pharmabio consulting

PharmaBio’s Lectures

PharmaBio Conference lectures and trainings (recent and current) 2012/2013/2014/2015/2016:

Dr. Hoss A Dowlat, Strategic insights into European (CHMP/EMA) and American (FDA) regulatory aspects of stability, Establishing Accurate and Efficient Stability Design Stability Testing & Higher Order Structure of Biologics, Informa Life Sciences, 26th -27th September 2012, Berlin.

Dr. Hoss A Dowlat, Leveraging Emerging Markets Approvals into a global regulatory strategy extending to the EU, USA and Japan: SME case study, Global Regulatory Strategy, Informa Life Sciences, 27-28 November 2012 , Danubis Hotel | London.

Dr. Hoss A Dowlat, Comparing and contrasting Regulatory Pathways (WHO, FDA, EMA ), 2nd Middle East conference on Biosimilars, Jordanian Association of Pharmaceutical Manufacturers (JAPM), 2012, 13/14 November, Amman- Jordan.

Dr. Hoss A Dowlat, Risk assessment: approaches to ensure dose accuracy within a EU/US regulatory compliance framework, Pre-Filled Syringes & Injector Devices for Biologicals, Informa Life Sciences, 5-6 December 2012 , Radisson Blu Hotel Berlin.

Dr. Hoss A Dowlat, Evaluating the pathway for registration of Biosimilars in USA to gain swift product approvals, Global Pharma Regulatory Summit, Mumbai, India, 12 March 2013.
Dr. Hoss A Dowlat, Highlights of 2013 registration status of biosimilars in the EU, Global Pharma Regulatory Summit, Mumbai, India, 13 March 2013.

Dr. Hoss A Dowlat, Risk management of biosimilar products: Challenges compared to development of originator biologics or small molecules, PTI Informa, In-house Pharma Training Course Istanbul, 25-26 March 2013.

Dr. Hoss A Dowlat, Expectation and opportunities of Bringing Biosimilars from China to EU, from Regulatory Point of View, 14 May 2013, 5th DIA China Annual Meeting (May 12-15), Beijing, China, May 13, 2013.

Dr. Hoss A Dowlat, Cell Therapy and Biosimilar Development, Opportunities, and Regulatory Considerations, 5th DIA China Annual Meeting (May 12-15), Beijing, China, , May 13, 2013.
Dr. Hoss A Dowlat, Exploring latest FDA/EMA concepts of US-EU comparability criteria based on biosimilars experiences, and potential impact on the life cycle of new biologics, International Broadcast, FDANEWS, 9 May 2013.

Dr. Hoss A Dowlat, Comparing and contrasting strategic regulatory/clinical perceptions and approval/use aspects of Inhalation Drug Combination Products internationally, ‘Practically Assessing Emerging Economics for Inhalation Drug Products and Reviewing the Degree of Harmonisation’, Informa, Berlin, 16 September 2013.

Dr. Hoss A Dowlat, When is an ADE, Not an ADR? How the EU’s Redefinition of ADR’s Highlighting Medication Errors Impacts Global Labeling, EU SmPC/US PI, and Pharmacovigilance Strategies.

The new EMA and FDA emphasis on medication errors, International Broadcast, FDANEWS, 28 August 2013.

Dr. Hoss A Dowlat, What is the latest progress of O/D development and regulatory approvals in EMA/FDA/Japan PMDA and ROW? Advances in the evaluation and development of orphan drugs, Executive Circles of O/D Summit, Midfield Media, Copenhagen, 11-13 September 2013.

Dr. Hoss A Dowlat, Understanding the US regulatory system and relating to the EU regulatory framework to facilitate best practices, PTI-Informa, Basle, 24-25 September 2013.

Dr. Hoss A Dowlat, When is an ADE, not an ADR? How the EU’s Redefinition of ADR’s Highlighting Medication Errors Impacts Global Labeling, EU SmPC/US PI, and Pharmacovigilance Strategies?, Pharmaceutical Labelling Summit, Informa Life Sciences, 9 – 10 October 2013.
Dr. Hoss A Dowlat, Highlights of 2013 approval and clinical development status of biosimilars in the EU: international impact, Late breaking Clinical Trial News 2013, ACRP 16th European Conference, Royal Academy of Medicine, Brussels, 14 November 2013.

Dr. Hoss A Dowlat (training, 3-day for Saudi FDA), Introduction to Drug Development and Regulatory Affairs in Major Regions, PTI-Informa, Riyyad, Saudi Arabia, December 2013.

Dr. Hoss A Dowlat, Unique executive oversights into biologics and biosimilars including comparability criteria EMA vs FDA, approval strategy and market penetration, 6th International Seminar, Princeton (Medical Faculty), NJ, USA, 4th August 2014.

Dr. Hoss A Dowlat, The legal and regulatory FDA/EMA labelling framework that drives biosimilar development in the US and EU, Regulatory Considerations and Market Access Strategies for Biosimilars, Informa Life Sciences’ 11th Biosimilars conference, 22 May 2014, Berlin.

Dr. Hoss A Dowlat, Understanding and Reviewing the Common Technical Document Format Dossiers, Venue BRAC CDM, Savar Bangladesh, Directorate General of Drug Administration, Management Sciences for Health (MSH)/SIAPS Program, 23rd to 25th August, 2014.

Dr. Hoss A Dowlat, EMA and FDA Approval Requirements in EU and US, 1st Annual European Biosimilars Conference, Bernstein Research, London, 22 April, 2015.

Dr. Hoss A Dowlat, Executive Update of the US FDA/EU EMA of the New Biosimilars Product Class with Insights into Landmarks, Approval Requirements, Market Penetration and Opportunities, Princeton (Medical Center), NJ (USA), 14th August, 2015, scheduled.

Dr. Hoss A Dowlat, Opportunity of a New Class of Biosimilar Orphan Biologic Medicines Offering Access to Affordable Medicines, Orphan Drugs Summit, Copenhagen, Denmark, 17-18 September, 2015.

Dr. Hoss A Dowlat, European Medicines Agency (EMA) and US FDA view of regulatory aspects of pharmaceutical development of biological medicines resulting in high impact on efficacy and safety, 19th Beijing International Healthcare Industry Forum Biological macromolecules symposium, 22nd Oct, 2015.

Dr. Hoss A Dowlat, Executive Perspectives of the US/EU, FDA/EMA and international status of the New Biosimilar Product Class: Insights, Landmark Approval Requirements and Opportunities, First Primetrics International Biosimilars Seminar (1 Day), Mumbai, India, 5th November, 2015.

Dr. Hoss A Dowlat, Executive Perspectives of the New Biosimilar Product Class: Insights, Landmark Approvals and Opportunities, Biosimilars Workshop, General Aspects/ Regulatory/ Clinical/ Formulation/ Monoclonals/ Insulins, Basle, 23rd November, 2015.

Dr. Hoss A Dowlat, Key considerations of clinical development of biosimilars, Theme 8: Clinical Trial Design of Biosimilar – Part 2 (May 17th), The 8th DIA China Annual Meeting, Beijing, May 15-18, 2016.

Dr. Hoss A Dowlat, Bio-Forum2016, Alert to EMA EU and FDA US regulatory aspects of biologics pharmaceutical development with consequences to efficacy and safety, 18th Shanghai International Forum on Biotechnology & Pharmaceutical Industry, June 20-22, 2016.

 

Webinar presentations (fee paid by attendees) post-2012:
Dr. Hoss A Dowlat with D. Christopher Ohly (Schiff Hardin LLP, Washington, D.C. USA), Interpretation & insights into the FDA draft biosimilar guidances Scientific Considerations, Quality Considerations & Q&A (Regulatory), & provision of an international perspective & context, 2 March 2012.

Dr. Hoss A Dowlat, Comparing and contrasting FDA BIOSIMILARS guidances with EMA EU experience, 27 April 2012.

Dr. Hoss A Dowlat, FDA and EMA successful development and approvals strategy for a biologic, 22 June and 6 July 2012.

Dr. Hoss A Dowlat, EU guidelines on biosimilars of monoclonocal antibodies (mAbs) & impact on comparability of mAbs EMA v FDA, 25 July 2012 (to USA and EU).

Dr. Hoss A Dowlat with M Blüggel (Protagen Protein Service GmbH, Dortmund, Germany), A EU/US Regulatory and Technical Practical Perspective on a Comparability Campaign of Quality and Biological (In vitro) Testing Studies in Support of Biosimilarity, 30August 2012.

Dr. Hoss A Dowlat, EU guidelines on biosimilars of monoclonocal antibodies (mAbs) & impact on comparability of mAbs EMA versus FDA, An overview of the newly released final 2012 EU guidelines on biosimilars of monoclonal antibodies (mAbs) and Indian overarching 2012 guideline, and impact on biosimilars EU-USA-India, 7 September 2012 (to India).

Dr. Hoss A Dowlat, Part 1, EU guidelines on biosimilars of monoclonocal antibodies (mAbs) & impact on comparability of mAbs EMA v FDA EU guidelines on biosimilars of monoclonocal antibodies (mAbs) & impact on comparability of mAbs EMA v FDA; Part 2, The Indian DP/CDSCO Overarching Biosimilars Guideline, 2012.

Dr. Hoss A Dowlat, FDA Approvals and Insights: Understanding US-FDA Drug Regulatory Framework & Comparing & Contrasting with the Complex EU System, 1 March 2013. (To USA.)

Dr. Hoss A Dowlat, Risks of not achieving comparability of biologics, strategies of mitigating such risk, and state of the art practices in Quality-Safety-Efficacy in proving comparability, 18 April, 2013. (To USA.)

Dr. Hoss A Dowlat, Exemplifying the new EMA and FDA emphasis on medication errors including the 2012 EMA redefinition of ADRs, Highlighting possible mitigation strategies internationally, BioPractice, July 18th, 2013.

Dr. Hoss A Dowlat, Ethics Scandal of Big Pharma in China, Personal Insights, 6 September 2013 (To EU/USA clients of Global consulting firm Gerson Lehrman Group).

Dr. Hoss A Dowlat, Highlights of 2013 registration status of biosimilars in the EU, 15 November 2013. (To EU/USA.)

Dr. Hoss A Dowlat, A Landmark for Biosimilars – Part II, Update on biosimilar insulins and mAbs, 21 November, 2013, (To EU/USA clients of Global consulting firm Coleman Research Group).

Dr. Hoss A Dowlat, The different legal and regulatory labelling framework that drives biologics and biosimilar development in the EU and USA, December 13th 2013.

Dr. Hoss A Dowlat, Breakthrough 2013 approvals of biosimilars in EU and current status, and possible impact in USA-Internationally, 5 February 2014.

Dr. Hoss A Dowlat, Current drug development pharmaceutical and clinical efficacy/safety/effectiveness issues facing MAA applicants, 26 February, 2014.

Dr. Hoss A Dowlat, Executive insights into the FDA “Purple Book” Classification and other FDA initiatives regarding biologics and biosimilars, to USA, 26 September 2014.

Dr. Hoss A Dowlat, Unique executive perspectives into biologics and biosimilars; EMA vs FDA, approval strategy and market penetration, Biopractice, to EU/USA, 21 October 2014.

Dr. Hoss A Dowlat, The clinical, regulatory and business challenges and rewards of Orphan development and approval EU and international, Biopractice, to EU/USA, Jan 23, 2015.

Dr. Hoss A Dowlat, Executive insights into the FDA “Purple Book” Classification and other FDA initiatives regarding biologics and biosimilars, Biopractice, to USA, 20 February 2015.

Dr. Hoss A Dowlat, Executive Update of the Biosimilars Product Class followed by Questions and Answers, International Consulting Company GLG, Broadcast to US/EU Financial Sector, 25 February, 2015.

Dr. Hoss A Dowlat, Executive Update of the US/EU status and opportunities of the new Biosimilars Product Class, Biopractice, broadcast to USA industry, 27 May 2015.

Dr. Hoss A Dowlat, Executive insights into the FDA “Purple Book” Classification and other FDA initiatives regarding biologics and biosimilars, Biopractice, broadcast to USA industry, July 10 2015.

Dr. Hoss A Dowlat, Executive Overview of Current Biosimilars Advances, Functional Comparability Studies for Biosimilar Development, Biopharm, international live webcast, June 21, 2016.

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