Conferences & Networking

Past Events

2013
16th - 18th April, 2013 World Vaccine Congress
Washington, DC

22nd - 25th April, 2013 BIO International Convention
Chicago, IL

2012
30th - 2nd November, 2012 AusBiotech National Conference
Melbourne, Australia

12th - 14th November, 2012 Bio-Europe Autumn
Hamburg, Germany

09th - 11th October, 2012 BioPartnering Europe
Brussels, CH

26th - 30th October, 2012 RAPS: The Regulatory Convergence
Seattle, USA

19th - 21st September, 2012 BIO Korea
Coex, Seoul, Korea

19th - 21st September, 2012 BioSpain 2012
Bilbao, Spain

27th - 28th September, 2012 ARCS 2012 Congress
Canberra, Australia

13th March - 17th March, 2012 Informa's Cell Line Development and Engineering
Cologne, Germany

19th March - 21st March, 2012 BIO Europe Spring 2012
Amsterdam, The Netherlands

24th March - 26th March, 2012 BioTrinity 2011
Newbury, UK

26th February - 28th February, 2012 BioPartnering North America
Vancouver, Canada

9th January - 11th January, 2012 Biotech ShowCase
San Francisco, CA, USA

23rd January - 25th January, 2012 WCBP Conference - CASSS
San Francisco, CA, USA

30th January - 1st February, 2012 Phacilitate Cell, Gene & Protein Therapeutics Forum
Washington DC

2011
1st December 2011 Genesis
London, UK

30th November - 1st December, 2011 Vaccines Europe 2011
Brussels, Belgium

31st October - 2nd November, 2011 Bio Europe
Duesseldorf, Germany

18th - 19th October, 2011 BioProduction
Berlin, Germany

17th - 19th October, 2011 AusBiotech 2011
Adelaide, Australia

10th - 11th October, 2011 BioPartnering Europe
London, UK

27th - 29th September, 2011 Bio Korea
Seoul, Korea

19th - 21st September, 2011 Phacilitate Cell & Gene Forum Asia
Singapore,

Update on the European Requirements for Advanced Therapy Medicinal Products - EU regulatory briefing (Sept 19)

Negotiating the latest TGA regulatory guidelines to capitalise on opportunities for early stage cell & gene therapy development in Australia (Sept 20)

8th - 9th September, 2011 BioPharma America 2011
Boston MA, USA

22nd - 23rd August, 2011 IBC Bioprocess International
Shanghai, China

Regulation of Pharmaceuticals in the USA

11th August, 2011 ARCS Training Course
Melbourne, Australia

Regulation of Pharmaceuticals in the USA

1st - 2nd August, 2011 CMC Strategy Forum
Bethesda MD, USA

Regulatory Strategies for Multiproduct Facilities

27th - 30th June, 2011 BIO
Washington DC, USA
18th - 19th May, 2011 European Biomarker Summit
London, UK
11th - 12th May, 2011 BioForum
Lodz, Poland
10th May, 2011 BioInnovation Workshop
South Australia
29th April, 2011 ARCS Training Course
New Zealand
18th April, 2011 DSM Biologics Roadshow
Brisbane, Australia
12th - 14th April, 2011 BioTrinity
Newbury, UK
11th - 13th April, 2011 DSM Biologics Roadshow
Perth, Adelaide and Melbourne, Australia
6th April, 2011 Medical Technology Association of Australia
Brisbane, Australia
5th April, 2011 BioProcess International (6th - 7th April 2011)
Nice, France

Pre-conference Workshop R: Comparability: Developing Strategies for Scaling Up and Other Process Changes
4th - 7th April, 2011 Characterization and Comparability for Biologics
Bethesda, MD

Comparability for Innovator Products from a European Perspective
28th March, 2011 ARCS Training Course
Sydney, Australia

Regulation of Pharmaceuticals in the USA course
14th - 16th March, 2011 Bio Europe Spring
Milan, Italy
9th - 10th March, 2011 Personalised Medicine and Diagnostics Europe
London, United Kingdom
2nd - 4th March, 2011 Vaccine Business Congress
Baltimore, MD, USA

Navigate a Crowded Marketplace to Make Your Vaccine Commercially Attractive (3rd March)
2nd - 3rd March, 2011 Life Science Innovation NorthWest
Seattle, WA, USA
27th February - 1st March, 2011 BioPartnering North America
Vancouver, Canada
14th - 18th February, 2011 Informa's Cell Line Development & Engineering 2011
Munich, Germany

European regulatory expectations surrounding cell lines used for the manufacture of recombinant proteins (16th February)
24th - 26th January, 2011 Phacilitate - Cell and Gene Therapy Forum
Washington, DC USA

Global regulatory update: Who's driving the sector forward and what are the corresponding R&D/commercial opportunities for the C&GT industry - Day 1

Workshop: Practical aspects of the regulation of gene and cell therapy products in the United States and the European Union: An in-depth regulatory workshop - Day 3
2010
9th December, 2010 Genesis
London, UK

Biomarkers
1st - 2nd December, 2010 Vaccines Europe
London, UK

Post conference Workshop: Practical Advice for Meeting Regulatory Requirements in Comparability Studies
27th November, 2010 IABS Workshop 2010
Singapore

Keynote lecture: Global regulatory landscape in evaluating biologicals, including biosimilars
15th - 17th November, 2010 Bio Europe
Munich, Germany
9th - 10th November, 2010 European Biomarkers Summit
Florence, Italy

Adding Value to Biomarker Development from the Regulatory Perspective (10th November)
25th - 27th October, 2010 3rd Pre-filled Syringes Conference
London, UK

Regulatory issues versus requirements for biological medicinal products in pre-filled syringes
19th - 22nd October, 2010 AusBiotech National Conference
Melbourne, Australia

Regulation of biotech products - keeping your cool in the EU

Integrating biomarkers into drug development: the importance of a suitable regulatory strategy
13th - 14th October, 2010 TRX Asia Pacific Biosimilar Symposium
Brisbane, Australia

Deficiencies during translational research leading to regulatory failures: case studies

Biologics: How far have we really come?
11th - 13th October, 2010 TRX
Brisbane, Australia

Qualifying cancer biomarkers for regulatory acceptance

Regulation of stem cell therapies in Australia

Translating Preclinical Findings into First-in-man Studies
30th September, 2010 ARCS Training Course
Sydney, Australia
21st - 22nd September, 2010 BIO India 2010
Hyderabad, India
15th - 17th September, 2010 BioPharm America 2010
Boston, USA
14th September, 2010 Audio Conference through FX Conferences

Development of a Manufacturing Process for a Vaccine; The Regulatory Implications
13th - 14th September, 2010 ARCS Congress 2010
Canberra, Australia

Pre-submission Meetings
1st - 3rd September, 2010 BIO Korea 2010
Seoul, Korea

The regulation of Advanced Therapies in Europe
13th July, 2010 AusBiotech Bioprocourse
Sydney, Australia

Audio Conference through FX Conferences

EU Regulatory and CMC/Quality Requirements for Advanced Therapy Medicinal Products
1st July, 2010 Quotient Bioresearach
Fordham, UK

Immunogenicity for Biopharmaceuticals Seminar

Case studies in regulatory failures related to immunogenicity
28th - 30th June, 2010 EuroBiotech Forum 2010
Paris, France
23rd June, 2010 EPIC Biotech 2010
London, UK
22nd - 24th June, 2010 China BIO 2010
Suzhou, China
21st - 23rd June, 2010 Phacilitate Vaccines/Immunotherapies
Barcelona, Spain

Workshop: EMEA regulatory update: Clarifying recent and novel guidelines and delivering the keys to successful and efficient navigation (23rd June: 1.40-2pm)
14th - 18th June, 2010 Recombinant Antibodies Informa 2010
Manchester, UK

Workshop: Biosimilar Antibodies - A Global Regulatory Perspective (17th June)
27th - 28th May, 2010 ARCS 2010 Congress
Sydney, Australia

Dilligence in Early-phase Biotech Development: Preclinical, Regulatory and Clinical strategies
19th May, 2010 PIPMG
Milton Keynes, UK

Navigating uncertainty - addressing ill-defined regulatory routes for novel biopharmaceuticals
12th - 14th May, 2010 6th Annual Monoclonal Antibodies Visiongain
London, UK

Biosimilar Antibodies - The regulatory perspective
11th - 12th May, 2010 2nd Annual Vaccine Conference Visiongain
London, UK

Downstream processing of cell culture based vaccines: A regulatory perspective (12th May)
4th - 6th May, 2010 Biomarker World Congress
Philadelphia, USA
3rd - 6th May, 2010 BIO 2010
Chicago, USA
21st April, 2010 AusBiotech Bioprocourse
Adelaide, Australia

Advancing from concept to clinic and beyond
20th April, 2010 AusBiotech Bioprocourse
Melbourne, Australia

Advancing from concept to clinic and beyond
19th - 20th April, 2010 World Vaccine Congress
Washington DC, USA

Panel Session: How can you align strategies with regulation to avoid barriers to vaccine development?

The feasability of a global regulatory strategy for vaccines
12th - 14th April, 2010 IBC's Biomanufacturing and single-use Systems Summit
Korea

Comparability: Developing Strategies for Scaling up and other process changes
25th March, 2010 ARCS Training Course
New Zealand

Regulation of Pharmaceuticals in the USA
23rd - 24th March, 2010 Biomarkers Triconference
London, UK

Integrating your Biomarker into Drug Development: The Importance of the EMEA/FDA Qualification Procedures
22th - 24th March, 2010 NZ Bio 2010
Auckland, New Zealand

Cell Therapy Product Development. A Regulatory Perspective

Early Phase Clinical Trials: Opportunities for Australasian Biotech Companies from the Regulatory Perspective
8th - 10th March, 2010 BioEurope Spring 2010
Barcelona, Spain
25th - 26th February, 2010 5th Annual Biomarkers Congress
Manchester, UK

Opportunities in the regulatory framework to support biomarker development: Comparing and contrasting Europe and the USA
23rd - 25th February, 2010 9th Annual Bio Windhover 2010
New York, USA
23rd - 24th February, 2010 Informa Life Sciences: 11th Annual Phase I Clinical Trials
London, UK

Advanced Therapy Phase I Trials
23rd February, 2010 ARCS Traning Course
Sydney, Australia

Regulation of Pharmaceuticals in the USA
4th - 5th February, 2010 KoNECT and Asian Medical Center Symposium
Korea

Regulatory updates in the USA
1st - 2nd February, 2010 Biosquare 2010
Genava, Switzerland
24th - 26th January, 2010 Phacilitate: Cell & Gene Therapy Forum 2010
Washington D.C., USA

Workshop: Regulatory Surgeries
24th - 26th January, 2010 BioPartnering North America
Vancouver, Canada
21st January, 2010 Audio conference through FX Conferences

Topic: Opportunities in the regulatory framework to support biomarker development: Comparing and contrasting Europe and the USA
2009
10th - 11th December, 2009 Genesis
London, UK
7th - 8th December, 2009 Visiongain Vaccine Research & Development
London, UK

Current regulatory concerns regarding long-term safety of vaccines
17th - 18th November, 2009 Informa Life Sciences: Vaccines Europe
Brussels, Belgium

A Practical Approach to Comparability Studies for Vaccines.
9th - 11th November, 2009 Phacilitate Oncology Leaders Forum
Boston, USA

Avoiding regulatory pitfalls associated with novel platforms in oncology.
Given the economic, healthcare and R&D trends, issues and advances discussed over the previous 2 days, what should the full R&D process, from basic research through to pivotal trials, licensure and reimbursement, look like for a cancer stem cell therapeutic entering the pipeline in the near future?
5th - 6th November, 2009 European Biomarkers Summit
Barcelona, Spain

Biomarker Qualification: Europe is ready, are you?
5th November, 2009 SFDA Biosimilars workshop
Beijing, China

Importance of Molecular Similarity - Ensuring the quality and comparability of biosimilar products
2nd - 4th November, 2009 BIO-Europe 2009
Vienna, Austria
27th - 30th October, 2009 AusBiotech
Melbourne, Australia

Product Development and Regulatory Aspects in Asia-Pacific.
26th - 28th October, 2009 Informa Life Sciences: BioProduction 2009
Barcelona, Spain

Comparability: Developing strategies for scaling up and other process changes
22nd October, 2009 QCTN: Stem Cell Symposium
Brisbane, Australia

Implementation of the European Regulation for Advanced Therapy Medicinal Products and its Consequences for Stem Cell Products.
22nd October, 2009 Medical BioDefense Conference
Munich, Germany

Regulatory Approaches to Biodefence Products in Europe and USA - Compare and Contrast
12th - 14th October, 2009 FIGON Dutch Medicines Days:
Developing Groundbreaking New Treatments for Gene and Cell Therapy and Tissue Engineering

Lunteren, The Netherlands

What are Advanced Therapy Medicinal Products and why do they require special scientific and regulatory attention?

The new European regulatory framework for Advanced Therapy Medicinal Products.
11th - 14th October, 2009 BioPartnering Europe and BioPartnering China
London, UK
5th - 8th October, 2009 World Vaccines Congress
Lyon, France

Vaccine Regulatory Framework Day.
23rd - 25th September, 2009 EuroBiO
Lille, France

Regulatory Workshop:
"Opportunities and Challenges for Biosimiliars in the Global Market".
16th - 18th September, 2009 BioPharma America 2009 San Francisco, USA
16th - 18th September, 2009 BIO Korea 2009
Seoul, Korea

Early Phase Product Development: Helping Korean Companies to Access Western Market.
15th September, 2009 intERActions logo
San Francisco, USA

Including Europe in your strategy to add value to early stage biotech product development.
14th September, 2009 intERActions logo
San Francisco, USA

The regulation of 'Advanced Therapy Medicinal Products' (cell therapy, gene therapy and tissue engineered products) in Europe, from the clinic to approval.
17th - 20th August, 2009 International Seminar on Biotechnology
Current status of biopharmaceuticals in Colombia and the World
Bogota, Columbia

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*).
29th June - 1st July, 2009 Euro-Biotech Forum
Barcelona, Spain
25th June, 2009 EPIC
London, UK
22nd - 24th June, 2009 Phacilitate Active Immunotherapeutics/Vaccine Forum
Barcelona, Spain

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?
Workshop: Influenza vaccines: Is industry supplying what government and public health demand?

Plenary Session: Bringing novel adjuvants to market: Gaining clarity on regulatory pathways and clinical data requirements upon which to build the business model.
21st - 25th June, 2009 DIA 2009
San Diego, USA

Adding value to early stage biotech product development
15th - 19th June, 2009 Informa Recombinant Antibodies 2009
Cologne, Germany

European regulatory expectations applicable to early development of recombinant antibodies: The legacy of Tegenero (TGN 1412) 3 years on
18th June, 2009 Regenerative Medicine: A Forum For Clinical Need
London, UK
15th - 17th June, 2009 ILSI-BIOMED
Tel Aviv, Israel
14th - 16th June, 2009 CALAsia
San Diego, USA

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?
12th June, 2009 AusBiotech Professional Development Workshop 2009
Sydney, Australia

Advancing from concept to clinic and beyond: Understand and engage USA and European regulators and achieve your approvals faster.
10th June, 2009 AusBiotech Professional Development Workshop 2009
Melbourne, Australia

Advancing from concept to clinic and beyond: Understand and engage US and European regulators and achieve your approvals faster.
9th June, 2009 AusBiotech Professional Development Workshop 2009
Brisbane, Australia

Advancing from concept to clinic and beyond: Understand and engage US and European regulators and achieve your approvals faster.
18th - 21st May, 2009 BIO2009
Atlanta, USA
3rd - 6th May, 2009 ISCT's 15th Annual Meeting
San Diego, USA

Preparation and maintenance of quality and manufacturing regulatory submissions (CMC)
13th - 15th April, 2009 BioWindhover 2009
New York, USA
8th April, 2009 Hopkins Biotech Network, John Hopkins University
Rockville, USA

Similar Biological Medicinal Products and their regulation: Europe versus the US
18th March, 2009 London Biotech Network: BioWednesday
London, UK

Early phase clinical trials: Opportunities for UK biotech companies from the regulatory perspective
16th - 18th March, 2009 BioEurope Spring 2009
Milan, Italy
9th - 11th March, 2009 BioSquare 2009 and BioVision Life Sciences Forum
Lyon, France
9th - 11th March, 2009 NZBio 2009
Auckland, New Zealand

Biotech product in early development? Manage regulatory risks!
2nd - 6th March, 2009 Informa Cell Line Development and Engineering
Berlin, Germany

Regulatory considerations in cell line development
8th - 10th February, 2009 Biopartnering North America
Vancouver, Canada
26th - 29th January, 2009 Phacilitate Vaccine/Cell & Gene Therapy Forum 2009
Washington D.C., USA

Deciding when to take the national and when to take the centralized route in Europe: Reaping the benefits of making the right strategic choice

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
2008
9th - 10th December, 2008 Genesis 2008
London, UK

Adding value to biotech product development from the regulatory perspective
2nd - 3rd December, 2008 Informa Vaccine Scale-up and Manufacturing
Brussels, Belgium

Scale-up in manufacturing and the development of a commercial process:
The regulatory implications
26th - 29th October, 2008 AusBiotech 2008
Melbourne, Australia

Investing in Cell Therapies in Australia - From Benchtop to Patient
20th - 22nd October, 2008 IBC's BioProcess International, Asia Pacific
Mumbai, India

Pre-conference Summit: "Developing Your Biosimilar Strategy for the International Market"

Biosimilar Medicines, Science and Regulation for Development and Approval
14th - 15th October, 2008 Informa Biological Assays

Bioassay development from the regulatory perspective
9th October, 2008 World Courier Global Clinical Trial Management and Logistics
Tokyo, Japan

Biotechnology companies and the FDA - getting your trials up and running in the US
7th - 9th October, 2008 EuroBiO 2008
Paris, France

Agency Interactions in Europe: Best Practice
6th - 8th October, 2008 TOPRA 5th Annual Symposium 2008
Budapest, Hungary

Regulating Novel Technologies
22nd - 24th September, 2008 ISCT 8th Annual Somatic Cell Therapy Symposium
Bethesda, USA

Challenges of international studies from the regulatory and business perspectives:
A regulatory overview highlighting the regulatory frameworks in the US, Europe and Asia
7th - 9th August, 2008 Clinical Research Excellence 2008
Brisbane, Australia

Research, Education & Ethics

Strategy & Regulations: Preparing for Clinical Trials
22nd - 26th June, 2008 DIA 2008
Boston, USA

Comparability of Biopharmaceuticals
17th - 21st June, 2008 BIO 2008
San Diego, USA

QTCN Session: Regulatory challenges and solutions in Asia-Pacific
21st - 24th April, 2008 Informa BPI 2008
Vienna, Austria

Regulatory comparability safety strategy for biosimilars and for change implementation
7th - 10th April, 2008 6th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology
Barcelona, Spain

The regulatory landscape for similar biological medicinal products in the EU and US: comparisons, contrasts and challenges
28th - 30th January, 2008 Phacilitate Vaccine/C&G Forum 2008
Washington D.C., USA

What are the key trends in the ongoing evolution of the global regulatory environment for cell and gene therapies?

Impact and consequences of the evolving regulatory framework for cell and gene therapy products from the industry perspective
2007
29th November - 1st December, 2007 ABTRF
Margaret River, Australia

Update on the Regulation of Advanced Therapies in Europe
13th - 14th November, 2007 Informa's Stability Testing for Biologics
Prague, Czech Republic

EU Regulation of Medicinal Products: Product Stability Issues and Post-approval Commitments
5th - 7th November, 2007 European Antibody 2007
Lyon, France

Nonclinical safety Assessment for Antibodies
29th - 30th October, 2007 intERActions logo
Melbourne, Australia

The Regulatory Procedures for Pharmaceuticals in the United States and Europe: Introductory Course with Special Emphasis on Biopharmaceuticals
21st - 24th October, 2007 AusBiotech 2007
Brisbane, Australia

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"
10th - 11th October, 2007 IBC's Early Development Of Therapeutics
Hamburg, Germany

Adding value to the development of biotechnology-derived medicinal products from the European regulatory perspective
30th September - 4th October, 2007 BPI 2007
Boston, USA

Overcoming the Regulatory Challenges in Development of Biosimilar Medicines<
25th - 28th September, 2007 EuroBio 2007
Lille, France

Adding value to the development of biotechnology-derived medicinal products from the European regulatory perspective
24th - 26th September, 2007 BioPharm Asia 2007
Singapore

Pre-conference Masterclasses: "Overcoming the Regulatory Challenges in Development of Biosimilar Medicines"
Conference 2: Biosimilars: Taking Follow-on Biologics to Market
19th - 20th September, 2007 SMi's Biologics Conference
London, UK

Adding Value to Biotech Product Development from the EU Regulatory Perspective
11th - 13th September, 2007 Terrapin's BioPharm Scale-up
Geneva, Switzerland

Demonstrating Comparability Following Scale-up: A Focus on Therapeutic Antibody Products
18th - 20th July, 2007 intERActions logo
Washington D.C., USA

The Basics of Regulatory Affairs in the Context of Product Development with Special Emphasis on Biopharmaceuticals and Advanced Therapy Medicinal Products
17th - 21st June, 2007 DIA 2007
Atlanta, USA

Legal and regulatory status of similar/comparable biological medicinal products in Europe and the United States: Key similarities/differences
Pitfall of process changes during biotech product development from the CMC perspective
4th - 6th June, 2007 ARCS 2007 Annual Scientific Congress
Sydney, Australia

Demystifying the European and US Regulatory Markets
Regulation of Biopharmaceuticals in Australia
31st May - 1st June, 2007 Phacilitate Vaccine Forum 2007
Munich, Germany

Regulatory perspective: Clarifying approaches to Marketing Authorisation in the EU of vaccines derived from novel manufacturing technologies
24th - 26th April, 2007 BioProcess International 2007
Paris, France

Recent developments relating to the regulation of 'comparable biological products' in the United States
Workshop on 'Managing Biopharmaceutical CMC Changes from the Regulatory Perspective'
16th - 18th April, 2007 Life Science World Alliance 2007
London, UK

Adding value to biotech product development from the European regulatory perspective
26th - 28th March, 2007 DIA Euromeeting 2007
Vienna, Austria

Regulatory workshop: Comparability of BioPharmaceuticals
22nd March, 2007 BioMelbourne Workshop
Melbourne, Australia

Understanding Regulatory Afairs in the Austrlian, US and European Markets
8th - 9th March, 2007 CMC Strategy Forum Europe 2007
Brussels, Belgium

Action Limits and their application in the context of Process Specifications
22nd - 24th January, 2007 Phacilitate Cell & Gene Therapy Forum 2007
Baltimore, USA

Opportunities within the new European regulatory framework for Advanced Therapy Products
Regulatory workshop: Navigating the European regulatory mechanisms for Advanced Therapy Products
2006
4th - 6th December, 2006 European Antibody congress
Lyon, France

CMC Challenges During Clinical Development of Human Antibodies
23rd - 24th November, 2006 Generics - Asia
Singapore

Biosimilar Medicines: A Trivial Pursuit, or more?
7th - 8th November, 2006 IBC's Post-Translational Modifications
Basel, Switzerland

Regulatory Perspective on Post-Translational Modifications
23rd - 25th October, 2006 Australian Clinical Research
Brisbane, Australia

Australian Clinical Research and the FDA
20th October, 2006 World Courier Conference
Melbourne, Australia

Biotech and the FDA: Getting Clinical Trials Going in the US
9th - 11th October, 2006 World Vaccine Congress 2006
Lyon, France

Regulatory and Product Development Issues Associated with DNA Vaccines: Development to Marketing Approval
3rd - 5th October, 2006 Cancer Vaccine Development 2006
London, UK

Pre-conference Workshop: Regulatory Considerations in the Development of Cancer Vaccines
28th September, 2006 Seminar at the London Bioscience Innovation Centre
London, UK

Adding Value to Early Stage Biotech Product Development from the Regulatory Perspective
13th - 14th September, 2006 PABORD 2006
London, UK

New opportunities for small biotech enterprises from the regulatory perspective
30th June, 2006 IBC�s Congress on Recombinant Antibodies Forum 2006
Zurich, Switzerland

Regulations in the Global Antibody Market
29th - 30th June, 2006 IBC�s Follow On Biologics
Zurich, Switzerland

General Regulatory and Legal Environment
27th - 28th June, 2006 IBC�s Comparability for Biologics
Zurich, Switzerland

Impact of scale-up, post-translational modification, and process change on product characteristics and on safety, efficacy and stability
19th - 22nd June, 2006 bioLOGIC Europe 2006
Amsterdam, The Netherlands

Manufacturing issues: Practicability
Adding value to early stage clinical development of biologics within the framework of the Directive
18th - 22nd June, 2006 DIA 2006
Philadelphia, USA

Understanding the Regulation of Advanced Therapy Medicinal Products in Europe
Practical Application of Scientific Advice in the Development of Biologics
Requesting and Obtaining Scientific Advice in the European Union from Member State Agencies
5th - 7th June, 2006 ARCS 2006 Annual Scientific Congress
Sydney, Australia

Regulatory Intelligence
16th - 17th May, 2006 DIA - European Regulatory CMC workshop
Vienna, Austria

European Regulatory CMC - An Overview
4th - 7th May, 2006 ISCT 2006
Berlin, Germany

Regulatory Strategies for Early-Stage Development of Cell Therapy Products
26th - 27th April, 2006 PDA 2006 Process Validation
Anaheim, USA

European viewpoint on process validation comparability
5th - 7th April, 2006 IBC Biopharmaceutical Spring School
Cambridge, UK

Preclinical and Clinical Development
24th March, 2006 DIEVINI Spring meeting
Heidelberg, Germany

Adding Value to Early-Stage Biotech Product Development from the European Regulatory Perspective
20th - 23rd March, 2006 World Vaccine Congress 2006
Washington D.C., USA

Regulatory pitfalls in early stage development of therapeutic vaccines
6th - 8th March, 2006 EuroDIA 2006
Paris, France

Workshop on "Similar Biological Medicinal Products"
Comparability - Evaluating and Making Manufacturing Changes for Biotech Products.
23rd February, 2006 ECPM Workshop
Basel, Switzerland

Workshop on " The Latest on Biologicals and Biosimilars"
30th January - 1st February, 2006 Phacilitate Vaccine / Cell and Gene Therapy Forum
Baltimore, USA

Addressing the latest regulatory challenges for cell and gene therapies in North America and Europe.
Update on the European regulation of cell therapy and gene therapy medicinal products
2005
8th - 9th December, 2005 Plenary ACTIP Meeting
Goettingen, Germany

The Global View of Similar Biological Medicinal Products - Scientific and Legal Issues
24th - 26th November, 2005 Second Australian Biotherapeutics and Tissue Regeneration
Margaret River, Australia

Regulatory Renovations in the US and Europe: Making space for cell/gene/tissue therapies
21st - 23rd November, 2005 AusBiotech 2005 Annual Conference and Exhibition
Perth, Australia

Regulatory Harmonisation in Europe - opportunities and challenges for the biotech industry
16th November, 2005 intERActions logo
Brisbane, Australia

EU Regulatory Update
15th November, 2005 intERActions logo
Sydney, Australia

EU Regulatory Update
14th November, 2005 intERActions logo
Melbourne, Australia

EU Regulatory Update
24th - 27th October, 2005 BioProduction 2005
Amsterdam, The Netherlands

Validating the clearance of product- and process-related impurities
17th - 19th October, 2005 RAPS 2005
Baltimore, USA

Seeking Scientific Advice: Experiences in the US And Europe
Comparability exercises for biologics in pre- and post-approval scenarios from the European perspective
14th - 15th September, 2005 PABORD 2005
London, UK

Adding Value to Early Stage Biotech Product Development from the Regulatory Perspective
8th September, 2005 PFC Regulatory Forum on Biosimilar Medicinal Products
Zurich, Switzerland

Case studies in comparability of biological medicinal products: Consequences for products claimed to be similar to another one already marketed
18th - 19th July, 2005 IIR CMC EU Clinical Trials CTD Conference
New York City, USA

Overcoming CTD Content Conversion Challenges
The EU Clinical Trials Directive- the New CMC Submission Requirements
26th - 30th June, 2005 DIA 2005
Washington D.C., USA

Case studies in comparability of biological medicinal products: Consequences for products claimed to be similar to another one already marketed
1st - 3rd June, 2005 IIR Follow-on Biologics
London, UK

Challenges in comparability: from innovator to follow-on biologic
24th - 25th May, 2005 IIR Scientific Advice 2005
London, UK

Preparations for Scientific Advice
23rd - 26th May, 2005 bioLOGIC 2005
Geneva, Switzerland

Adding value to early stage clinical development of biologics within the framework of the Directive
19th May, 2005 BIA BioBusiness Exchange 2005
London, UK

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
1st - 2nd March, 2005 IBC Follow-on Biologics Conference
Brussels, Belgium

Follow-on biologics: an unrecognised minefield
Risk-analysis of follow-on biologic: factors to consider
24th - 26th January, 2005 Phacilitate Gene Forum
Washington D.C., USA

Cell therapy and tissue engineering regulation in North America and Europe
Cell and tissue therapy product development and manufacture
2004
6th - 7th December, 2004 IBC Global Follow-On Biologics Conference
Reston, VA, USA

Issues in the Globalization of Follow-On Biologics
17th - 19th November, 2004 bioLOGIC Asia 2004
Singapore

Current Regulatory Approaches to Biogeneric Products in the US and Europe and Consequences from Products Developed in Asia
The Current Status of European Regulations and Directives Relating to Biologics
16th November, 2004 intERActions logo
ARCS/AusBiotech Co-sponsored Seminar
Melbourne, Australia

The current status of European regulations and directives relating to biotech/biologics
15th November, 2004 intERActions logo
ARCS/AusBiotech Co-sponsored Seminar
Sydney, Australia

The current status of European regulations and directives relating to biotech/biologics
7th - 10th November, 2004 AusBiotech 2004 Annual Conference and Exhibition
Brisbane, Australia

Rational Approaches to the Preclinical Phase of Biotech Product Development
Secrets of a Successful IND Meeting: What Can Go Wrong in a pre-IND/IND Process
2nd - 5th November, 2004 Phacilitate Fall Conference
Cambridge, MA, USA

Preparing Your Organisation for Clinical Development on a Global Scale
27th - 28th October, 2004 IIR Conference "Comparability Testing"
London, UK

An Overview of the Current FDA Guidelines for Biocomparability Issues - a US Perspective
10th - 13th October, 2004 RAPS 2004 Annual Conference and Exhibition
The Changed Regulatory Environment for Biologics in the EU
14th - 15th September, 2004 FDA Public Workshop: Scientific Considerations Related to Developing Follow-on Protein Products
Rockville, MD, USA

Comparability Exercises: Limitations for Follow-on Biologics (FBOs) - The European Perspective
8th - 10th September, 2004 Barnett Biopharmaceutical Comparability Conference
Philadelphia, PA, USA

Comparability in the European Union: Regulatory and Scientific Approaches
Developments in the European Union on Biosimilar Medicinal Products: Defining the Genre
22nd - 24th June, 2004 bioLOGIC Conference 2004
Geneva, Switzerland

Meeting the Regulatory Challenge of Releasing Clinical Trial Material into Europe in Light of the New EU Clinical Trials Directive.
8th - 9th June, 2004 IBC Conference "Comparability and Immunogenicity of Biologicals"
Berlin, Germany

Regulatory Viewpoint in the US on Comparability and Immunogenicity
10th - 13th May, 2004 Phacilitate Spring Vaccine Forum
Amsterdam, The Netherlands

Chair person's intro: Vaccines within the Context of Biological Medicinal Products: Regulatory Developments in the European Union
Workshop: Understanding and Complying with the EU Clinical Trial
Directive: A Practical Guide for Vaccine Companies
15th - 17th March, 2004 IBC Conference "Manufacturing Off-Patent Biologics"
La Jolla, CA, USA

Off-Patent Biologics Product Comparability: How Similar Is Similar Enough?
Keynote address: The European View on Similar Biological Products: Scientific and Regulatory Considerations
Panel Discussion: Divining a Regulatory Framework
for Off-Patent Biologics
9th - 12th March, 2004 DIA EuroMeeting 2004
Prague, Czech Republic

CMC Challenges in Early Preclinical and Clinical Development
26th - 27th February, 2004 IIR Seminar "EU Clinical Trials Directive"
Philadelphia, PA, USA

Determining the Implications of the EU Clinical Trials Directive for Biotech and Biological Product Development and Research
23rd - 24th February, 2004 IBC Conference "Process Validation for Biologicals"
San Diego, CA, USA

Europe: Review of the European Approach to Comparability
2003
2nd - 4th December, 2003 CORDIA EuropaBio Convention 2003
Vienna, Austria

Interacting with Regulators in Europe & the United States - Comparing the "Scientific Advice" Systems for Biotech Products
10th - 12th November, 2003 IIR International Clinical Trials Conference
Washington, DC, USA

Introduction to the EU Clinical Trials Directive and how it Impacts Clinical Trials Processes workshop
22nd - 23rd October, 2003 Strategic Research Institute
Generic Biopharmaceuticals conference
Reston, VA, USA

Biogenerics in Europe: The Ultimate Fata Morgana
Biogeneric Products in Europe: Resolving the Mirage?
19th - 22nd October, 2003 RAPS 2003 Annual Conference and Exhibition
Baltimore, MD, USA

Session: Understanding the Clinical Trials Directive
Session: Challenges in Medicinal Product Approval in Europe: Case Studies for Biotech Products
30th September - 1st October, 2003 IIR Conference "Immunogenicity of Protein-based Therapeutics"
Amsterdam, The Netherlands

Regulatory considerations - US viewpoint
29th - 30th September, 2003 World Vaccine Congress 2003
Lyon, France

Easing the Regulatory Process
Strategies for Implementing Compliant Solutions for CTD and eCTD Submissions
1st September, 2003 intERActions logo
ARCS sponsored seminar
Sydney, Australia

Update and Trends in the Regulation of Biopharmaceutical Products in Europe
22nd August, 2003 intERActions logo
AusBiotech/ARCS sponsored seminar
Brisbane, Australia

Adding Value to Early Stage Biotech Product Development
Overview of Importance of Early Stage Planning - Issues in CMC Development
Issues in pre-Clinical Development
Issues Relating to Clinical Development
Case Studies and Summary
21st August, 2003 intERActions logo
AusBiotech/ARCS sponsored seminar
Brisbane, Australia

Cell therapy products - concepts for their development and regulation
Advanced Cell and Tissue Therapy Products in Europe and the USA: Legislation and Oversight
Advanced Cell and Tissue Therapy Products in Europe and the USA: Regulatory Procedures
Product Development Issues Relating to Quality and Safety
Case Studies in Cell and Tissue Product Development
20th August, 2003 intERActions logo
AusBiotech/ARCS sponsored seminar
Melbourne, Australia

Cell therapy products - concepts for their development and regulation
Advanced Cell and Tissue Therapy Products in Europe and the USA: Legislation and Oversight
Advanced Cell and Tissue Therapy Products in Europe and the USA: Regulatory Procedures
Product Development Issues Relating to Quality and Safety
Case Studies in Cell and Tissue Product Development
16th - 19th August, 2003 AusBiotech 2003 Annual Conference and Exhibition
Adelaide, Australia

Developing Successful Manufacturing Strategies for Biopharmaceutical Products
Case Studies in Outsourcing - A Critical View of Experience in the USA and Europe 4th - 6th June, 2003
bioLOGIC Conference 2003
Geneva, Switzerland

Achieving Regulatory Compliance
Enhancing the Development of Cutting Edge Biological Products Using Regulatory Intelligence
19th - 22nd May, 2003 Phacilitate Spring Vaccine Forum
Amsterdam, The Netherlands

Pre-conference workshop: Adapting the CTD for a Vaccine
8th - 9th May, 2003 IBC Well Characterized Biologicals conference
Bethesda, MD, USA

The European Perspective on Comparability for Biologics
The Role of Comparability Studies in Risk Assessment of Biological Products
29th - 30th April, 2003 IPQC Preparing for Compliance with the EU Clinical Trials Directive
London, UK

Analysing and Interpreting the Provisions in the Directive Relating to Biotechnology Product Development and Research
20th - 21st March, 2003 RAPS Discussion Forum
London, UK

Development and Regulation of Cell-Based Therapies
5th - 7th March, 2003 DIA EuroMeeting 2003
Rome, Italy

Concepts and Limitations of Comparability for post-Patent Biopharmaceutical Products
25th - 26th February, 2003 IBC EU Clinical Trials Directive Conference
London, UK

Implementation workshop: Audience participation - Exchanging Directive Problems that have been Encountered
2002
11th - 12th December, 2002 intERActions logo
IBC Professional Development Course
Washington D.C., USA

Understanding the European Regulation of Biological Medicinal Products
9th December, 2002 IBC Multi-Source Biologics Conference
Bethesda, MD, USA

Interactive pre-conference symposium (half day)
Characterization: When can it be used to demonstrate comparability? Pros and Cons
Comparability and multisource biotech products from the European perspective
Characterization and Comparability - panel discussion
6th - 9th October, 2002 RAPS Annual Conference and Exhibition
Washington D.C., USA

Pre-conference workshop:
Transatlantic Biotech Products: The challenges in creating the quality section of the CTD
30th September - 2nd October, 2002 World Vaccine Congress
Lyon, France

US and European regulation harmonisation: Avoiding the production bottlenecks
Panel Session: Global vaccine regulation - the future for vaccine regulation and co-operation
23rd August, 2002 AusBiotech 2002
Sydney, Australia

Regulatory Affairs Symposium

Current international regulatory expectations for the development of biotechnology-derived pharmaceutical products
Overview of Regulatory Procedures for medicinal products in the European Union - The present and the future
Overview of regulatory procedures for medicinal products in the USA: Biotech and beyond
Points to Consider in early-stage development of biotech and biological products
Issues of Comparability during early stage development of biologic/biotech products: Regulatory consequences
Adding Value to early-stage biotech drug development with regard to regulatory considerations
Regulatory Approaches to clinical trials in the USA and Europe:
Impact of the new European clinical trials Directive
22nd August, 2002 AusBiotech 2002
Melbourne, Australia

Regulatory Affairs Symposium

Current international regulatory expectations for the development of biotechnology-derived pharmaceutical products
Overview of Regulatory Procedures for medicinal products in the European Union - The present and the future
Overview of regulatory procedures for medicinal products in the USA: Biotech and beyond
Points to Consider in early-stage development of biotech and biological products
Issues of Comparability during early stage development of biologic/biotech products: Regulatory consequences
Adding Value to early-stage biotech drug development with regard to regulatory considerations
Regulatory Approaches to clinical trials in the USA and Europe:
Impact of the new European clinical trials Directive
5th - 7th June, 2002 bioLOGIC Conference 2002
Geneva, Switzerland

Biotech manufacturing - convergence of biotech and pharma? Panel Discussion
Advanced therapy medicinal products: New regulatory perspectives in Europe
13th - 16th May, 2002 Phacilitate Spring Vaccine Forum
Paris, France

Roundtable Discussion: "Key regulatory challenges involved in variations and clinical trials and identifying potential solutions"
Regulatory Aspects of cancer vaccines
7th - 10th May, 2002 EuroRAPS 2002
Budapest, Hungary

Compiling the Quality sections of a Common Technical Document for a biotech or biological product
Update on regulatory expectations for TSE matters
European regulatory framework
Compiling the quality sections of a Common Technical Document for a biotech or biological product
Future of biomedicine and regulation - Plenary session
6th - 8th May, 2002 IBC TIDES 2002
Las Vegas, USA

European regulatory expectations
Co-moderation of Focus group
5th - 8th March, 2002 EuroDIA 2002
Basel, Switzerland

Biogenerics and comparability - Panel discussion
13th - 18th January, 2002 AAPS: Annual Pharmaceutical Technology Conference
Harriman, NY, USA

European regulatory aspects of biological product dosage forms
15th - 16th January, 2002 RAPS Global Awareness Conference
Alexandria, VA, USA

Recent developments in biologics/biotechnology regulations
Regional harmonisation of standards for drugs and biologics in Europe
TSE regulations
How to fulfil TSE regulations
2001
6th - 7th December, 2001 IBC Oligonucleotide and Peptide Conference
Hamburg, Germany

How to get your biotech product approved in Europe
5th - 7th November, 2001 RAPS Annual Conference and Exhibition
Baltimore, MD, USA

Recent CMC developments
CMC developments as a result of ICH
Issues of comparability from the European perspective
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
18th - 19th October, 2001 IBC Conference: Bioprocess Control Parameters
Bethesda, MD, USA

Maintaining quality and compliance with process control
European expectations for in-process control of biotech production processes
Process changes and comparability from the European perspective
21st February, 2001 Presentation to the Therapeutic Goods Administration, Australia
Comparability of medicinal products derived by biotechnology processes - Relevance for variations
22nd - 23rd January, 2001 IIR Symposium
London, UK

Comparability of medicinal products derived by biotechnology processes - Relevance for variations
2000
28th November, 2000 BPI Seminar (sponsored by the BfArM and BPI)
Frankfurt, Germany

Consistency criteria for biotechnologically-derived medicinal products
1st - 4th October, 2000 RAPS Annual Conference and Exhibition
Washington D.C., USA

Pre-conference workshop (organised by ERA Consulting Group) Biotech Products: Getting it right in Europe
20th September, 2000 World Vaccine Congress
Paris, France

Criteria for quality, consistency and comparability of recombinant vaccines Part I - Quality/Consistency Part II - Comparability
10th May, 2000 EuroRAPS 2000
Vienna, Austria

Consistency criteria for biotechnologically derived medicinal products in Europe
1999
27th - 29th September, 1999 World Vaccine Congress
Geneva, Switzerland

Comparability and characterisation of vaccines during process development and scale up
10th - 11th May, 1999 IIR Symposium
London, UK

Biotech generics - Regulatory realities and realistic approaches
1998
4th November, 1998 BPI Seminar
Frankfurt, Germany

Quality criteria for biotechnologically-derived medicinal products
5th - 6th May, 1998 EDQM - Viral Safety and Regulatory Aspects - Animal Sera in the Manufacture of Pharmaceuticals
Strasbourg, France

Viral safety requirements in Europe
1997
June, 1997 BIO
Houston, USA

Good science in protein characterization