Conferences & Networking
Past Events
| 2012 | ||
|---|---|---|
| 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> 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 |
 San Francisco, USA Including Europe in your strategy to add value to early stage biotech product development. |
|
| 14th September, 2009 |
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 | 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 | 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 | Brisbane, Australia EU Regulatory Update |
|
| 15th November, 2005 | Sydney, Australia EU Regulatory Update |
|
| 14th November, 2005 | 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 | ARCS/AusBiotech Co-sponsored Seminar Melbourne, Australia The current status of European regulations and directives relating to biotech/biologics |
|
| 15th November, 2004 | 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 | ARCS sponsored seminar Sydney, Australia Update and Trends in the Regulation of Biopharmaceutical Products in Europe |
|
| 22nd August, 2003 | 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 | 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 | 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 | 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 |
|