(Draft, subject to change)
Wednesday 23 January
Opening Ceremony and Welcome speeches
Photo sessions
Cocktails and Drinks
Thursday 24 January
09.00 Advancing International Collaboration; Strategic perspectives
A regulator’s perspective
An Industry perspective
Industry delegate
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?
09.40 Advancing International Collaboration; Possible scenarios
A regulator’s perspective
An Industry perspective
Industry delegate
What collaboration scenarios can be distinguished?
How to deal with differences in ‘maturity’ of homeopathic regulatory tradition?
Bilateral or multinational?
10.20 Regulatory collaboration in EU: Status / lessons learnt EU delegate(s) Status / Lessons learnt are clear
11.10 Regulatory Collaboration between USA and India Status / Lessons learnt Robbert van Haselen Status / Lessons learnt are clear
11.30 Regulatory Collaboration between SAARC-Countries Status / Lessons learnt Indian regulator Status / Lessons learnt are clear
11.50 Regulatory collaboration Russia-India; Russian / Indian Perspectives Russian + Indian regulators Perspectives on possibilities and obstacles
12.30 LUNCH
14.00 Advancing regulatory collaboration between BRICS countries Indian (political) delegate How is collaboration in general between BRICS countries evolving?
Topics to be addressed in parallel groups are clear
Breakout in 3 groups
Group 1; EurAsian Economic Union (EAEU) countries and India
Group 2; Brazil and India
Group 3; South Africa, China, and India
All Non-BRICS delegates will be divided over the three groups Potential bi-lateral or multi-lateral collaboration?
What are priorities for collaboration?
What are the possibilities / obstacles
Is there any ‘low hanging fruit’?
Role European countries / the USA
What are possible next steps?
15.40 Continuation Parallel Group discussions
16.30 PLENARY SESSION: Feedback on the group discussions Group Rapporteurs Main outcomes of the group discussions are fed back to plenum
17.00 FORUM DISCUSSION : Advancing collaborations between BRICS countries All Potential for collaborations is assessed
Can we identify best practices?
Concrete steps are identified as appropriate
18.00 End of day’s program
20.00 Forum Dinner
Friday 25 January
09.00 Harmonization or ‘convergence’ on regulatory standards; Regulators' and Industry perspectives Regulator Industry delegate What is the current status quo globally?
Is ‘convergence’ on standards sufficient? If so, what are the core/minimum requirements?
What are legal/legislative perspectives?
09.40 FORUM DISCUSSION: Global convergence of regulatory standards All How to facilitate global convergence via international collaboration?
What are the priorities?
10.10 Advancing pharmaceutical quality standards; towards a tailored approach? Experiences in Europe Industry Delegate How to tailor safety and quality standards & controls to homeopathic medicines as 'process defined complex medicinal substances'
Theme 1
PARALLEL SESSION 1: Assay development and validation; is collaboration possible? What are challenges and opportunities Is it possible to establish an ‘exchange market' for assays?
Theme 2 PPARALLEL SESSION 2: Theme to be determined
Theme 3 PARALLEL SESSION 3; Theme to be determined
12.00 PLENARY SESSION: Feedback on the group discussions Group Rapporteurs Main outcomes of the group discussions are fed back to plenum
12.30 Lunch
14.00 FORUM DISCUSSION: Comparing the major homeopathic pharmacopoeias Short statements by various delegates followed by plenary discussion How far apart are the pharmacopoeias?
How can we achieve more convergence internationally?
14.50 FORUM DISCUSSION: Towards a regulatory framework that optimally addresses homeopathy as a 'whole systems medical approach' using 'complex medicinal substances'? 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, TCM and Anthroposophical Medicine?
15.40 FORUM DISCUSSION The future of the regulation of homeopathic medicines What are the strategic priorities?
How to advance collaboration
What is on the horizon?
16.20-17.00 FORUM CLOSURE Summing up; feedback on Forum; next steps