Wednesday 23 January |
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| 09:30-13.00 | HPCUS-AYUSH Joint Committee meeting | (To be attended by the concerned people only) | |
| 14.00 | REGISTRATION | ||
| 15.00 | OPENING CEREMONY | ||
| 16.30 | Press Conference | ||
| 17.00 | Photo Session | ||
| TEA & SNACKS | |||
Thursday 24 January |
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TIME |
PRESENTATION / TOPIC |
PRESENTERS / MODERATORS / PARTICIPATION |
OBJECTIVES / QUESTIONS ADDRESSED
|
| 09.00 | Setting the scene: Advancing International Collaboration
In Chair: S. Venkatesh (India) Thomas Breitkreuz (Germany) |
Christiaan Mol (Belgium) Frédéric Ducher (France) Raj K. Manchanda (India) |
Why do we need international collaboration? What kind of lessons have been learnt to date? What kind of opportunities can be generated? What are obstacles? What collaboration scenarios can be distinguished? How to deal with differences in ‘maturity’ of homeopathic regulatory tradition? Bilateral or multinational? |
| 10.10 | Bilateral collaboration: The example of Russia and India | Vadim Merkulov (Russia) Anil Khurana (India) |
What is the current regulatory status quo in Russia
What is the position with regard to bilateral collaboration between Russia and India? |
| 10.40 | TEA / COFFEE | ||
| 11.10 | Regulatory status: Country updates Countries with a homeopathic tradition |
Neil Gower (South Africa) Sandra Chico (Argentina) Diadelis Remirez Figueredo (Cuba) |
Brief country updates Perspectives on collaboration are clarified |
| Countries with an emerging homeopathic tradition: | Ahmed Mohamed Hussein Babiker (Qatar) Ivan Kosalec (Croatia) Monica Yeoh Siu Cheng (Malaysia) Ronko Itamura (Japan) Aaron To/ Yvonne Fok (China/ Hongkong) Chandani Herath (Sri Lanka) |
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| 12.40 |
Pharmaceutical quality / availability Safeguarding the quality of homeopathic medicines in Europe |
Catherine Lang (France) (video link) |
History and role of EDQM is explained Evolution of collaboration within Europe is explained Lessons learnt are shared |
| 13.00-14.00 | LUNCH | ||
| 14.00 |
Advancing pharmaceutical quality standards; towards a tailored approach? Experiences in Europe Safeguarding the availability of homeopathic stocks: The role of the Remedy Bank In chair: Mr. MPS Bakshi (India) Hélène Renoux (France) |
Christiaan Mol (Belgium) Jack Hendrickx (Belgium) |
How to tailor safety and quality standards & controls to homeopathic medicines as 'process defined complex medicinal substances' What are threats to the availability of homeopathic stocks? Current status quo is explained Role of the Remedy Bank in addressing current challenges is explained |
| 14.40 | Integrating Traditional and Integrated Medicine systems in primary healthcare and public health: The example of Brazil The role of National and Regional collaboration Optimizing collaboration with the regulators In chair: Geethakrishnan G. Pillai, WHO (Switzerland) |
Iracema Benvenides (Brazil) Joao Paulo Silvério Perfeito (Brazil) |
How can homeopathy and other TCIM disciplines be integrated into the healthcare system What is the appropriate regulatory framework for integrated healthcare systems What lessons can be learnt from experiences in Brazil, as a ‘Best Practice’ example? |
| 15.20 | TEA / COFFEE | ||
| 15.50 | Traditional, Complementary and Integrated Medicine (TCIM) systems: global advances in public health and regulation In chair: Dr. S.S. Savrikar (India) |
Geethakrishnan G. Pillai, WHO (Switzerland) Thomas Breitkreuz (Germany) |
What is the role of the WHO and other Global collaboration platforms? How to optimally link the regulation of TCIM medicinal products to the regulation of TCIM systems as a whole? What is on the horizon for TCIM systems, with particular reference to homeopathy as a globally established TCIM modality and global healthcare challenges of the 21st century |
| 16.30 | FORUM DISCUSSION Round table discussion on advancing collaboration between BRICS Countries |
Vadim Merkulov (Russia) Joao Paulo Silvério Perfeito (Brazil) Neil Gower (South Africa) Anil Khurana (India) |
What are the specific opportunities offered by BRICS? What are the priorities for regulatory collaboration? How can regulatory collaboration be taken forward concretely? |
| 17.00 | FORUM DISCUSSION Advancing collaboration among other countries: SAARC, EURASIA, EUROPE, LATIN AMERICA, USA |
All | What are priorities and opportunities for international collaboration in the regulation of HMP´s? Can we identify best practices / models on a bi-national, regional, cross-cultural and global level? |
| 18.00 | END OF DAY’S PROGRAM | ||
| 20.00 | FORUM DINNER | ||
Friday 25 January |
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| 09.00 | Harmonization or ‘convergence’ on regulatory standards; Regulators' and Industry perspectives In chair: Joao Paulo Silvério Perfeito (Brazil) |
Christiane Kirchner (Germany) Gunther Herr (Germany) |
What is the current status quo globally? Is ‘convergence’ on standards sufficient? If so, what are the core/minimum requirements What are legal perspectives? How can coherence between standards be achieved as illustrated by a comparison between the European and Eurasian Economic Union laws |
| 10.00 | New homeopathic drug approval: Perspectives on setting appropriate requirements for provings and clinical data In chair: J.D. Daryani (India) L.K. Nanda (India) |
Todd Hoover (USA) Robbert van Haselen (UK) Rajesh Shah (India) |
What is the role of provings in underpinning the ‘homeopathic nature’ of the medicine? What are reasonable clinical effectiveness requirements for new homeopathic medicines? |
| 10.30 | Challenges faced by the homoeopathic industry In chair: K.S. Sethi (India) GVR Joseph (India) |
Ashish Kumar (India) Mudita Arora (India) S. M. Nurul Hoque (Bangladesh) Nishant Jain (India) |
How is the Indian regulatory system perceived? What are perceived problems with regard to exporting Indian homeopathic medicines? How can the Indian Industry connect internationally? |
| 11.00 | TEA / COFFEE | ||
| 11.30 | PARALLEL SESSIONS | ||
| Theme 1 | Ensuring the quality and safety of products for patients and consumers; what are appropriate standards for homeopathy? In chair: Jayesh Bellare, (India) Arvind Kothe (India) |
Eric Foxman (USA) K.C. Reddy (India) S.R. Chinta (India) |
How to establish realistic requirements that provide adequate assurance of quality and safety while avoiding unreasonable or illogical demands upon industry. |
| Theme 2 | Ensuring the quality and safety of products made from biological substances In chair: Raj K. Manchanda (India) S.P. Shani (India |
Shailendra Saxena (India) Sukhbir Kaur (India) Rajesh Shah (India) Jack Hendrix (Belgium) Ilse Muchitsch (Austria) Diadelis Remirez Figueredo (Cuba) Ivan Kosalec (Croatia) |
Quality and safety parameters for nosodes and sarcodes Further clarification of status with regard to nosodes and sarcodes What are the challenges? Is knowledge transfer/exchange possible between countries |
| Theme 3 | Obtaining clinical data on new and existing homeopathic medicines In chair: Todd Hoover (USA) |
Robbert van Haselen (UK) Anil Khurana (India) Theodoros Lilas (Greece |
How can the homeopathic community work together to obtain clinical effectiveness on new as well as existing medicines What is the role of homeopathic software platforms and Information technology in facilitating the collection of clinical data |
| Theme 4 | Regulatory challenges with regard to the use of Homoeopathy in Veterinary Medicine In chair: Edward de Beukelaer (UK) Ramankutty P. (India) |
Petra Weiermayer (Austria) Shivang Swaminarayan (India) Surjeet Singh Makkar (India) P.K. Naveen (India) K.V. Athman (India) |
Regulatory framework for veterinary medicine in different countries is discussed and compared Potential for international collaboration is explored Recommendations for India, and other countries |
| 13.00 | LUNCH | ||
| 14.00 | PLENARY SESSION: Feedback on the group discussion |
Group Coordinators | Main outcomes of the group discussions are fed back to plenum |
| 15.00 | FORUM DISCUSSION: Comparing the major homeopathic pharmacopoeias: Short presentations on pharmacopoeias, followed by discussion In chair: K.C. Reddy (India) Anil Khurana (India) |
Europe (Austria): Ilse Muchitsch USA: Eric Foxman Russia: Vadim Merkulov Brazil: Joao Paulo Silvério Perfeito India: GVR Joseph |
How far apart are the pharmacopoeias? Is further international exchange of information needed and feasible? How can more international convergence be achieved? |
| 15.50 | FORUM DISCUSSION: Towards a regulatory framework that optimally addresses homeopathy as a 'whole systems medical approach' using 'complex medicinal substances'? The Future of homeopathic regulation |
Perspectives by selected attendees followed by plenary discussion | Can/should regulatory frameworks evolve further to recognize the specific characteristics of homeopathy as a therapeutic system? Can lessons be learnt from other 'whole system medical approaches' that use complex substances such as Ayurveda and Anthroposophical Medicine? How to advance collaboration; concrete steps Does negative media coverage affect regulators / regulation? If so, how can we inform the regulators and present a balanced picture in the media? What is on the horizon? |
| 16.40-17.00 | FORUM CLOSURE | Summing up; feedback on Forum; next steps | |