, FDA) |
|
2002 5-8
March
Basel, Switzerland |
| EuroDIA 2002 |
| Biogenerics and comparability – Panel discussion |
| Dr. Chris Holloway (invited
panellist) |
|
2002 13-18
January
Harriman, NY, USA |
AAPS
Annual Pharmaceutical Technology Conference |
| European regulatory aspects of biological product
dosage forms |
| Dr. Chris Holloway (invited
speaker) |
|
2002 15-16
January
Alexandria, VA, USA |
| RAPS Global Awareness Conference |
| Recent developments in biologics/biotechnology
regulations |
| Dr. Chris Holloway (speaker) |
| |
| Regional harmonisation of standards for drugs
and biologics in Europe |
| Dr. Dianne Jackson-Matthews (speaker) |
| |
| TSE regulations |
| Dr. Chris Holloway (speaker) |
| |
| How to fulfil TSE regulations |
| Dr. Dianne Jackson-Matthews (speaker) |
|
2001 6-7
December
Hamburg, Germany |
| IBC Oligonucleotide and Peptide Conference |
| How to get your biotech product approved in Europe |
| Dr. Chris Holloway (invited
speaker) |
|
2001 5-7
November
Baltimore, MD, USA |
| RAPS Annual Conference and Exhibition |
| Recent CMC developments |
| Dr. Dianne Jackson-Matthews (session
chairperson) |
| |
| CMC developments as a result of ICH |
| Dr. Dianne Jackson-Matthews (speaker) |
| |
| Issues of comparability from the European perspective |
| Dr. Chris Holloway (speaker) |
| |
| Overview of the current situation in the EU relating
to the use of materials of ruminant animal origin
in medicinal products and production processes,
with respect to minimising the risk associated with
TSE |
| Dr. Chris Holloway (speaker) |
|
2001 18-19
October
Bethesda, MD, USA |
| IBC Conference: Bioprocess Control
Parameters |
| Maintaining quality and compliance with process
control |
| Dr. Chris Holloway (session
chairperson) |
| |
| European expectations for in-process control of
biotech production processes |
| Dr. Chris Holloway (speaker
) |
| |
| Process changes and comparability from the European
perspective |
| Dr. Dianne Jackson-Matthews (speaker) |
|
2001 21 February
Canberra, Australia |
| Presentation to the Therapeutic Goods
Administration, Australia |
| Comparability of medicinal products derived by
biotechnology processes – Relevance for variations |
| Dr. Chris Holloway (invited
speaker) |
|
2001 22-23
January
London, UK |
| IIR Symposium |
| Comparability of medicinal products derived by
biotechnology processes – Relevance for variations |
| Ms. Philippa Whiteside ( invited
speaker ) |
|
2000 28 November
Frankfurt, Germany |
| BPI Seminar |
| (sponsored by the BfArM and BPI) |
| Consistency criteria for biotechnologically-derived
medicinal products |
| Dr. Chris Holloway ( speaker
) |
|
2000 1-4
October
Washington, DC, USA |
| RAPS Annual Conference and Exhibition |
| Pre-conference workshop (organised by ERA Consulting
Group) Biotech Products: Getting it right in Europe |
Dr. Chris Holloway ( session
leader )
Dr. Russ Kaake ( speaker ) |
|
2000 20 September
Paris, France |
| World Vaccine Congress |
| Criteria for quality, consistency and comparability
of recombinant vaccines Part I – Quality/Consistency
Part II – Comparability |
| Dr. Chris Holloway (speaker) |
|
2000 10 May
Vienna, Austria |
| EuroRAPS 2000 |
| Consistency criteria for biotechnologically derived
medicinal products in Europe |
| Dr. Chris Holloway (panellist) |
|
1999 27-29
September
Geneva, Switzerland |
| World Vaccine Congress |
| Comparability and characterisation of vaccines
during process development and scale up |
| Dr. Chris Holloway (invited
speaker) |
|
1999 10-11
May
London, UK |
| IIR Symposium |
| Biotech generics – Regulatory realities and realistic
approaches |
| Dr. Chris Holloway (invited
speaker) |
|
1998 4 November
Frankfurt, Germany |
| BPI Seminar |
| Quality criteria for biotechnologically-derived
medicinal products |
| Dr. Chris Holloway (speaker)
|
|
1998 5-6
May
Strasbourg, France |
| EDQM - Viral Safety and Regulatory
Aspects - Animal Sera in the Manufacture of Pharmaceuticals |
| Viral safety requirements in Europe |
| Dr. Heike Volkmer (speaker ) |
|
1997 June
Houston, USA |
| BIO |
| Good science in protein characterization |
| Dr. John Gardner (speaker) |
|
